Trial Condition(s):
Biochemically recurrent prostate cancer
A study to compare darolutamide given with Androgen Deprivation Therapy (ADT) with ADT in men with hormone sensitive prostate cancer and raise of Prostate Specific Antigen (PSA) levels after local therapies (ARASTEP)
Bayer Identifier:
21492
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2022-501343-33-00
Trial Purpose
Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer.
BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat.
In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments.
The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months.
To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a “tracer” that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells.
To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy.
During the study, the study team will:
• take blood and urine samples.
• measure PSA and testosterone levels in the blood samples
• do physical examinations
• check the participants’ overall health
• examine heart health using electrocardiogram (ECG)
• check vital signs
• check cancer status using PSMA PET/CT scans, CT, MRI and bone scans
• take tumor samples (if required)
• ask the participants if they have medical problems
About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants’ health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first.
Inclusion Criteria
- Capable of giving signed informed consent as described which includes compliance with the requirements, restrictions listed in the informed consent form (ICF), and in this protocol. - Male ≥18 years of age at the time of signing the informed consent. - Histologically or cytologically confirmed adenocarcinoma of prostate. - Prostate cancer initially treated by: radical prostatectomy (RP) followed by adjuvant radiotherapy (ART), or salvage radiotherapy (SRT), or RP in participants who are unfit for (or refused) ART or SRT, or primary radiotherapy (RT). - High-risk biochemical recurrence (BCR), defined as Prostate-specific antigen doubling time (PSADT) <12 months calculated using the formula provided by the Sponsor, and PSA ≥0.2 ng/mL after ART or SRT post RP or after RP in participants who are unfit for ART or SRT (local or central values accepted), or PSA ≥2 ng/mL above the nadir after primary RT only (local or central values accepted). - Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 42-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessed by blinded independent central review (BICR) to identify at least one PSMA PET/CT lesion of prostate cancer. - Serum testosterone ≥150 ng/dL (5.2 nmol/L) (local assessment is allowed whenever central assessment cannot be done). - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Blood counts at screening: Hemoglobin ≥9.0 g/dL (participant must not have received blood transfusion within 7 days prior to sample being taken); Absolute neutrophil count (ANC) ≥1.5x10^9/L (participant must not have received any growth factor within 4 weeks prior to sample being taken); Platelet count ≥100x10^9/L. - Screening values of: Alanine aminotransferase (ALT) ≤1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) ≤1.5 x ULN; Total bilirubin (TBL) ≤1.5 ULN, (except participants with a diagnosis of Gilbert’s disease); Estimated glomerular filtration rate (eGFR) >40 ml/min/1.73 m^2 calculated by the CKD-EPI formula. - Sexually active male participants must agree to use contraception as detailed in the protocol during the Treatment period and for at least 1 week after the last dose of study treatment, and refrain from donating sperm during this period.
Exclusion Criteria
- Pathological finding consistent with small cell, ductal or ≥50 % component of neuroendocrine carcinoma of the prostate. - History of bilateral orchiectomy. - Metastases or recurrent /new malignant lesions in prostate gland/bed seminal vesicles, lymph nodes below the CIA bifurcation on conventional imaging (CI) as assessed by BICR during screening. - Brain metastasis on PSMA PET /CT by BICR at screening. - High-risk BCR after primary radiotherapy with new loco-regional lesions on screening PSMA PET/CT who are eligible for curative salvage prostatectomy. Note: Participants treated with curative salvage prostatectomy after primary RT who meet the PSA criteria (inclusion criteria 5) may be considered for the study. - Prior treatment with second generation (e.g. enzalutamide, apalutamide) androgen receptor inhibitors (ARIs) and CYP 17 inhibitors (e.g., abiraterone) within 18 months prior to signing of the ICF. - Prior treatments with PSMA-radiotherapeutics within 12 months prior to randomization. - Prior radiotherapy (including image-guided radiotherapy) as primary, adjuvant or salvage treatment completed within 8 weeks prior to signing of the ICF. - Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years. - History of pelvic radiotherapy for other malignancy.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Medizinische Universität Wien Universitätsklinik f. Innere Medizin I Klinische Abteilung für Onkologie Wien, Austria, 1090 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ordensklinikum Linz GmbH Elisabethinen Linz, Austria, 4020 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krankenhaus der Barmherzigen Brüder Vienna, Austria, 1020 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dana-Farber Cancer Institute Boston, United States, 02115-6084 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Carolina Urological Research Center Myrtle Beach, United States, 29579 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Colorado Urology (Colorado Clinical Research) Lakewood, United States, 80228 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urology San Antonio, PA dba USA Clinical Trials San Antonio, United States, 78229 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations White Plains Hospital White Plains, United States, 10601 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tower Urology, Inc Los Angeles, United States, 90048 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MidLantic Urology - Bala Cynwyd Bala Cynwyd, United States, 19004 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Alliance Urology Specialists Greensboro, United States, 27403 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations New Jersey Urology, LLC Voorhees, United States, 08043 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Barbara Ann Karmanos Cancer Institute - Detroit Detroit, United States, 48201 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Kansas Kansas City, United States, 66160 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Southern California Los Angeles, United States, 90033 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of California, Los Angeles Los Angeles, United States, 90095 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NYU Langone Health New York, United States, 10016 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Texas MD Anderson Cancer Center Houston, United States, 77030 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Johns Hopkins Univ School Med|Sidney Kimmel Comp Cancer Cntr Baltimore, United States, 21231 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urology Austin, PLLC (an affiliate of Urology America) Austin, United States, 78745 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mayo Clinic Hospital Phoenix, United States, 85054 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Urology Group Cincinnati, United States, 45212 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UCSF Med Center Helen Diller Family Comp Cancer Center San Francisco, United States, 94143 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City of Hope National Medical Center Durate, United States, 91010 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Washington University School of Medicine St. Louis, United States, 63110-1093 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut de Cancérologie de l'Ouest - Saint Herblain Saint-Herblain, France, 44800 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Gustave Roussy - Département de Médecine Oncologique VILLEJUIF CEDEX, France, 94805 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Pellegrin - Bordeaux BORDEAUX, France, 33000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Bichat - Paris PARIS, France, 75018 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Lyon Sud PIERRE BENITE, France, 69495 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Jean Perrin CLERMONT-FERRAND, France, 63011 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Claude Huriez - Lille LILLE, France, 59037 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Pontchaillou RENNES CEDEX, France, 35033 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniklinikum Salzburg - Landeskrankenhaus Salzburg, Austria, 5020 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mount Vernon Cancer Centre Northwood, United Kingdom, HA6 2RN | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Marsden Hospital (London) London, United Kingdom, SW3 6JJ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charing Cross Hospital London, United Kingdom, W6 8RF | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Minnesota Medical Center Minneapolis, United States, 55455 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northwestern University Feinberg School of Medicine - Department of Urology Chicago, United States, 60611 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Michigan Institute of Urology, PC Troy, United States, 48084 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Puerta del Mar Cadiz, Spain, 11009 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MD Anderson International Espanya, S.A. Madrid, Spain, 28033 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de la Victoria | Cardiology Department Málaga, Spain, 29010 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08023 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Fundació Puigvert Barcelona, Spain, 08025 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto Valenciano de Oncología Valencia, Spain, 46009 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Ramon y Cajal | Departamento de Medicina Interna Madrid, Spain, 28034 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations H. General Uiversitario Morales Meseguer - Department of Urology Murcia, Spain, 30008 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Integral Oncológico Clara Campal Madrid, Spain, 28050 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Princess Margaret Cancer Centre - UHN Toronto, Canada, M5G 2M9 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Joseph's Healthcare - Hamilton Hamilton, Canada, L8P 3B6 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sir Mortimer B. Davis Jewish General Hospital - Radiation Oncology Montreal, Canada, H3T 1E2 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vancouver Prostate Centre Vancouver, Canada, V5Z 1M9 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Prostate Cancer Centre Calgary, Canada, T2V 1P9 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Hotel-Dieu de Levis Levis, Canada, G6V 3Z1 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations BCCA-Vancouver Island Centre Victoria, Canada, V8R 6V5 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Prince of Wales Hospital NSW Randwick, Australia, 2031 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Austin Health Heidelberg, Australia | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations South Western Sydney Local Health District | Liverpool Hospital - Stroke and Neurovascular Department Liverpool, Australia, 2170 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sydney Adventist Hospital Wahroonga, Australia, 2076 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Epworth HealthCare East Melbourne, Australia, 3002 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IPO Lisboa Lisboa, Portugal, 1093 CODEX | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Luz Saude | Hospital da Luz Lisboa - Centro de Investigacao Clinica Lisboa, Portugal, 1500-650 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University College London Hospitals NHS Foundation Trust London, United Kingdom, NW1 2PQ | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Canterbury Urology Research Trust Christchurch, New Zealand, 8013 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Auckland City Hosptial Auckland, New Zealand, 1023 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tauranga Urology Research Limited Tauranga, New Zealand, 3112 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Assistência Multidisciplinar em Oncologia (AMO) Salvador, Brazil, 41950-640 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto do Cancer do Estado de Sao Paulo São Paulo, Brazil, 01246-000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Faculdade de Medicina do ABC Santo André, Brazil, 09060-650 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inst. de Assistência Médica ao Sérvidor Público Estadual São Paulo, Brazil, 04039-004 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica Natal, Brazil, 59062-000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Sirio Libanes Sao Paulo, Brazil, 01308-050 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner Curitiba, Brazil, 81520-060 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Münster (UKM) Münster, Germany, 48149 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum rechts der Isar München, Germany, 81675 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsmedizin der Georg-August-Universität Göttingen Göttingen, Germany, 37075 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Köln Köln, Germany, 50937 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum der Universität Würzburg Würzburg, Germany, 97080 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Städtisches Klinikum Braunschweig gGmbH Braunschweig, Germany, 38126 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Fakultät der Otto-von-Guericke Universität Magdeburg, Germany, 39120 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum der Johann Wolfgang Goethe Universität Frankfurt, Germany, 60596 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Studienpraxis Urologie Nürtingen, Germany, 72622 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ICANS - Institut de Cancérologie de Strasbourg Europe STRASBOURG, France, 67033 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Bretonneau TOURS, France, 37044 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tokyo Medical and Dental University Hospital Bunkyo-ku, Japan, 113-8519 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyoto University Hospital Kyoto, Japan, 606-8507 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kanazawa University Hospital Kanazawa, Japan, 920-8641 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osaka University Hospital Suita, Japan, 565-0871 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yokohama City University Hospital Yokohama, Japan, 236-0004 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kagoshima University Hospital Kagoshima, Japan, 890-8520 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ospedale San Raffaele s.r.l. Milano, Italy, 20132 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Modena - Policlinico Modena, Italy, 41124 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Centro di Riferimento Oncologico (CRO) Pordenone, Italy, 33081 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O. di Perugia - Ospedale Santa Maria della Misericordia Perugia, Italy, 06123 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ist Nazionale Tumori GE - Oncologia Medica Genova, Italy, 16132 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Santa Chiara Hospital Trento, Italy, 38122 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istituto Nazionale Tumori IRCCS Fondazione G.Pascale Napoli, Italy, 80131 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL-IRCCS di Reggio Emilia Reggio Emilia, Italy, 42123 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Molinette Hospital University of Torino Torino, Italy, 10126 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Istituti Fisioterapici Ospitalieri - IFO Roma, Italy, 00144 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL di Bologna Bologna, Italy, 40139 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Virgen del Rocio University Hospital - Oncology Department Sevilla, Spain, 41013 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHULN - H. Sta.Maria (Centro de Investigacao Clinica) Lisboa, Portugal, 1649-035 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Companhia Uniao Fabril | Hospital CUF Tejo - Academic Center - Research Center Lisboa, Portugal, 1350-352 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department São Paulo, Brazil, 05651-901 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Moinhos de Vento-Centro Clínico Porto Alegre, Brazil, 90035-001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Turun yliopistollinen keskussairaala Turku, Finland, FIN-20521 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oulun yliopistollinen sairaala Oulu, Finland, 90220 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HUS, Meilahden sairaala Helsinki, Finland, 29 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tampereen yliopistollinen sairaala, keskussairaala Tampere, Finland, 33520 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Surrey County Hospital Guildford, United Kingdom, GU2 7XX | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut Curie - Ulm - Paris PARIS cedex 5, France, 75248 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU GRENOBLE - Hopital Michallon GRENOBLE, France, 38048 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Ospedali Riuniti Foggia Foggia, Italy, 71100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Prince Alfred Hospital Camperdown, Australia, 2050 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Clinical Research Unit - Box Hill Box Hill, Australia, 3128 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Innsbruck Innsbruck, Austria, 6020 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Urology Place San Antonio, United States, 78240 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istituto Oncologico Veneto IRCCS (IOV) Padova, Italy, 35128 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Papa Giovanni XXIII Bergamo, Italy, 24127 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione PTV Policlinico Tor Vergata Roma, Italy, 00133 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum Mannheim GmbH Mannheim, Germany, 68167 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Allegheny General Hospital Pittsburgh, United States, 15212 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. Milano, Italy, 20089 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vivantes Klinikum Am Urban Berlin, Germany, 10967 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Skane University Hospital - Department of Urology Malmo, Sweden, 20502 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Goteborgs Universitet Gothenburg, Sweden, 413 45 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rigshospitalet Copenhagen, Denmark, 2100 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Carl Gustav Carus Dresden Dresden, Germany, 01307 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Italy, 00168 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna, Italy, 40138 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aarhus Universitetshospital Aarhus N, Denmark, 8200 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aalborg University Hospital Aalborg, Denmark, 9000 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations London Regional Cancer Program London, Canada, N6A 4L6 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Cabrini Medical Centre Malvern, Australia, 3144 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fudan University Shanghai Cancer Center Shanghai, China, 200030 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Peking Union Medical College Hospital (PUMCH) - East Location Beijing, China, 100730 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The 1st Affiliated Hospital of Zhejiang University Hangzhou, China, 310000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nova Scotia Health Authority Halifax, Canada, B3H 2Y9 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont Sherbrooke, Canada, J1H 5N4 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut de Cancérologie Jean Godinot Reims, France, 51726 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nanjing First Hospital Nanjing, China, 210006 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Marien-Krankenhaus Bergisch Gladbach Bergisch Gladbach, Germany, 51465 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chesapeake Urology Associates Baltimore, United States, 21204 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urology Cancer Center, PC Omaha, United States, 68130-5606 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitaetsklinikum Jena - Klinik fuer Urologie Jena, Germany, 7747 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Melbourne Hospital Melbourne, Australia, 3052 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institue Curie - Saint-Cloud SAINT-CLOUD, France, 92210 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Maisonneuve-Rosemont Montreal, Canada, H1T 2M4 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine Shanghai, China, 200025 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zhongnan hospital ,Wuhan University Wuhan, China, 430033 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West China Hospital,Sichuan University Chengdu, China, 610041 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations BC Cancer - Abbotsford Centre Abbotsford, Canada, V2S 0C2 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Affiliated Hospital of Inner Mongolia Medical University Hohehot, China, 10050 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tianjin Cancer Hospital, Airport Hospital Tianjin, China, 300308 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Swietokrzyskie Centrum Onkologii Kielce, Poland, 25-734 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University Nanjing, China, 210029 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hunan Cancer Hospital Changsha, China, 410013 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sir Charles Gairdner Hospital Nedlands, Australia, 6009 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HagaZiekenhuis van Den Haag The Hague, Netherlands, 2545 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Albert Schweitzer Ziekenhuis - Dordwijk Dordrecht, Netherlands, 3300 AK | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Catharina Ziekenhuis EINDHOVEN, Netherlands, 5623 EJ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Medical Center Groningen | Urology Department GRONINGEN, Netherlands, 9713 GZ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Franciscus Gasthuis ROTTERDAM, Netherlands, 3045 PM | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Antonius Ziekenhuis | Utrecht - R&D Interne Geneeskunde NIEUWEGEIN, Netherlands, 3435 CM | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tergooi MC | Hilversum - Wetenschapsbureau HILVERSUM, Netherlands, 1213 XZ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Gent - department Urology Gent, Belgium, 9000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Groeninge Campus Kennedylaan - Urology Kortrijk, Belgium, 8500 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jessa Hospital | Campus Virga Jesse - Data Management Oncology and Hematology Department Hasselt, Belgium, 3500 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitair Ziekenhuis Leuven | Gasthuisberg Campus - Urology Department Leuven, Belgium, 3000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Maria Middelares - Oncology Gent, Belgium, 9000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northern Hospital Epping, Australia, 3076 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP) Brno, Czech Republic, 602 00 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Koo Foundation Sun Yet-Sen Cancer Centre Taipei, Taiwan, China, TBC | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital at Linkou Taoyuan, Taiwan, China, 33305 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tungs' Taichung MetroHarbor Hospital Taichung, Taiwan, China, 435403 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika Olomouc, Czech Republic, 779 00 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Brisbane & Women's Hospital Brisbane, Australia, 4029 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Western Urology Maribyrnong, Australia, 3032 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centrum Medyczne iMed24 Krakow, Poland, 31-864 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medrise Sp. z o.o. Centrum Badan Klinicznych Lublin, Poland, 20-582 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vseobecna fakultni nemocnice - Urologicka klinika, Praha Praha 2, Czech Republic, 128 08 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice u Sv. Anny, Onkologicko-chirurgicke oddeleni Brno, Czech Republic, 602 00 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiscan s.r.o., Department: Ambulance klinické onkologie Nemocnice Horovice Horovice, Czech Republic, 26801 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Martini-Klinik Hamburg Hamburg, Germany, 20246 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centrum Onkologii im. Prof. Franciszka Lukaszczyka Bydgoszcz, Poland, 85-796 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Barwon Health Geelong, Australia, 3220 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szpital Grochowski im. dr.med. Rafala Masztaka Warszawa, Poland, 04-073 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Semmelweis Egyetem, Altalanos Orvostudomanyi Kar, Urologiai Klinika Budapest, Hungary, 1082 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet Budapest, Hungary, 1024 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Orszagos Onkologiai Intezet Budapest, Hungary, 1122 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz Gyor, Hungary, 9024 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Budapesti Uzsoki Utcai Korhaz Budapest, Hungary, 1145 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz Nyiregyhaza, Hungary, H-4400 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations EMC Instytut Medyczny SA Wroclaw, Poland, 54-144 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar e Universitario de Coimbra EPE (CHUC) Coimbra, Portugal, 3004-561 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Marienhospital Herne Universitätsklinik Herne, Germany, 44625 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Johannes Gutenberg-Universität Mainz - Urologie Mainz, Germany, 55131 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universitaet Graz - Klinische Abteilung für Onkologie - Innere Medizin Graz, Austria, 8036 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinique Clementville Montpellier, France, 34070 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Georges Francois Leclerc Dijon DIJON, France, 21079 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre d'oncologie du Pays Basque Bayonne, France, 64100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Institut de Cancérologie de Lorraine - Alexis Vautrin Vandoeuvre-les-Nancy, France, 54519 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Blacktown Hospital Blacktownn, Australia, 2148 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Assistance Publique-Hopitaux de Paris (AP-HP) - Hopitaux Universitaires Henri Mondor (Hopital Henri-Mondor) Creteil, France, 94000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital de la Timone - Marseille MARSEILLE, France, 13005 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Adelaide Hospital Adelaide, Australia, 5000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Texas Southwestern Medical Center-Harold C. Simmons Comprehensive Cancer Center Dallas, United States, 75235 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kaye Edmonton Clinic - Dianne and Irving Kipnes Urology Centre Edmonton, Canada, T6G 1Z1 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CISSS de l'Outaouais - Hopital de Gatineau - Centre de cancerolgie Gatineau, Canada, J8P 7H2 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec - Radio-oncologie Trois-rivieres, Canada, G8Z 3R9 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urology South Shore Research - Research Department Quebec, Canada, J4V 2H3 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MidCentral District Health Board (MDHB) - Palmerston North Hospital (PNH) TBC, New Zealand, 4414 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Real e Benemérita Associação Portuguesa de Beneficência São Paulo, Brazil, 01323-001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universidade Estadual do Rio de Janeiro Rio de Janeiro, Brazil | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital do Cancer de Sao Paulo - A. C. Camargo Sao Paulo, Brazil, 01509-900 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Alemao Oswaldo Cruz Sao Paulo, Brazil | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Sirio Libanês - Hospital Base de Brasilia Brasilia, Brazil, 70200-730 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oncocentro - Fortaleza Fortaleza, Brazil, 60135-237 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital São Rafael Salvador, Brazil, 41253-190 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Real Hospital Português Recife, Brazil, 50070-160 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urologicum Duisburg Duisburg, Germany, 47169 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urologische Gemeinschaftspraxis Wesel Wesel, Germany, 46483 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital de La Louvière - Site Jolimont - Oncology department La Louvière, Belgium, 7100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice v Motole, Onkologicka klinika 2. LF UK a FN Motol Prague, Czech Republic, 150 00 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR)Timeframe: After randomization to after last treatment, approximately 24 months
Secondary Outcome
- Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICRTimeframe: After randomization to after last treatment, approximately 46 months
- Time to Castration-resistant prostate cancer (CRPC) assessed by investigatorTimeframe: After randomization to after last treatment, approximately 46 months
- Time to initiation of first subsequent systemic antineoplastic therapyTimeframe: After randomization to after last treatment, approximately 46 months
- Time to loco-regional progression by PSMA PET/CTTimeframe: After randomization to after last treatment, approximately 46 months
- Time to first Symptomatic skeletal event (SSE)Timeframe: After randomization to after last treatment, approximately 46 months
- Overall survival (OS)Timeframe: After randomization to after last treatment, approximately 46 months
- Prostate-specific antigen (PSA) undetectable rates (<0.2 ng/mL)Timeframe: After randomization to after last treatment, approximately 46 months
- Time to deterioration in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total scoreFACT-P is a multidimension, selfreport QoL instrument specifically designed for patients with prostate cancer. It consists of 39 questions items, made up by 2 parts: the 27 questions for functional assessment of cancer therapy general (FACT-G) and 12 prostate cancer subscale questions. It assesses 4 main domains which are: physical (n=7), social/family (n=7), emotional (n=6) and functional wellbeing (n=7).Timeframe: After randomization to after last treatment, approximately 24 months
- Time to symptomatic progressionTimeframe: After randomization to after last treatment, approximately 46 months
- Number of participants with Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) categorized by severityTimeframe: After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months
- Number of participants who discontinue study treatment due to a TEAETimeframe: After the first treatment until 30 days (+7 days) after the last treatment, up to 25 months
Additional Information
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