Trial Condition(s):
Biochemically recurrent prostate cancer
A study to compare darolutamide given with Androgen Deprivation Therapy (ADT) with ADT in men with nonmetastatic prostate cancer and raise of Prostate Specific Antigen (PSA) levels after local therapies (ARASTEP)
Bayer Identifier:
21492
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
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 for prostate cancer development. This may mean that the cancer has come back even though no cancer or cancer spreading is yet detectable using conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans. 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 men with a stage of prostate cancer where the PSA levels raised to a certain limit within a specified 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. Next generation androgen receptor inhibitors (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 and ADT given for 24 months. A placebo is a treatment that looks like a medicine but does not have any medicine in it.
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 will 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 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, or PSA ≥2 ng/mL above the nadir after primary RT only. - Participants must undergo prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 30-day Screening period using either 18F-DCFPyL (piflufolastat F 18) or 68Ga-PSMA-11 which will be assessed by BICR. - Serum testosterone ≥150 ng/dL (5.2 nmol/L). - 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 3 months 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 Universitätsklinikum AKH Wien Wien, Austria, 1090 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ordensklinikum Linz GmbH Elisabethinen Linz, Austria, 4020 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krankenhaus der Barmherzigen Brüder Wien, 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 Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Colorado Urology (Colorado Clinical Research) Lakewood, United States, 80228 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urology San Antonio Research, PA San Antonio, United States, 78229 | Status Not yet 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 First Urology PSC Jeffersonville, United States, 47130 | 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 Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MidLantic Urology Bala Cynwyd, United States, 19004 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Alliance Urology Greensboro, United States, 27403 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ohio State University Wexner Medical Center Columbus, United States, 43210 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Arizona Institute of Urology Tucson, United States, 85704 | Status Not yet 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 Associated Medical Professionals of NY, PLLC Syracuse, United States, 13210 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urological Associates of Lancaster Lancaster, United States, 17604 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bon Secours St. Francis Hospital Greenville, United States, 29607 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Florida - Jacksonville Jacksonville, United States, 32209 | 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 Not yet 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 Comprehensive Cancer Center Chicago, United States, 60637 | 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 Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Urology of Indiana, LLC Greenwood, United States, 46143 | Status Not yet 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, 78759 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clermont Oncology Center Clermont, United States, 34711 | 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 Wake Forest Baptist Health Winston Salem, United States, 27157 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mid Florida Cancer Centers Orange City, United States, 32763-8316 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jesse Brown VA Medical Center Chicago, United States, 60612 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Pittsburgh Pittsburgh, United States, 15232 | 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 Not yet 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 Cancerologie de Ouest - Saint Herblain St Herblain, France, 44805 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gustave Roussy (Institut de Cancerologie Gustave-Roussy) Villejuif, France, 94805 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hôpital Pellegrin - Bordeaux BORDEAUX, France, 33000 | Status Not yet 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 Not yet 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 Not yet 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 University of California Irvine Medical Center Orange, United States, 92868-3201 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northwestern University Feinberg School of Medicine Chicago, United States, 60611 | Status Not yet 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 Not yet 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 Virgen de la Victoria Málaga, Spain, 29010 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08023 | Status Not yet 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 Not yet 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 Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Ramón y Cajal 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 Hospital Madrid Norte Sanchinarro 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 Hamilton Health Sciences-Juravinski Cancer Centre Hamilton, Canada, L8V 5C2 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T 1E2 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vancouver General Hospital Vancouver, Canada, V6H 3Z6 | 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 Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations BCCA-Vancouver Island Centre Victoria, Canada, V8R 6V5 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clalit Health Services Rabin Medical Center-Beilinson Campus Petah Tikva, Israel, 4941492 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Macquarie University Hospital Macquarie University, Australia, 2109 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations GenesisCare Newcastle Newcastle, Australia, 2290 | Status Not yet 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 St Vincents Hospital Sydney Sydney, Australia, 2010 | 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 Liverpool Hospital 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 Port Macquarie Base Hospital Port Macquarie, Australia, 2444 | 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 Tasman Health Care Southport, Australia, 4215 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IPO Lisboa Lisboa, Portugal, 1099-023 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital da Luz - Lisboa 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 Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bedford Hospital - Bedfordshire Hospitals NHS Foundation Tru Bedford, United Kingdom, MK42 9DJ | Status Not yet 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 | 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 Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto do Câncer do Estado de São 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 Câncer Natal, Brazil, 59062-000 | Status Not yet 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 Not yet 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 Klinikum der Johann-Wolfgang-Goethe-Universitaet Frankfurt M Frankfurt a. M., Germany, 60590 | 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 Not yet 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 Not yet 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 Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yokohama City University Hospital Yokohama, Japan, 236-0004 | Status Not yet 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.I. Verona Verona, Italy, 37126 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Consorziale Policlinico Bari, Italy, 70124 | 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 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA 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 Not yet 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 Fondazione IRCCS Istituto Nazionale dei Tumori Milano, Italy, 20133 | 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 Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Istituti Fisioterapici Ospitalieri - IFO Roma, Italy, 00144 | Status Not yet 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 Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundacao Champalimaud Lisboa, Portugal, 1400-038 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar Universitário de Lisboa Norte | Heart and Vessels Department Lisboa, Portugal, 1649-028 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital CUF Tejo Lisboa, Portugal, 1350-352 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Clinico Academico - Braga Braga, Portugal, 4710-243 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Israelita Albert Einstein 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 Docrates Klinikka Helsinki, Finland, 00180 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Turun yliopistollinen keskussairaala Turku, Finland, FIN-20521 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oulun yliopistollinen sairaala Oulu, Finland, 90220 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tampereen yliopistollinen sairaala, keskussairaala Tampere, Finland, 33520 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HUS, Meilahden sairaala Helsinki, Finland, 00290 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Surrey County Hospital NHS Foundation Trust Guildford, United Kingdom, GU2 7WG | 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: clinical[email protected] Phone: (+)1-888-84 22937 |
Locations Bundaberg Hospital, Genesis Cancer Care - Bundaberg Bundaberg, Australia, 4670 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wide Bay Hospital and Health Service - Hervey Bay Hospital Pialba, Australia, 4655 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Innsbruck Innsbruck, Austria, 6020 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shaare Zedek Medical Center Jerusalem, Israel, 9372212 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sheba Medical Center Tel Hashomer, Israel, 52621 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sourasky Medical Center Tel-Aviv, Israel, 64239 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Urology Place San Antonio, United States, 78257 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IOV Castelfranco Veneto Castelfranco Veneto, Italy, 31033 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ospedale Sacro Cuore Don Calabria Verona, Italy, 37024 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Papa Giovanni XXIII Bergamo, Italy, 24127 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations 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 Universitaetsklinikum 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 Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ist Clinico Humanitas Rozzano, 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 Not yet 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 Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Charité Campus Benjamin Franklin (CBF) Berlin, Germany, 12203 | Status Not yet 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 Policlinico Gemelli Rome, Italy, 168 | 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 Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aalborg University Hospital Aalborg, Denmark, 9000 | Status Not yet 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 Nanjing First Hospital Nanjing, China, 210006 | 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 Not yet 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 New Jersey Urology (NJU) Saddle Brook, United States, 07663-5227 | 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 Not yet 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 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
- 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
Copyright © Bayer
Powered by
