Trial Condition(s):

Prostatic Neoplasms

Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastases

Bayer Identifier:

16216

ClinicalTrials.gov Identifier:

NCT01618370

EudraCT Number:

2012-000075-16

Study Completed

Trial Purpose

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product.

Inclusion Criteria

- Age ≥18 years of age
 - Histologically or cytologically confirmed prostate cancer
 - Patients diagnosed with progressive bone predominant metastatic CRPC/HRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed) 
 - Progressive disease is defined either by:
 -- The appearance of new bone lesions. If progression is based on new lesion(s) on imaging only without an increase in prostate specific antigen (PSA), PSA values from 3 assessments within the last 6 months must be provided;   OR
 -- In the absence of new bone lesions by 2 subsequent increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥ 5 ng/mL. (The reference value time point 1, is defined as the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart. If the PSA at time point 3 is greater than the PSA at time point 2, then eligibility has been met. If the PSA at time point 3 is not greater than the PSA at time point 2 but the PSA value at time point 4 and/or time point 5 is greater than the PSA at time point 2, the patient is eligible assuming that other criteria are met) 
 - Life expectancy ≥ 6 months
 - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 - 2
 - Adequate hematological, liver, and renal function
 -- Absolute neutrophil count (ANC) ≥ 1.5 x10^9/L
 -- Platelet count ≥ 100 x10^9/L 
 -- Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
 -- Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
 -- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN 
 -- Creatinine ≤ 1.5 x ULN
 -- Albumin > 25 g/L

Exclusion Criteria

- Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
 - Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available
 - Treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs (adverse events) due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted)
 - Prior hemibody external radiotherapy is excluded.  Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets
 - Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
 - Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
 - Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality based on institutional standard of care)
 - Presence of brain metastases
 - Lymphadenopathy exceeding 6 cm in short-axis diameter
 - Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
 - Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered.
 - Any other serious illness or medical condition, such as but not limited to:
 -- Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2 
 -- Cardiac failure New York Heart Association (NYHA) III or IV
 -- Crohn’s disease or ulcerative colitis
 -- Bone marrow dysplasia
 - Fecal incontinence

Trial Summary

Enrollment Goal

705

Trial Dates

July2012

February2016

Phase

Could I receive a placebo?

Products

Xofigo (Radium-223 dichloride, BAY88-8223)

Accepts Healthy Volunteers

Where to Participate

Locations

Status

Locations	Status
Locations Investigative Site Berlin, Germany, 12200	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Dresden, Germany, 01307	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Aachen, Germany, 52074	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Frankfurt, Germany, 60590	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site München, Germany, 81377	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site München, Germany, 81675	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Mainz, Germany, 55131	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Rostock, Germany, 18107	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Berlin, Germany, 14197	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Bremen, Germany, 28277	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Erlangen, Germany, 91054	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Magdeburg, Germany, 39120	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Tübingen, Germany, 72076	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Stockholm, Sweden, 171 76	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Jena, Germany, 07740	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Düsseldorf, Germany, 40225	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Lund, Sweden, 221 85	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Uppsala, Sweden, 751 85	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Linköping, Sweden, 581 85	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Umeå, Sweden, 901 85	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kalmar, Sweden, 391 85	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Sundsvall, Sweden, 851 86	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Eskilstuna, Sweden, 633 52	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Karlstad, Sweden, 651 85	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Beer Sheva, Israel, 8410101	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kfar Saba, Israel, 4428164	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Haifa, Israel, 3109601	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Zerifin, Israel, 6093000	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Jerusalem, Israel, 9112001	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Petah Tikva, Israel, 4941492	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Tel Aviv, Israel, 6423906	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Galway, Ireland	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Dublin 6, Ireland	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Cork, Ireland	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Meldola, Italy, 47014	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Milano, Italy, 20133	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Pisa, Italy, 56126	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Lausanne, Switzerland, 1011	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site St. Gallen, Switzerland, 9007	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Chur, Switzerland, 7000	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Aarau, Switzerland, 5001	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Basel, Switzerland, 4056	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Bern, Switzerland, 3010	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Zürich, Switzerland, 8091	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Helsinki, Finland, 00180	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Tampere, Finland, FIN-33520	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site HUS, Finland, 00029	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Seinäjoki, Finland, 60220	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Kuopio, Finland, 70210	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Lørenskog, Norway, 1478	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Bodø, Norway, 8092	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Bergen, Norway, 5021	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Oslo, Norway, 0424	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Ålesund, Norway, 6026	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Plymouth, United Kingdom, PL6 8DH	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Milano, Italy, 20089	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Roma, Italy, 00161	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Messina, Italy, 98125	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Barcelona, Spain, 08035	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Pamplona, Spain, 31008	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Madrid, Spain, 28033	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Santiago de Compostela, Spain, 15706	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Malaga, Spain, 29010	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Madrid, Spain, 28007	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site ZWOLLE, Netherlands, 8025 AB	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site NIJMEGEN, Netherlands, 6525 GA	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Örebro, Sweden, 715 92	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Bebington, United Kingdom, CH63 4JY	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Berlin, Germany, 10719	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Marburg, Germany, 35043	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Freiburg im Breisgau, Germany, 79106	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Nottingham, United Kingdom, NG5 1PB	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Torino, Italy, 10043	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Genova, Italy, 16128	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Ulm, Germany, 89075	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Hamburg, Germany, 20246	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Barcelona, Spain, 08025	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Barcelona, Spain, 08036	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Palma de Mallorca, Spain, 07120	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Madrid, Spain, 28046	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Córdoba, Spain, 14004	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Hospitalet de Llobregat, Spain, 08907	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Manchester, United Kingdom, M20 4BX	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Belfast, United Kingdom, BT9 7AB	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Coventry, United Kingdom, CV2 2DX	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site London, United Kingdom, SE1 9RT	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Guildford, United Kingdom, GU2 7XX	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Warszawa, Poland, 02-781	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Treviso, Italy, 31100	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Arezzo, Italy, 52100	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Trento, Italy, 38122	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Roma, Italy, 00189	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Roma, Italy, 00149	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Toronto, Canada, M5G 2M9	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Vancouver, Canada, V5Z 4E6	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Toronto, Canada, M4N 3M5	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1200	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1000	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site GENT, Belgium, 9000	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site LEUVEN, Belgium, 3000	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1090	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Ramat Gan, Israel, 5262000	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Bialystok, Poland, 15-027	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Santander, Spain, 39008	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Madrid, Spain, 28041	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Sevilla, Spain, 41013	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Oviedo, Spain, 33006	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Valencia, Spain, 46026	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Ottawa, Canada, K1H 8L6	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Montreal, Canada, H2L 4M1	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Obninsk, Russia, 249036	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Moscow, Russia, 115478	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available

Trial Design

Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastases

Trial Type:

Interventional

Intervention Type:

Drug

Trial Purpose:

Treatment

Allocation:

N/A

Blinding:

Open Label

Assignment:

Single Group Assignment

Trial Arms:

Primary Outcome

Acute safety, variables will be summarized using descriptive statistics based on adverse events collection
Safety variables to be analyzed during the treatment period include: ECOG PS, Skeletal-related events, Treatment emergent Grade 3-4 AEs, any grade of treatment-related AEs and SAEs, Safety laboratory tests including hematology and serum chemistry
Timeframe: From baseline to 30 days post-treatment

Long-term safety, variables will be summarized using descriptive statistics based on adverse events collection
Safety variables to be analyzed during the follow-up period include: Skeletal-related events, Treatment related AEs and SAEs, Secondary malignancies
Timeframe: From 30 days post-treatment up to 3 years

Secondary Outcome

Brief Pain Inventory, as assessed by BPI-SF questionnaire (Brief Pain Inventory-Short Form)
Timeframe: From baseline up to 1 year

Prostatic Neoplasms

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

No Limit

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information