A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

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About the study

The purpose of this study is to determine how participants with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Be 18 years old at the time the informed consent is signed
  2. Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic
  3. Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
  4. Be eligible for treatment with physician's choice of comparator treatment (abiraterone acetate, enzalutamide or docetaxel)
  5. Experienced disease progression after having received 1 prior next generation androgen receptor-targeted therapy
  6. Have a deleterious mutation in a BRCA1/2 or ATM gene

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
  2. Prior treatment with any PARP inhibitor
  3. Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer
  4. Symptomatic and/or untreated central nervous system metastases
  5. Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of study drug

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition
Metastatic Castration Resistant Prostate Cancer
Age (in years)
18+
Phase
Phase 3
Participants needed
405
Est. Completion Date
Mar 31, 2024
Treatment type
Interventional

Sponsor
pharmaand GmbH
ClinicalTrials.gov identifier
NCT02975934
Study number
CO-338-063

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