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

  • STATUS
    Recruiting
  • End date
    Apr 24, 2022
  • participants needed
    400
  • sponsor
    Clovis Oncology, Inc.
Updated on 24 July 2021
Investigator
Clovis Oncology For North America, Latin America and Asia Pacific inquiries:
Primary Contact
Sunnybrook Odette Cancer Centre (7.2 mi away) Contact
+209 other location

Summary

The purpose of this study is to determine how patients 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.

Details
Condition Metastatic Castration Resistant Prostate Cancer
Treatment rucaparib, Abiraterone acetate or Enzalutamide or Docetaxel
Clinical Study IdentifierNCT02975934
SponsorClovis Oncology, Inc.
Last Modified on24 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
Prior treatment with any PARP inhibitor
Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer
Symptomatic and/or untreated central nervous system metastases
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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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