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 21, 2022
  • participants needed
    400
  • sponsor
    Clovis Oncology, Inc.
Updated on 21 September 2020
Investigator
Clovis Oncology Clinical Trial Information
Primary Contact
Northern Cancer Insitute, St. Leonards (4.8 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
Treatment rucaparib, Abiraterone acetate or Enzalutamide or Docetaxel
Clinical Study IdentifierNCT02975934
SponsorClovis Oncology, Inc.
Last Modified on21 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have Metastatic Castration Resistant Prostate Cancer?
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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Step 4 Get your study results

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