A phase III, open label, randomized study to assess the efficacy and safety of Olaparib (Lynparza*)versus Enzalutamide or Abiraterone acetate in men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations

Phase 3

Completed

Conditions: Castration resistant prostate cancer
prostate cancer
10036958

Registration Number: NL-OMON45674

Lead Sponsor: Astra Zeneca

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

- Histologically confirmed diagnosis of prostate cancer
- Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
- Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of mCRPC.
- Ongoing therapy with LHRH analog or bilateral orchiectomy.
- Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
- Qualifying HRR mutation in tumor tissue.

Exclusion Criteria

- Any previous treatment with PARP inhibitor, including olaparib
- Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy (prior taxane chemotherapy allowed)
- Other malignancy (including MDS and MGUS) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for >=5 years
- Subjects with known brain metastases

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the efficacy (as assessed by rPFS) of olaparib versus investigator<br /><br>choice of enzalutamide or abiraterone acetate in subjects with mCRPC with<br /><br>BRCA1, BRCA2 or ATM qualifying mutations (Cohort A)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-To determine the efficacy (as assessed by ORR) of olaparib versus investigator<br /><br>choice of enzalutamide or abiraterone acetate in subjects with BRCA1, BRCA2 or<br /><br>ATM qualifying gene mutations (Cohort A)<br /><br>- To determine the efficacy (as assessed by rPFS) of olaparib versus<br /><br>investigator choice of enzalutamide or abiraterone acetate in subjects with HRR<br /><br>qualifying mutations (Cohort A+B).<br /><br>- To determine the efficacy (as assessed by time to pain progression) of<br /><br>olaparib versus investigator choice of enzalutamide or abiraterone acetate in<br /><br>subjects with BRCA1, BRCA2 or ATM qualifying gene mutations (Cohort A)<br /><br>- To determine the efficacy (as assessed by overall survival) of olaparib<br /><br>versus investigator choice of enzalutamide or abiraterone acetate<br /><br>in subjects with BRCA1, BRCA2 or ATM qualifying gene mutations (Cohort A)</p><br>