Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men with Metastatic Castration-resistant Prostate Cancer.

Phase 3

Completed

Conditions: metastatic castration resistant prostate cancer
prostate cancer
10036958

Registration Number: NL-OMON45999

Lead Sponsor: Astra Zeneca

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

- Histologically or cytologically confirmed prostate adenocarcinoma
- Metastatic status defined as at least 1 documented metastatic lesion on either a bone scan
or a CT/MRI scan.
- First-line metastatic castration resistant prostate cancer (mCRPC) (treatment naïve at mCRPC stage)
- Ongoing androgen deprivation with gonadotropin-releasing hormone analogue or bilateral
orchiectomy, with serum testosterone <50 ng/dL (<2.0 nmol/L) within 28 days before
randomisation.

Exclusion Criteria

- Known additional malignancy that has had progression or has required active
treatment in the last 5 years. Exceptions include basal cell carcinoma of the skin, and
squamous cell carcinoma of the skin that has undergone potentially curative therapy
- Patients with myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML
- Patients with brain metastases
- Clinically significant cardiovascular disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective: to determine the efficacy of the combination of olaparib and<br /><br>abiraterone vs placebo and abiraterone by assessment of rPFS (Radiographic<br /><br>progression-free survival) in patients with mCRPC (Metastatic<br /><br>castration-resistant prostate cancer) who have received no prior cytotoxic<br /><br>chemotherapy or NHA (New hormonal agent (abiraterone, enzalutamide)) at mCRPC<br /><br>stage.<br /><br><br /><br>outcome: rPFS, defined as the time from randomisation to:<br /><br>1) radiographic progression, assessed by investigator per RECIST 1.1 (soft<br /><br>tissue) and PCWG-3 criteria (bone), or<br /><br>2) death from any cause, whichever occurs first.</p><br>

Secondary Outcome Measures