Study of Olaparib (Lynparza¿) Versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

Phase 1

Active, not recruiting

• Conditions: metastatic castration-resistant prostate cancer; MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000300-28-IT
• Lead Sponsor: ASTRAZENECA SPA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-25
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Male
• Target Recruitment: 340

Inclusion Criteria

1. Histologically confirmed diagnosis of prostate cancer.
2. Candidate for treatment with enzalutamide or abiraterone with
documented evidence of mCRPC.
3. Subjects must have progressed on prior new hormonal agent (e.g.
abiraterone acetate and/or enzalutamide) for the treatment of mCRPC.
4. Ongoing therapy with LHRH analog or bilateral orchiectomy.
5. Radiographic progression at study entry while on androgen
deprivation therapy (or after bilateral orchiectomy).
6. Qualifying HRR mutation in tumor tissue by the Lynparza HRR Assay
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Any previous treatment with PARP inhibitor, including olaparib
2. Subjects who have any previous treatment with DNA-damaging
cytotoxic chemotherapy.
3. 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.
4. Subjects with myelodysplastic syndrome/acute myeloid leukemia or
with features suggestive of MDS/AML.
5. *Subjects with known brain metastases.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy (as assessed by rPFS) of olaparib versus<br>investigator choice of enzalutamide or abiraterone acetate in men with<br>mCRPC with BRCA1, BRCA2 or ATM qualifying mutations (Cohort A);Secondary Objective: to determine the efficacy of olaparib versus investigator choice of enzalutamide or abiraterone acetate in subjects with HRR qualifying gene mutattions measured by objective response rate in Cohort A, rPFS in Cohort A+B, time to pain progression in Cohort A and overall survivall in Cohort A;Primary end point(s): Radiological Progression free survival (rPFS) by blinded independent central review (BICR) using RECIST 1.1. (soft tissue) and PCWG3 (bone) criteria;Timepoint(s) of evaluation of this end point: At baseline and every 8 weeks (± 7 days), relative to the date of randomization, until objective radiological disease progression by BICR using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria