PROfound

Phase 3

Completed

• Conditions: Metastatic Castration-resistant Prostate Cancer

• Registration Number: JPRN-jRCT2080223497
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: Male
• Target Recruitment: 63

Inclusion Criteria

1. Histologically confirmed diagnosis of prostate cancer

2. Documented evidence of metastatic castration resistant prostate cancer (mCRPC)

3. Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC

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

Exclusion Criteria

1. Any previous treatment with PARP inhibitor, including olaparib

2. Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose > 5 years prior to randomization

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 or more

4. Subjects with known brain metastases

Study & Design

• Study Type: Interventional
• Study Design: Not specified