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

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 - PROfound

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45674

Enrollment

Registered

2016-12-20

Start date

2017-05-02

Completion date

Unknown

Last updated

2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Castration resistant prostate cancer prostate cancer

Interventions

Treatment with Olaparib 300 mg bid or Enzalutamide 160 mg orally od or Abiraterone acetate 1000 mg od with 5 mg bid prednisone.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To determine the efficacy (as assessed by rPFS) of olaparib versus investigator choice of enzalutamide or abiraterone acetate in subjects with mCRPC with BRCA1, BRCA2 or ATM qualifying mutations (Cohort A)	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Sep 19, 2026