PROfound

A Phase 3, 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223497

Enrollment

Registered

2017-03-31

Start date

2017-04-07

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

investigational material(s) Generic name etc : olaparib INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
efficacy -	—

Secondary

Measure	Time frame
safety efficacy -	—

Countries

Asia except Japan, Europe, Japan, North America

Contacts

Public ContactKazushige Hibi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-648023533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026