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

Phase 1

• 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); MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000300-28-SE
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-03
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 382

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 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 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 102
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 238

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.
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