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: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10076506 Term: Castration-resistant prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• 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 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.
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