Phase 3
Completed N=387
Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)
Source: ClinicalTrials.gov NCT02987543 ↗Enrolled (actual)
387
Serious AEs
34.5%
Results posted
Oct 2020
Primary outcomePrimary: Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only — 7.39; 3.55 Months — p=<0.0001
◆ Published Evidence
Established
91citations · ~46 / year
Olaparib for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer and Alterations in <i>BRCA1</i> and/or <i>BRCA2</i> in the PROfound Trial.
Summary
The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.
Linked Publications (5)
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Olaparib for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer and Alterations in <i>BRCA1</i> and/or <i>BRCA2</i> in the PROfound Trial.
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Pain and health-related quality of life with olaparib versus physician's choice of next-generation hormonal drug in patients with metastatic castration-resistant prostate cancer with homologous recombination repair gene alterations (PROfound): an open-label, randomised, phase 3 trial.
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Olaparib tolerability and common adverse-event management in patients with metastatic castration-resistant prostate cancer: Further analyses from the PROfound study.
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Olaparib in patients with mCRPC with homologous recombination repair gene alterations: PROfound Asian subset analysis.
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Update on Liquid Biopsy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only |
7.39; 3.55 | <0.0001 sig |
| SECONDARY Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) - Cohort A Only |
28; 1; 56; 42 | <0.0001 sig |
| SECONDARY Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A+B |
5.82; 3.52 | <0.0001 sig |
| SECONDARY Time to Pain Progression - Cohort A Only |
NA; 9.92 | 0.0192 sig |
| SECONDARY Overall Survival (OS) - Cohort A Only |
91; 57; 49; 21; 22; 5 | 0.0175 sig |
Eligibility 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 metastatic prostate cancer and/or CRPC .
- 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
- Any previous treatment with PARP inhibitor, including olaparib.
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02987543) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.