West Cancer Center

PROSTATE: METASTATIC: CASTRATE RESISTANT: DNA-Repair mutation: \"PROfound\"

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)

Title

AstraZeneca D081DC00007- PROfound

Study Title

Site Link

NCT02987543

Malignancy

Prostate cancer

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd or 3rd (Following failure of one anti-androgen)

Investigational Agent

Olaparib

Drug Class

PARP inihibitor

Dan Vaena, MD

Sponsor

AstraZeneca

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Metastatic castration resistant prostate cancer
Progression on abiraterone or enzalutamide but not both
Prior anti-cancer therapy (e.g. docetaxel) permitted but not required
Ongoing therapy with LHRH analog or orchiectomy
Qualifying HRR mutation in tumor tissue (see path tab for full complement of qualifying mutations)
No prior treatment with PARP inhibitor
No prior treatment with platimum or mitoxantrone
No known brain metastases
No other malignancy within 5 years

Objective

Primary: Radiographic PFS: Secondary- ORR, OS, Time to Pain Progression, Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Homologous recombination repair deficiency gene mutations: BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L

Dosing Frequency

Control Agents

Enzalutamide or Abiraterone

Study Protocol

Randomized

Yes