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NCT Number: NCT05457257

Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations

The purpose of this study is to evaluate the efficacy and safety of Olaparib compared with standard of care (Enzalutamide or Abiraterone Acetate) in Chinese men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have BRCA1/2 mutations.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Beijing, China

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About this study

This is a Phase IV, randomized, open-label, 2-arm, multicenter study evaluating the efficacy and safety of olaparib in Chinese men with metastatic castration-resistant prostate cancer (mCRPC) who have failed prior treatment with a new hormonal agent (NHA) and have BRCA1/2 mutations. Approximately 42 subjects will be randomized in a 2:1 ratio to olaparib or to investigator's choice of NHA (enzalutamide or abiraterone acetate).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Radiological progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
  • Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue.
  • Normal organ and bone marrow function measured within 28 days prior to administration of study treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.

Exclusion criteria

：

  • Any previous treatment with a poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor, including olaparib.
  • Subjects who had any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose > 5 years prior to randomization.
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease for ≥5 years before the first dose of study intervention and of low potential risk for recurrence.
  • Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.

Treatment and study plan

Olaparib

Drug

300 mg (2x 150 mg tablets) twice daily

Other names: Lynparza

Enzalutamide

Drug

160 mg (4 x 40 mg capsules) once daily

Other names: XTANDI

Abiraterone Acetate

Drug

1,000 mg (4 x 250 mg tablets) once daily

Other names: ZYTIGA

Prednisone

Drug

5mg(5mg x 1 tablet) twice daily

Primary outcomes

  1. Radiological Progression-free Survival - Based on Blinded Independent Central Review (BICR)

    Time frame: Tumor assessments every 8 weeks (± 1 week) relative to the date of randomization until radiological progression as assessed by BICR or death (median duration of treatment of 9 and 6 months for Olaparib and Investigators Choice of NHA respectively).

    rPFS is defined as the time from randomization until the date of objective disease progression (soft tissue or bone) or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.

Secondary outcomes

  1. Confirmed Objective Response Rate (ORR), Based on Blinded Independent Review (BICR)

    Time frame: Tumor assessments every 8 weeks (± 1 week) from randomisation until radiographic progression assessed by BICR (median duration of treatment of 9 and 6 months for Olaparib and Investigators Choice of NHA respectively).

    Confirmed ORR is the percentage of patients with a Complete response (CR) or Partial response (PR), in their soft tissue disease per (RECIST v1.1), in the absence of progression on bone scan per Prostate Cancer Working Group 3 (PCWG3), confirmed >=4 weeks later. Per RECIST v1.1, CR=Disappearance of all target lesions; PR = >=30% decrease in the sum of diameters of target lesions. For each treatment group, confirmed ORR is the number of patients with a confirmed CR or PR divided by the number of patients in the treatment group.

  2. Overall Survival

    Time frame: From the time from the date of randomization until death due to any cause. Assessments continue up to 27 months after the first patient was randomized.

    OS is the time from the date of randomization until death due to any cause.

  3. Time to First Symptomatic Skeletal-related Event

    Time frame: Time from randomization to the first SSRE-radiation for skeletal symptoms, confirmed pathological fracture, confirmed spinal cord compression, or orthopaedic surgery for bone metastases. Assessments continue up to 27 months post first patient enrolled.

    Time from first dose to the first symptomatic skeletal-related event

  4. Time to Opiate Use for Cancer-related Pain

    Time frame: Opioid use will be recorded at baseline and at every study visit, including the safety follow-up visit. Assessments continue up to 27 months post first patient enrolled.

    Time from randomization to opiate use for cancer-related pain

  5. Prostate-specific Antigen Response

    Time frame: Blood samples for PSA assessment will be collected at baseline and every 4 weeks throughout the treatment phase, including at the study treatment discontinuation visit. Assessments continue up to 27 months post first patient enrolled.

    Proportion of participants achieving a ≥50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later (PSA50 response)

  6. Prostate-specific Antigen Response

    Time frame: Blood samples for PSA assessment will be collected at baseline and every 4 weeks throughout the treatment phase, including at the study treatment discontinuation visit. Assessments continue up to 27 months post first patient enrolled.

    Best percentage change from baseline in PSA is defined as the biggest reduction in PSA level compared with baseline (or the smallest increase in the absence of a reduction) taking account of all PSA values collected for each patient.

  7. Time From Randomization to Second Progression or Death

    Time frame: Tumor assessments will be performed every 8 weeks (±7 days) after randomization until radiologic progression or death, unless the participant withdraws consent. Assessments continue up to 27 months post first patient enrolled.

    Time from randomization to second progression by investigator assessment of radiological or clinical progression or death (PFS2)

  8. Subsequent Anticancer Therapy

    Time frame: Recorded from post discontinuation of study treatment up to primary data cut off date. Assessments continue up to 27 months post first patient enrolled.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Foundation Medicine
  • Merck Sharp & Dohme LLC
  • Myriad Genetics, Inc.

Registry information

Official study title

A Randomized, Open-label Study to Assess the Efficacy and Safety of Olaparib Versus Enzalutamide or Abiraterone Acetate in Chinese Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations (PROfound-CN)

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Jul 13, 2022
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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