Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations

Sponsor
Qian Qin
Study ID
NCT06392841
Phase
PHASE2
Status
Withdrawn

Conditions

  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation
  • BRIP1 Gene Mutation
  • CHEK2 Gene Mutation
  • Deleterious HRR Gene Mutation
  • FANCA Gene Mutation
  • Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
  • PALB2 Gene Mutation
  • RAD51B Gene Mutation
  • RAD54L Gene Mutation

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Androgen Deprivation Therapy (ADT) — DRUG
    Medical castration per ADT with GnRH agonist or antagonist (or surgical castration per orchiectomy)
  • Niraparib/Abiraterone Acetate DAT — DRUG
    Niraparib 200 mg/ Abiraterone acetate 1000 mg orally
  • Abiraterone Acetate — DRUG
    1000 mg orally
  • Prednisone — DRUG
    5 mg orally
  • Docetaxel — DRUG
    75 mg/m2 IV

Study Details

This is an open label, phase II trial in subjects with treatment naïve, metastatic hormone sensitive prostate cancer (mHSPC) with deleterious homologous recombination repair (HRR) alteration(s). These include pathologic alterations in BRCA 1/2, BRIP1, CHEK2, FANCA, PALB2, RAD51B, and/or RAD54L. A total of 64 people will be enrolled to the study.

Key Dates

Start date
Oct 31, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Initial Treatment (Cycle 1 to Cycle 6)
    Androgen Deprivation Therapy (ADT) with a GnRH agonist or antagonist per standard of care. 200 mg niraparib and 1,000 mg abiraterone acetate dual action tablet (DAT, Akeega) once daily, with 5mg prednisone once daily for 24 weeks (6 cycles) unless there is progression or unacceptable toxicity. After 6 cycles, disease evaluation performed.
  • Experimental: Cohort A: prostate specific antigen (PSA) >4 ng/mL without progression at the completion of 24 weeks
    After 6 cycles, there will be an option to: 1. Continue ADT + niraparib/abiraterone acetate plus prednisone in 28-day cycles for a total of 2 years OR until disease progression or unacceptable toxicity. Subsequent therapy will be at the discretion of the investigator per standard of care. 2. Discontinue niraparib. Continue ADT, start abiraterone acetate plus prednisone and docetaxel 75mg/m2 in 21-day cycles. Docetaxel every 3 weeks x 6 doses. At the completion of docetaxel, the subject will move to follow-up per protocol. Niraparib should not be restarted at the completion of docetaxel. Subsequent therapy will be at the discretion of the investigator per standard of care.
  • Experimental: Cohort B: PSA ≤ 4 ng/mL without progression at the completion of 24 weeks
    Continue ADT + niraparib/abiraterone acetate plus prednisone for 1 year unless progression or unacceptable toxicity. At 1 year, disease evaluation will occur. * PSA ≥ 0.2 ng/mL: ADT + niraparib/abiraterone acetate plus prednisone will continue for 2 years or until progression or unacceptable toxicity. Therapy beyond 2 years will be per standard of care per investigator discretion. * PSA \< 0.2 ng/mL and PSA not trending up: 1. Continue ADT + niraparib/abiraterone acetate plus prednisone for 2 years or until progression or unacceptable toxicity. Therapy beyond 2 years will be per standard of care per investigator discretion OR 2. STOP ADT + niraparib/abiraterone acetate plus prednisone only IF: * C14 PSA \< 0.2 AND not trending up * Subjects not eligible that elect to stop ADT + niraparib/abiraterone acetate plus prednisone, will be removed from protocol treatment and move to follow-up. Subsequent therapy re-initiation will be at the discretion per standard of care.

Primary Outcome Measure

Rate of participants with PSA decline to < 0.2 ng/ml [ Time Frame: 24 weeks ]

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