Actively Recruiting
Phase II Trial of Radiotherapy With Androgen Ablation With or Without Niraparib for High-Risk Localized or Locally Advanced Prostate Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-05-15
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating androgen ablation therapy with or without the drug niraparib after radiation therapy in men with high-risk localized or locally advanced prostate cancer. This phase II trial focuses on men whose cancer has not spread far but may involve nearby tissues or lymph nodes. The goal is to determine if adding niraparib to standard hormone therapy improves disease control and survival outcomes. Participants initially receive apalutamide combined with androgen deprivation therapy (ADT) for up to three 28-day cycles (neoadjuvant phase). This is followed by radiation therapy plus continued apalutamide and ADT for another three cycles (radiation phase). Depending on their response, patients then enter an adjuvant phase where those with a favorable response continue apalutamide and ADT, while those with an unfavorable response are randomized to receive either apalutamide plus ADT alone or abiraterone acetate, prednisone, ADT, and niraparib for up to twelve 28-day cycles. During the study, patients undergo regular assessments including biopsies and laboratory tests to monitor treatment effects and side effects. Researchers measure progression-free survival using imaging and PSA tests over three years, as well as overall survival and safety. After treatment, participants have follow-up visits within weeks and then every three months for three years to track disease status and health.
CONDITIONS
Brief Title
Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent before any study procedures
- Agreed to tissue collection for correlative studies
- Male aged 18 years or older
- Histologically or cytologically confirmed prostate carcinoma
- Localized or regional high-risk disease with PSA > 20 ng/mL, T3a or higher, or grade group 4-5 (Gleason score ≥ 8), or positive regional lymph nodes
- Planned for definitive radiation therapy and androgen ablation
- Willing to maintain testosterone levels ≤ 50 ng/dL throughout treatment or have had bilateral orchiectomy
- ECOG performance status ≤ 2
- Adequate organ and bone marrow function including hemoglobin ≥ 10.0 g/dL, ANC ≥ 1.5 x 10^9/L, WBC > 3 x 10^9/L, platelets ≥ 100 x 10^9/L
- Total bilirubin ≤ 1.5 x institutional upper limit of normal or acceptable for Gilbert's syndrome
- AST and ALT ≤ 2.5 x institutional upper limit of normal
- Creatinine clearance ≥ 30 mL/min
- Serum albumin ≥ 3.0
- Serum potassium ≥ 3.5 mmol/L
- Able to swallow study drugs whole
- Men with partners of childbearing potential agree to use two methods of birth control during and for 4 months after study drugs
- Willing and able to follow study protocol including treatment and visits
- Medications lowering seizure threshold discontinued or substituted at least 4 weeks before study entry
You will not qualify if you...
- Prior systemic prostate cancer treatment except ADT started within 6 months before enrollment or prior PARP inhibitor therapy
- Prostate cancer with distant metastasis
- Prior major prostate surgery or radiotherapy for prostate cancer
- Unresolved toxicity grade ≥ 2 from prior anticancer therapies
- History or current MDS/AML or other malignancy with ≥ 30% recurrence risk within 24 months (except certain treated cancers)
- Active uncontrolled infection
- Active or symptomatic viral hepatitis or chronic liver disease
- Active pneumonitis or extensive bilateral non-malignant lung disease
- Medical or psychiatric conditions making study participation hazardous or interpretation of adverse events difficult
- Unable to swallow oral medication or gastrointestinal disorders affecting absorption
- Known allergy to niraparib, apalutamide, or abiraterone acetate
- Prisoners or involuntarily incarcerated individuals
- Compulsorily detained for psychiatric or physical illness
- Seizure disorders or conditions predisposing to seizures
- Severe or unstable heart conditions within 6 months prior to randomization
- Gastrointestinal disorders affecting absorption
- Use of strong CYP3A4 inducers or narrow therapeutic index CYP2D6 substrates without adjustments
- Moderate or severe hepatic impairment (Child-Pugh B or C)
- Any condition judged by the investigator to preclude study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive daily oral apalutamide and physician's choice androgen deprivation therapy (ADT) for up to 3 cycles, each cycle lasting 28 days, in the absence of disease progression or unacceptable toxicity.
3 visits (one per 28-day cycle)
Duration - Up to 12 weeks
Within 30 days of completing the neoadjuvant phase, participants undergo radiation therapy while continuing daily oral apalutamide and physician's choice ADT for up to 3 cycles.
3 visits (one per 28-day cycle) plus radiation therapy sessions
Duration - Up to 12 months
After radiation therapy, participants with favorable response continue daily oral apalutamide and ADT for up to 12 cycles. Participants with unfavorable response are randomized to either continue apalutamide and ADT or receive abiraterone acetate, prednisone, ADT, and niraparib daily for up to 12 cycles.
Up to 12 visits (one per 28-day cycle)
Duration - Up to 3 years
Participants are monitored after completing study treatment with visits within 14 days, at 30-90 days, and then every 3 months for up to 3 years to assess safety and disease progression.
Visits at 14 days, 30-90 days, then every 3 months
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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