Actively Recruiting
Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-02-19
200
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial studies the effect of androgen ablation therapy with or without niraparib after standard of care radiation therapy in treating patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Androgen ablation therapy (also known as hormone therapy) lowers the levels of male hormones called androgens in the body. Androgens stimulate prostate cancer cells to grow. There are 2 types of androgen ablation therapy given in this study: AAP + ADT and Apa + ADT. AAP + ADT is the treatment combination of the drugs abiraterone acetate and prednisone (AAP) given with androgen deprivation therapy (ADT, also known as androgen deprivation therapy or androgen suppression medication, which is used as standard of care to lower testosterone levels in men with high risk localized or metastatic prostate cancer). Apa + ADT is the treatment combination of the drug apalutamide (Apa) given with ADT. Androgen ablation therapy with or without niraparib after radiation therapy may help to control the disease in patients with prostate cancer.
CONDITIONS
Official 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...
- Male aged 18 years and above
- Histologically or cytologically confirmed prostate carcinoma
- Localized or regional high-risk disease defined by at least one: PSA > 20 ng/mL, T3a or higher, grade group 4-5 (Gleason score 65 8), or positive regional lymph nodes
- Planned definitive treatment with radiation therapy and androgen ablation
- Willing to maintain testosterone levels 64 50 ng/dL through medical castration or have had bilateral orchiectomy
- ECOG performance status 64 2
- Adequate organ and bone marrow function within 7 days prior to registration, including hemoglobin 65 10.0 g/dL, ANC 65 1.5 x 10^9/L, WBC > 3 x 10^9/L, platelets 65 100 x 10^9/L, total bilirubin 64 1.5 x ULN (with exceptions for Gilbert's disease), AST and ALT 64 2.5 x ULN, creatinine clearance 65 30 mL/min, serum albumin 65 3.0, serum potassium 65 3.5 mmol/L
- Able to swallow study drugs whole
- Willing to use two methods of birth control if having partners of childbearing potential during study and for 4 months after last dose
- Able and willing to comply with protocol including treatments, visits, and follow-up
- Medications lowering seizure threshold must be stopped or substituted at least 4 weeks before entry
You will not qualify if you...
- Prior systemic treatment for prostate cancer except ADT started within 6 months before enrollment
- Prior PARP inhibitor therapy
- Prostate cancer with distant metastasis
- Prior major prostate surgery or radiotherapy
- Unresolved toxicity of grade 2 or higher from previous anti-cancer therapies
- History or current diagnosis of myelodysplastic syndrome or acute myeloid leukemia
- History of other malignancies with high risk of recurrence within 24 months (except certain treated skin and cervical cancers)
- Active uncontrolled infections
- Active or symptomatic viral hepatitis or chronic liver disease
- Active pneumonitis or extensive bilateral lung disease
- Medical or psychiatric conditions that could interfere with treatment or safety
- Unable to swallow oral medication or have gastrointestinal issues affecting absorption
- Known hypersensitivity to niraparib, apalutamide, or abiraterone acetate
- Prisoners or involuntarily incarcerated individuals
- History or risk of seizures or certain brain conditions
- Severe or unstable heart conditions or recent serious cardiovascular events
- Conditions such as gastrointestinal absorption issues, active infections like HIV, chronic high-dose corticosteroid use, and certain liver impairments
- Use of strong CYP3A4 inducers during abiraterone treatment unless dosing adjusted
- Use of narrow therapeutic index CYP2D6 substrates without caution
- Any condition deemed by investigator to preclude study participation
AI-Screening
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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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