RecruitingPhase 2NCT04947254

Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer

Phase II Trial of Primary Radiotherapy With Androgen Ablation With or Without Adjuvant Niraparib for Selected High-Risk Locoregional Prostate Cancer


Sponsor

M.D. Anderson Cancer Center

Enrollment

200 participants

Start Date

Aug 5, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called niraparib (a PARP inhibitor that helps block cancer cell DNA repair) to standard hormone-blocking therapy (androgen deprivation therapy) improves outcomes for men with high-risk prostate cancer who are being treated with radiation. **You may be eligible if...** - You are male, 18 or older - You have high-risk localized or locally advanced prostate cancer (e.g., PSA over 20, aggressive tumor grade, or locally spread disease) - You are planned to receive radiation and hormone-blocking therapy as your primary treatment - You have not had prior surgery or radiation for prostate cancer - Your blood counts and organ function are within acceptable limits **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have previously used a PARP inhibitor or had systemic prostate cancer treatment (other than hormone therapy started within 6 months) - You have a history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) - You have had a heart attack, stroke, or serious heart problems within 6 months - You have seizures or conditions that increase seizure risk - You are unable to swallow tablets - You have significant uncontrolled medical or psychiatric conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbiraterone Acetate

Given PO

DRUGAntiandrogen Therapy

Given ADT

DRUGApalutamide

Given PO

PROCEDUREBiopsy

Undergo biopsy

DRUGNiraparib

Given PO

DRUGPrednisone

Given PO

RADIATIONRadiation Therapy

Undergo radiation therapy


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04947254


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