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

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.

Description

Eligibility

Age range

18+ years

Sex

Male

Healthy volunteers

No

Interventions

• Drug
  Abiraterone Acetate

  Given PO

• Drug
  Antiandrogen Therapy

  Given ADT

• Drug
  Apalutamide

  Given PO

• Procedure
  Biopsy

  Undergo biopsy

• Drug
  Niraparib

  Given PO

• Drug
  Prednisone

  Given PO

• Radiation
  Radiation Therapy

  Undergo radiation therapy

Location