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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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 criteria

Qualifiers

Completion of informed consent prior to any study specific procedures. Consent may be done remotely.

Patients must agree to tissue collection for correlative studies at the specified timepoints

Male aged 18 years and above

Histologically or cytologically confirmed prostate carcinoma

Disqualifiers

Any prior systemic treatment for prostate cancer with the exception of ADT started within 6 months of trial enrollment. Any prior PARP inhibitor therapy

Patients who have prostate cancer with distant metastatic disease

Patients who have had prior major surgery (prostatectomy) or radiotherapy for the treatment of prostate cancer

Any unresolved toxicity (Common Terminology Criteria for Adverse Events [CTCAE] grade ≥ 2) from previous anti-cancer therapies

Trial design

Treatments tested in this trial

  • Abiraterone Acetate
  • Antiandrogen Therapy
  • Apalutamide
  • Biopsy
  • Niraparib
  • Prednisone
  • Radiation Therapy

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators