Trials / Recruiting

RecruitingNCT04947254

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

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 200 (estimated)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: Male
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Determine the efficacy of addition of adjuvant niraparib to maximal androgen signaling ablation (AAP + ADT) versus maximal androgen signaling ablation alone (Apa + ADT) following definitive radiation therapy (XRT) for biomarker-selected men with poor histopathologic response to neoadjuvant androgen signaling ablative therapy. SECONDARY OBJECTIVES: I. Determine the safety and tolerability of adjuvant niraparib with androgen ablation versus androgen ablation alone following definitive XRT in the study population. II. Determine the impact of the addition of adjuvant niraparib to maximal androgen signaling ablation (AAP + ADT) versus maximal androgen signaling ablation alone (Apa + ADT) following definitive XRT for biomarker-selected men with good and poor histopathologic response to neoadjuvant androgen signaling ablative therapy on overall survival III. Determine the impact of the niraparib + AAP + ADT and Apa+ADT treatment on eugonadal (non-castrate levels of testosterone) progression free survival. IV. Determine the impact of favorable versus unfavorable histologic response on progression-free survival (PFS) in men who received maximal androgen signaling ablation prior to definitive radiation. CORRELATIVE OBJECTIVE: I. Collect and archive solid and liquid tumor samples, as well as normal blood samples for germline deoxyribonucleic acid (DNA), immune, and metabolic profiles from all study patients for later hypothesis generating associations. Assess the relationship of histopathologic score with circulating markers and clinical outcomes of progression free survival for biomarker discovery. OUTLINE: PART 1 NEOADJUVANT PHASE (CYCLES 1-3): Patients receive apalutamide orally (PO) once daily (QD) on days 1-28, and physician's choice ADT. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. PART 2 RADIATION PHASE (CYCLES 4-6): Within 30 days of completing Part 1, patients undergo radiation therapy. Patients also receive apalutamide PO QD on days 1-28 and physician's choice ADT. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. PART 3 ADJUVANT PHASE (CYCLES 7 AND BEYOND): Patients with favorable response after Part 2 continue Apa + ADT. Patients with unfavorable response after Part 2 are randomized to 1 of 2 groups. GROUP A: Patients receive apalutamide PO QD on days 1-28 and physician's choice ADT. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. GROUP B: Patients receive abiraterone acetate PO QD, prednisone PO twice daily (BID), physician's choice ADT, and niraparib PO QD. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up within 14 days, at 30-90 days, and then every 3 months for 3 years.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2021-08-05
Primary completion: 2026-06-07
Completion: 2026-06-07
First posted: 2021-07-01
Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04947254. Inclusion in this directory is not an endorsement.