NCT02849990

A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy

A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-Prostatectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin work in treating patients with prostate cancer that has spread from where it started to nearby tissue or lymph nodes before surgery. Androgen can cause the growth of tumor cells. Hormone therapy using apalutamide, abiraterone acetate, prednisone, degarelix, and indomethacin may fight prostate cancer by lowering the amount of androgen the body makes and/or blocking the use of androgen by the tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. The rate of the pathologic complete response (pCR) (i.e. no evidence of residual tumor) as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin. SECONDARY OBJECTIVES: I. To determine the negative margin rate as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin. II. To determine the rate of near pCR (i.e. =\< 5 mm of residual tumor) as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin. III. To determine the rate of pathologic T3 disease as assessed on prostatectomy specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin. IV. To determine the rate of nodal metastases as assessed on surgical lymph node specimens following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin. V. To determine the apoptotic index (i.e. percentage of tumor cells undergoing apoptosis) as determined by cleaved caspase-3 immunohistochemistry following 3-months (12 weeks) of neoadjuvant apalutamide, abiraterone acetate, degarelix and indomethacin. VI. To determine the proportion of men who receive adjuvant radiation therapy within 1-year of prostatectomy. VII. To determine the biochemical (i.e. prostate-specific antigen \[PSA\]) progression free survival estimate two years after the last patient has accrued (i.e. confirmed PSA post-radical prostatectomy \>= 0.2 ng/mL). VIII. To determine the overall survival estimate two years after the last patient has accrued. IX. Safety as assessed by the incidence and severity of adverse events and serious adverse events graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. X. Exploratory biomarker assessment. OUTLINE: Patients receive apalutamide and abiraterone acetate orally (PO) daily, prednisone PO twice per day (BID) and indomethacin PO three times per day (TID). Patients also receive degarelix subcutaneously (SC) on day 1 and every 4 weeks for 3 doses. Treatment continues for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy on day 85. After completion of study treatment, patients are followed up at 28, 113, 450 and 815 days.

Conditions

• Stage III Prostate Adenocarcinoma AJCC v7
• Stage III Prostate Cancer AJCC v7
• Stage IV Prostate Adenocarcinoma AJCC v7
• Stage IV Prostate Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	Given PO
DRUG	Apalutamide	Given PO
DRUG	Degarelix	Given SC
DRUG	Indomethacin	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative study
DRUG	Prednisone	Given PO

Timeline

• Start date: 2017-03-09
• Primary completion: 2018-12-10
• Completion: 2020-12-10
• First posted: 2016-07-29
• Last updated: 2022-01-13
• Results posted: 2020-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study