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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT02849990
Phase
PHASE2
Status
Completed

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abiraterone Acetate — DRUG
    Given PO
  • Apalutamide — DRUG
    Given PO
  • Degarelix — DRUG
    Given SC
  • Indomethacin — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative study
  • Prednisone — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Mar 9, 2017
Status verified
Dec 2021
Primary completion
Dec 10, 2018
Completion
Dec 10, 2020

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (neoadjuvant chemotherapy)
    Patients receive androgen receptor antagonist ARN-509 and abiraterone acetate PO daily, prednisone PO BID and indomethacin PO TID. Patients also receive degarelix 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.

Primary Outcome Measure

Pathologic Complete Response Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment [ Time Frame: At 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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