Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy

Part of paid clinical trials in La Jolla, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT02903368
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Apalutamide — DRUG
  • Leuprolide — DRUG
  • Prednisone — DRUG
  • Abiraterone Acetate — DRUG

Study Details

This multicenter randomized phase II trial investigates the impact of intense androgen deprivation on radical prostatectomy (RP) pathologic response and radiographic and tissue biomarkers in localized prostate cancer (NCT02903368).

Key Dates

Start date
Oct 19, 2016
Status verified
Jun 2025
Primary completion
Apr 5, 2022
Completion
Jul 10, 2024

Study Design

Enrollment
118 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1A: AAPL Neoadjuvant Therapy [Part 1]
    Eligible Participants will be randomized to receive: AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months Pts x weeks to RP
  • Experimental: Arm 1B: APL Neoadjuvant Therapy [Part 1]
    Eligible Participants will be randomized to receive: APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
  • Experimental: Arm 2A: AAPL Adjuvant Therapy [Part 2]
    Eligible Participants will be randomized to receive: AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months
  • No Intervention: Arm 2B: Observation [Part 2]

Primary Outcome Measure

Combined pCR or MRD Rate [Part 1] [ Time Frame: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy. ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of California, San Diego Moores Cancer CenterLa JollaCalifornia92093-
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in La Jolla, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California, San Diego Moores Cancer Center· La Jolla, CABeth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MAMemorial Sloan-Kettering Cancer Center· New York, NY

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