Apalutamide and Leuprolide in Intermediate and High-risk Prostate Cancer

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT02770391
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Leuprolide acetate — DRUG
    Leuprolide acetate, Intramuscular injection - 7.5 mg, one time dose on day (-28) ± 3
  • Apalutamide — DRUG
    Apalutamide, PO, 240 mg daily, starting day (-28) ± 3 until the day before radical prostatectomy. Apalutamide will be initiated the same day patients receive their leuprolide acetate injection.
  • Radical prostatectomy — PROCEDURE

Study Details

This is a research study to test an investigational drug (Not FDA approved), Apalutamide given in combination with Leuprolide acetate (FDA approved) in men diagnosed with high-risk prostate cancer who have already selected to have surgery to remove their prostate gland as part of their treatment plan. The main purpose of this study is to determine how tumors make androgens (male hormones), which makes these tumors more aggressive and resistant to hormonal therapy and how a short period of treatment with Apalutamide and leuprolide acetate prior to surgery can affect the production of these hormones in normal and malignant prostate tissue.

Key Dates

Start date
Oct 17, 2016
Status verified
May 2022
Primary completion
Apr 29, 2020
Completion
Apr 29, 2020

Study Design

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

Arms

  • Experimental: Apalutamide + Leuprolide Acetate
    All participating patients will receive a single dose of leuprolide 7.5 mg intramuscularly (IM) in addition to Apalutamide 240 mg orally daily for four weeks prior to radical prostatectomy (RP). Treatment will be started on day (-28) ± 3 from the scheduled RP date to minimize the variability of treatment duration. Apalutamide may be continued up to and including the day before

Primary Outcome Measure

Dihydrotestosterone (DHT) Concentration in Benign Prostate Tissue After a Combination Drug Treatment Based on Genotype Status [ Time Frame: Up to 28 Days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic, Case Comprehensive Cancer CenterClevelandOhio44195-

Find similar trials in Cleveland, OH

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Cleveland Clinic, Case Comprehensive Cancer Center· Cleveland, OH

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