Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03412396
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Prostate Adenocarcinoma
  • Stage IIB Prostate Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Apalutamide — DRUG
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Radical Prostatectomy — PROCEDURE
    Undergo radical prostatectomy

Study Details

This phase II trial studies how well apalutamide works in treating patients with prostate cancer before radical prostatectomy. Androgen can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by lowering the amount of androgen the body makes and may make it less likely for patients to receive radiation therapy after surgery.

Key Dates

Start date
Mar 22, 2018
Status verified
Mar 2026
Primary completion
Oct 3, 2024
Completion
Mar 30, 2026

Study Design

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

Arms

  • Experimental: Treatment (apalutamide, radical prostatectomy)
    Patients receive apalutamide PO daily for 24 weeks in the absence of disease progression or unacceptable toxicity. Within 2 weeks of completing apalutamide, patients undergo radical prostatectomy.

Primary Outcome Measure

Number of Adverse Surgical Pathology Features at Risk of Pelvic Radiation Therapy [ Time Frame: Assessed at time of surgical specimen microscopic evalution Assessed at time of surgical specimen microscopic evaluation ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

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