Apalutamide With or Without Stereotactic Body Radiation in Treating Castration-Resistant Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT03503344
Phase
PHASE2
Status
Completed

Conditions

  • Castration Levels of Testosterone
  • Castration-Resistant Prostate Carcinoma
  • PSA Progression
  • Stage IV Prostate Adenocarcinoma AJCC v7

Eligibility Criteria

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

Interventions

  • Apalutamide — DRUG
    Given PO, 240 mg per day (4 x 60mg tablets)
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo SBRT

Study Details

This phase II trial studies the how well apalutamide with or without stereotactic body radiation therapy work in treating participants with castration-resistant prostate cancer. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. It is not yet known whether giving apalutamide with or without stereotactic body radiation therapy works better in treating participants with castration-resistant cancer.

Key Dates

Start date
Dec 17, 2019
Status verified
Jan 2026
Primary completion
Dec 31, 2024
Completion
Oct 31, 2025

Study Design

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

Arms

  • Experimental: Arm A (apalutamide monotherapy)
    Participants receive apalutamide PO QD on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm B (apalutamide, SBRT)
    Participants receive apalutamide PO QD on days 1-28. Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Beginning 60 days after first dose of apalutamide, participants also undergo stereotactic body radiation therapy for 1-5 fractions.

Primary Outcome Measure

Proportion of Participants With Undetectable Serum Prostate-specific Antigen (PSA) [ Time Frame: Approximately 18 months from date of randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94115-

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University of California, San Francisco· San Francisco, CA

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