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

NCT03503344 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-01-21

Study results available
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Summary

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.

Conditions

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

Interventions

DRUG

Apalutamide

Given PO, 240 mg per day (4 x 60mg tablets)

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

Sponsors & Collaborators

Principal Investigators

  • Rahul Aggarwal, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-17
Primary Completion
2024-12-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03503344 on ClinicalTrials.gov