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A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery

NCT03809000 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2025-12-30

Study results available
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Summary

Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.

Conditions

Interventions

RADIATION

Radiation Therapy

daily fractions

DRUG

Enzalutamide

tablet

DRUG

Bicalutamide

tablet

DRUG

GnRH analog

Injection

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • RTOG Foundation, Inc.

    lead OTHER

Principal Investigators

  • Edwin Posadas, MD · RTOG Foundation

  • Hiram Gay, MD · RTOG Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2023-04-07
Completion
2029-09-15
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT03809000 on ClinicalTrials.gov