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Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Prostatectomy in Prostate Cancer

NCT07500701 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-03-30

No results posted yet for this study

Summary

This study is the first prospective, randomized phase III clinical trial designed to evaluate whether ultrahypofractionated radiotherapy is non-inferior to conventionally moderately hypofractionated radiotherapy in terms of efficacy, with acceptable toxicity, in patients who develop biochemical recurrence following radical prostatectomy.

Considering the potential clinical benefits of shorter treatment duration, cost reduction, and improved patient convenience, this study is expected to provide important evidence to optimize salvage radiotherapy strategies in routine clinical practice.

Conditions

Interventions

RADIATION

Moderate hypofractionated radiotherapy (Moderate-hypoRT)

Moderate hypofractionated radiotherapy (Moderate-hypoRT): 60 Gy in 24 fractions (administered once daily on weekdays, five times per week, over a total of 5-6 weeks).

RADIATION

Ultra-hypofractionated radiotherapy (Ultra-hypoRT)

Ultra-hypofractionated radiotherapy (Ultra-hypoRT): 31 Gy in 5 fractions (administered every other day, 2-3 times per week, over a total of 2 weeks).

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-06
Primary Completion
2034-12-31
Completion
2034-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

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 NCT07500701 on ClinicalTrials.gov