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

March 23, 2026 updated by: Won Park, Samsung Medical Center

Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Prostatectomy in Prostate Cancer: A Prospective, Multi-Center, Randomized Phase III Non- Inferiority Trial (HUB Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

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

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Gangnam-gu
      • Seoul, Gangnam-gu, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who have undergone radical prostatectomy for prostate cancer
  • Age ≥ 20 years
  • Persistent prostate-specific antigen (PSA) elevation after radical prostatectomy, defined as prostate-specific antigen (PSA) levels of 0.1-1.0 ng/mL with at least three consecutive increases
  • Patients who have undergone prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) for evaluation of prostate-specific antigen (PSA) elevation
  • Good performance status (ECOG performance status 0-1)

Exclusion Criteria:

  • Radiologic or clinical evidence of gross local recurrence, lymph node metastasis, or distant metastasis, including findings on prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT), as determined by the treating physician
  • Presence of lymph node metastasis or distant metastasis at the time of radical prostatectomy
  • History of prior pelvic radiotherapy
  • Diseases associated with a high risk of radiation toxicity (e.g., inflammatory bowel disease, systemic lupus erythematosus, scleroderma, or other connective tissue diseases)
  • History of another malignancy diagnosed or recurrent within the past 3 years (except for skin cancer and thyroid cancer)
  • Uncontrolled acute or chronic conditions deemed inappropriate for study participation by the investigator (e.g., dementia, Alzheimer's disease, cerebral infarction, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Moderate hypofractionated radiotherapy (Moderate-hypoRT)
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).
Experimental: Ultra-hypofractionated radiotherapy (Ultra-hypoRT)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
5-year biochemical progression-free survival (bPFS)
Time Frame: 5 years after treatment completion
5 years after treatment completion

Secondary Outcome Measures

Outcome Measure
Time Frame
Analyze Distant Metastasis-Free Survival (DMFS)
Time Frame: 5 years after treatment completion
5 years after treatment completion
Cancer-Specific Survival (CSS)
Time Frame: 5 years after treatment completion
5 years after treatment completion
Overall Survival (OS)
Time Frame: 5 years after treatment completion
5 years after treatment completion
Compare acute and late Genitourinary (GU) and Gastrointestinal (GI) toxicities.
Time Frame: 5 years after treatment completion
5 years after treatment completion
Compare patient-reported Quality of Life (QoL) outcomes
Time Frame: During treatment and follow-up
During treatment and follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2026

Primary Completion (Estimated)

December 31, 2034

Study Completion (Estimated)

December 31, 2034

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2026-01-079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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