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Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 20 and up Men only

Short-course versus moderate-course salvage radiation for rising PSA after prostate removal

Official title: 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)

Run by Samsung Medical Center · NCT07500701 · Data updated 2026-11-12

This trial will test whether a very short course of salvage radiotherapy (31 Gy in 5 treatments over two weeks) works as well and has acceptable side effects as a moderate course (60 Gy in 24 treatments over 5–6 weeks) for men with a rising PSA after prostatectomy.

Quick facts

PhasePhase 3
Study typeInterventional
Ages20 Years and up
SexMen only
Enrollment270 (estimated)
SponsorSamsung Medical Center
Academic / other
Drugs / interventionsradiation
Locations1 site (Seoul, Gangnam-gu)
StatusRecruiting
StartedMarch 6, 2026
Main results expectedDecember 31, 2034
Study endsDecember 31, 2034
Registry record updatedMarch 30, 2026
Trial IDNCT07500701 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged 20 or older who have had radical prostatectomy, have persistent or rising PSA between 0.1 and 1.0 ng/mL with at least three consecutive increases, ECOG 0–1, and no metastasis on PSMA PET/CT are ideal candidates.

Probably not a fit

Patients with radiologic or clinical evidence of gross local recurrence, lymph node or distant metastasis, prior pelvic radiotherapy, or PSA values outside the specified range are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, phase III non-inferiority trial comparing ultrahypofractionated salvage radiotherapy (31 Gy in 5 fractions given every other day) with moderate hypofractionated salvage radiotherapy (60 Gy in 24 daily fractions) for patients with biochemical recurrence after radical prostatectomy. Eligible patients have a rising PSA (0.1–1.0 ng/mL with at least three consecutive increases), good performance status (ECOG 0–1), and no evidence of local, nodal, or distant disease on PSMA PET/CT. Participants are randomized to one of the two radiation schedules and followed for oncologic outcomes, toxicity, and patient-reported effects. The trial is designed to show that the shorter regimen is not worse than the moderate schedule in cancer control while maintaining acceptable toxicity and convenience.

Why it matters

Potential benefit: If successful, the ultrahypofractionated approach could offer similar cancer control with a much shorter treatment time, lower cost, and greater convenience for patients.

How similar studies have gone: Ultrahypofractionation has shown non-inferiority to standard schedules in primary prostate radiotherapy, but robust phase III data in the postoperative salvage setting are limited, making this approach relatively novel for salvage treatment.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.)

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.