RecruitingPhase 3

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

South Korea270 participantsStarted 2026-03-06

Plain-language 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.

Who can participate

Age range

20 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

5-year biochemical progression-free survival (bPFS)

Timeframe: 5 years after treatment completion

Trial details

NCT IDNCT07500701

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2034-12-31

Contact for this trial

Won Park

+82-10-9933-2616 wonro.park@samsung.com

View on ClinicalTrials.gov More Prostate Cancer trials