Short-course versus moderate-course salvage radiation for rising PSA after prostate removal
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 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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 20 Years and up |
| Sex | Male |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Seoul, Gangnam-gu) |
| Trial ID | NCT07500701 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul, Gangnam-gu
- Samsung Medical Center — Seoul, Gangnam-gu, South Korea (Recruiting)
Study contacts
- Study coordinator: Won Park
- Email: wonro.park@samsung.com
- Phone: +82-10-9933-2616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.