NCT07500701 Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Prostatectomy in Prostate Cancer
| NCT ID | NCT07500701 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Samsung Medical Center |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2026-03-06 |
| Primary Completion | 2034-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 270 participants in total. It began in 2026-03-06 with a primary completion date of 2034-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07500701 clinical trial?
This trial is open to male participants only, aged 20 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07500701 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 270 participants.
Is NCT07500701 currently recruiting?
Yes, NCT07500701 is actively recruiting participants. Contact the research team at wonro.park@samsung.com for enrollment information.
Where is the NCT07500701 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07500701 clinical trial?
NCT07500701 is sponsored by Samsung Medical Center. The trial plans to enroll 270 participants.
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