Evaluating a new radiation treatment for recurrent prostate cancer after surgery
Official title: Daily-Adaptive Stereotactic Body Radiation Therapy for Biochemically Recurrent, Radiologic Apparent Prostate Cancer After Radical Prostatectomy
Run by University of Rochester · NCT05946824 · Data updated 2026-11-12
This study is testing a new type of radiation treatment for men with recurring prostate cancer after surgery to see if it works better and is easier than the usual methods.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 80 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, New York) |
| Status | Recruiting |
| Started | December 14, 2023 |
| Main results expected | November 24, 2025 |
| Study ends | November 24, 2028 |
| Registry record updated | October 8, 2024 |
| Trial ID | NCT05946824 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men with adenocarcinoma of the prostate who have had surgical resection and show evidence of recurrence in the prostate bed or regional nodes.
✕Probably not a fit
Patients with metastatic disease or those who have received prior radiation therapy to the pelvic region will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is investigating a novel approach to treat recurrent prostate cancer in patients who have previously undergone surgery. It focuses on using Daily-Adaptive Stereotactic Body Radiation Therapy (SBRT) with AI-assisted technology to deliver precise radiation doses over a shorter treatment period compared to traditional methods. The study will assess the safety and efficacy of this treatment in a two-cohort Phase II design, starting with a safety lead-in to evaluate potential toxicity. The goal is to improve patient outcomes while reducing the burden of lengthy treatment schedules.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and less time-consuming option for patients with recurrent prostate cancer.
How similar studies have gone: While there is limited evidence specifically for SBRT in this context, advances in imaging and AI-assisted therapies suggest potential for success based on related studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adenocarcinoma of the prostate with previous surgical resection * Radiologically detected prostate bed OR regional nodal recurrence defined as iliac, obturator, perirectal or pre-sacral node generally encompassing below the aortic bifurcation * Prostate bed recurrence as occurring within the region of the prostate or RTOG consensus definition of the surgical field * At least two serum detectable PSA levels defined as \>0.02 ng/dl at least 30 days apart. Exclusion Criteria: * Metastatic disease * Prior radiation therapy to the pelvis region * Inflammatory bowel disease * Hospitalization for a gastrointestinal diagnosis in the preceeding 3 months * Hospitalization for a urinary tract issue / diagnosis in the preceeding 3 months * PSA \>10 ng/dl at study entry,
Where it's running
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Wilmot Cancer Institute - Dept of Radiation Oncology
Rochester, New York, United States Recruiting
Study contacts
- Study coordinator: Michael Cummings, MD
- Email: michael_cummings@urmc.rochester.edu
- Phone: 585-275-5622
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating the effectiveness of a new imaging method for prostate cancer recurrence
This study is testing a new imaging method to see if it can help doctors better detect prostate cancer recurrence in patients who have already been treated.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.