Evaluating a new radiation treatment for recurrent prostate cancer after surgery
Daily-Adaptive Stereotactic Body Radiation Therapy for Biochemically Recurrent, Radiologic Apparent Prostate Cancer After Radical Prostatectomy
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 |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT05946824 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rochester, New York
- 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
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.