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This Study is Evaluating a New Radiation Treatment Technique for Patients Who Have Had Prostate Cancer, Undergone Surgery for Cancer, and Then Have Evidence That Their Prostate Cancer Has Returned.
Daily-Adaptive Stereotactic Body Radiation Therapy for Biochemically Recurrent, Radiologic Apparent Prostate Cancer After Radical Prostatectomy
Who can join
Ages 18 and older · Men · Healthy volunteers welcome
Full eligibility 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,
About the study
There is significant, proven use of radiation for recurrent prostate cancer after surgical resection. This treatment typically is delivered over seven and a half weeks of daily treatments, presenting a burden to patients and the health care system. Stereotactic body radiation (SBRT) is a radiation technique in which large doses are delivered over a short period of time. To date there is extremely limited evidence in SBRT for recurrent prostate cancer after surgery, with a significantly growing body of evidence for primary SBRT treatment of prostate cancer in men who opt for non-surgical upfront treatment. Additionally, advances in imaging have allowed better detection of the site of recurrence, and novel artificial intelligence aided daily-adaptive radiation therapy have allowed more precise delivery of radiation doses. This study seeks to evaluate the role of Daily-Adaptive with AI-assisted SBRT in the post operative setting utilizing Ethos Plan Adaptive technology in attempt to maintain control and minimize side effects.
What is being tested
- Daily-adaptive Stereotactic Body Radiation Therapy (radiation)
- Daily-adaptive Stereotactic Body Radiation Therapy (radiation)
Sponsor: University of Rochester · Participants: 80 · Started: Dec 14, 2023
Contact the study team
- Michael Cummings, MD · Phone: 585-275-5622
Official record on ClinicalTrials.gov — NCT05946824
Locations in the U.S.
| New York | Wilmot Cancer Institute - Dept of Radiation Oncology, Rochester |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.