NCT05946824 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.
| NCT ID | NCT05946824 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Rochester |
| Condition | Recurrent Prostate Cancer After Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-12-14 |
| Primary Completion | 2025-11-24 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
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,
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