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 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2023-12-14 with a primary completion date of 2025-11-24.
⚠ 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
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,
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05946824 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Recurrent Prostate Cancer After Surgery. 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 NCT05946824 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05946824 currently recruiting?
Yes, NCT05946824 is actively recruiting participants. Contact the research team at michael_cummings@urmc.rochester.edu for enrollment information.
Where is the NCT05946824 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05946824 clinical trial?
NCT05946824 is sponsored by University of Rochester. The trial plans to enroll 80 participants.
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