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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.

RECRUITINGPhase 2Sponsored by University of Rochester
Actively Recruiting
PhasePhase 2
SponsorUniversity of Rochester
Started2023-12-14
Est. completion2025-11-24
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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,

Conditions2

CancerRecurrent Prostate Cancer After Surgery

Locations1 site

Wilmot Cancer Institute - Dept of Radiation Oncology
Rochester, New York, 14624
Michael Cummings, MD585-275-5622michael_cummings@urmc.rochester.edu

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