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.
Recruiting · NCT05946824 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Rochester
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed across 1 US state.
- Wilmot Cancer Institute - Dept of Radiation Oncology - Rochester, New York, United States