Actively Recruiting
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.
Led by University of Rochester · Updated on 2024-10-08
80
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
V
Varian Medical Systems
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Metastatic disease
- Prior radiation therapy to the pelvis region
- Inflammatory bowel disease
- Hospitalization for a gastrointestinal diagnosis in the preceding 3 months
- Hospitalization for a urinary tract issue / diagnosis in the preceding 3 months
- PSA >10 ng/dl at study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wilmot Cancer Institute - Dept of Radiation Oncology
Rochester, New York, United States, 14624
Actively Recruiting
Research Team
M
Michael Cummings, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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