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.
Daily-Adaptive Stereotactic Body Radiation Therapy for Biochemically Recurrent, Radiologic Apparent Prostate Cancer After Radical Prostatectomy
About This Trial
- This study is for people whose prostate cancer has returned in the pelvis after having surgery to remove their prostate.
- Researchers are testing a new radiation technique that uses artificial intelligence to deliver precise, higher doses of radiation in a much shorter timeframe than the typical seven-week schedule.
- The goal is to see if this faster treatment can safely control the returning cancer while reducing side effects.
- Before joining, patients should know that this study is only for cancer that has not spread to distant parts of the body, and it is not open to those who have previously had pelvic radiation or recent serious bowel or bladder issues.
More Information
- 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 Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is for people whose prostate cancer has returned in the pelvis after having surgery to remove their prostate.
Study Details
- Start Date: December 14, 2023
- Lead Sponsor: University of Rochester
Full 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,
Treatments
- Radiation: Daily-adaptive Stereotactic Body Radiation Therapy

