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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a shorter course of radiation that uses artificial intelligence (AI) to help adjust treatment each day. It is for people whose prostate cancer has returned near the surgery site or in nearby lymph nodes after surgery. The goal is to control the cancer and limit side effects.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Had surgery for prostate adenocarcinoma, a type of prostate cancer.
- Scans show cancer has returned where the prostate was removed or in certain nearby pelvic lymph nodes.
- Had at least two blood tests for PSA, a marker of prostate cancer, at least 30 days apart. Both levels must be above 0.02 ng/dl.
Who can't join
- Cancer has spread to distant parts of the body.
- Had radiation treatment to the pelvis, the lower belly area.
- Have inflammatory bowel disease, which causes swelling in the digestive tract.
- Were hospitalized for a digestive tract problem in the past 3 months.
- Were hospitalized for a urinary tract problem in the past 3 months.
- Have a PSA level above 10 ng/dl when entering the study.
Simplified for readability. The official criteria below are what the study team uses.
Official 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,
Study sites (1)
NY
- Wilmot Cancer Institute - Dept of Radiation Oncology · Rochester, NY 14624Michael Cummings, MD · Study contact · 585-275-5622 · michael_cummings@urmc.rochester.eduMichael Cummings, MD · Study contactMore trials in Rochester