RecruitingPhase 2NCT05946824

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


Sponsor

University of Rochester

Enrollment

80 participants

Start Date

Dec 14, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new radiation therapy technique (MR-guided adaptive stereotactic body radiotherapy) for men whose prostate cancer has come back after having their prostate surgically removed. The treatment uses detailed MRI imaging to precisely target the recurrence while minimizing damage to surrounding healthy tissue. **You may be eligible if...** - You have had surgery to remove your prostate for cancer - Imaging has detected your cancer returning in the surgical area or nearby lymph nodes - Two PSA blood tests (taken at least 30 days apart) show detectable levels above 0.02 ng/dL **You may NOT be eligible if...** - Your cancer has spread to distant parts of your body - You have had prior radiation to the pelvis - You have inflammatory bowel disease - You were recently hospitalized for bowel or urinary problems - Your PSA is above 10 ng/dL at the time of enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONDaily-adaptive Stereotactic Body Radiation Therapy

Daily-adaptive radiation therapy to two dose levels - one to the area of radiologic recurrent nodal disease, and a lower, prophylactic dose to the standard post-prostatectomy and larger pelvic node fields

RADIATIONDaily-adaptive Stereotactic Body Radiation Therapy

Daily-adaptive radiation therapy to two areas - a high dose to the area of radiologic recurrence, and a lower, prophylactic dose to the standard post-prostatectomy fields


Locations(1)

Wilmot Cancer Institute - Dept of Radiation Oncology

Rochester, New York, United States

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NCT05946824