Daily-Adaptive Stereotactic Body Radiation Therapy for Biochemically Recurrent, Radiologic Apparent Prostate Cancer After Radical Prostatectomy

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
New York
Wilmot Cancer Institute - Dept of Radiation Oncology
RECRUITING
Rochester
Contact Information
Primary
Michael Cummings, MD
michael_cummings@urmc.rochester.edu
585-275-5622
Time Frame
Start Date: 2023-12-14
Estimated Completion Date: 2028-11-24
Participants
Target number of participants: 80
Treatments
Experimental: 1 - Prostate bed only recurrence
Patients with confirmed radiologic recurrence of their prostate cancer in the defined region of the previous prostate surgery - commonly referred to as the prostate surgical bed.
Experimental: 2- Pelvic nodal with or without a prostate bed recurrence
Patients who have a radiologic recurrence of prostate cancer in the pelvic node region
Related Therapeutic Areas
Sponsors
Collaborators: Varian Medical Systems
Leads: University of Rochester

This content was sourced from clinicaltrials.gov