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.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-14
Study Completion:2028-11-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05946824

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adenocarcinoma of the prostate with previous surgical resection
  2. * Radiologically detected prostate bed OR regional nodal recurrence defined as iliac, obturator, perirectal or pre-sacral node generally encompassing below the aortic bifurcation
  3. * Prostate bed recurrence as occurring within the region of the prostate or RTOG consensus definition of the surgical field
  4. * At least two serum detectable PSA levels defined as \>0.02 ng/dl at least 30 days apart.
  1. * Metastatic disease
  2. * Prior radiation therapy to the pelvis region
  3. * Inflammatory bowel disease
  4. * Hospitalization for a gastrointestinal diagnosis in the preceeding 3 months
  5. * Hospitalization for a urinary tract issue / diagnosis in the preceeding 3 months
  6. * PSA \>10 ng/dl at study entry,

Contacts and Locations

Study Contact

Michael Cummings, MD
CONTACT
585-275-5622
michael_cummings@urmc.rochester.edu

Study Locations (Sites)

Wilmot Cancer Institute - Dept of Radiation Oncology
Rochester, New York, 14624
United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-14
Study Completion Date2028-11-24

Study Record Updates

Study Start Date2023-12-14
Study Completion Date2028-11-24

Terms related to this study

Keywords Provided by Researchers

  • Stereotactic body radiation therapy
  • daily-adaptive radiation therapy
  • prostate cancer
  • recurrent prostate cancer

Additional Relevant MeSH Terms

  • Recurrent Prostate Cancer After Surgery