Actively Recruiting

Phase 2
Age: 18Years +
MALE
Healthy Volunteers
NCT05946824

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.

Led by University of Rochester · Updated on 2024-10-08

80

Participants Needed

1

Research Sites

258 weeks

Total Duration

On this page

Sponsors

U

University of Rochester

Lead Sponsor

V

Varian Medical Systems

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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.

Who Can Participate

Age: 18Years +
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Metastatic disease
  • Prior radiation therapy to the pelvis region
  • Inflammatory bowel disease
  • Hospitalization for a gastrointestinal diagnosis in the preceding 3 months
  • Hospitalization for a urinary tract issue / diagnosis in the preceding 3 months
  • PSA >10 ng/dl at study entry

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wilmot Cancer Institute - Dept of Radiation Oncology

Rochester, New York, United States, 14624

Actively Recruiting

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Research Team

M

Michael Cummings, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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