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RecruitingAccepts healthy volunteersPhase 2

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.

University of Rochester · with Varian Medical Systems · NCT05946824

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Men only
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
80
US sites recruiting
1
Study start
December 14, 2023
Record last updated
October 8, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Daily-adaptive Stereotactic Body Radiation Therapy; Daily-adaptive Stereotactic Body Radiation Therapy

Conditions: Recurrent Prostate Cancer After Surgery

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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,

Recruiting US locations

  • Wilmot Cancer Institute - Dept of Radiation Oncology

    Rochester, NY 14624

    Site contact: Michael Cummings, MD · 585-275-5622 · michael_cummings@urmc.rochester.edu

Study contacts (from the official record)

  • Michael Cummings, MD · 585-275-5622 · michael_cummings@urmc.rochester.edu
All healthy volunteers studies in New York →
This Study is Evaluating a New Radiation Treatment Technique for… (NCT05946824) | Bored Studies