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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.

NCT05946824 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-10-08

No results posted yet for this study

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.

Conditions

  • Recurrent Prostate Cancer After Surgery

Interventions

RADIATION

Daily-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

RADIATION

Daily-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

Sponsors & Collaborators

  • Varian Medical Systems

    collaborator INDUSTRY

  • University of Rochester

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-14
Primary Completion
2025-11-24
Completion
2028-11-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05946824 on ClinicalTrials.gov