Study on a New Radiation Treatment for Patients with Recurrent Prostate Cancer After Surgery

Sponsor: University of Rochester

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05946824

Provider View

This clinical trial is testing a new radiation technique for patients whose prostate cancer has returned after surgery. The study aims to see if this new method, which uses advanced imaging and artificial intelligence, can effectively control cancer while reducing side effects.

Patient Parameters

Program Overview

This study is exploring a new radiation treatment called Stereotactic Body Radiation Therapy (SBRT) for patients whose prostate cancer has come back after surgery. Traditional radiation treatment for recurrent prostate cancer usually takes over seven weeks, which can be burdensome. SBRT delivers larger doses of radiation over a shorter period, potentially making treatment more convenient. Recent advances in imaging and artificial intelligence have improved the precision of radiation delivery, which this study will evaluate using a technology called Ethos Plan Adaptive. The goal is to maintain cancer control while minimizing side effects.

Description

The study is a Phase II trial conducted at a single center and includes two groups of patients. Initially, a small group of 7 patients will be treated to assess the safety of the new radiation method. This phase will help determine if the treatment causes any significant side effects, particularly in the gastrointestinal or urinary systems, which could affect daily activities like bathing or cooking. If the treatment is found to be safe, more patients will be enrolled. The study will stop if two or more patients experience severe side effects, as this would indicate an unacceptable level of risk. The trial aims to ensure that the new radiation technique is safe and effective for patients with recurrent prostate cancer after surgery.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer and have had surgery to remove it.
  • Cancer has returned and is detected in the prostate area or nearby lymph nodes through imaging tests.
  • Have had at least two blood tests showing rising PSA levels (greater than 0.02 ng/dl) at least 30 days apart.

Exclusion Criteria

  • Cancer has spread to other parts of the body (metastatic disease).
  • Have had previous radiation therapy to the pelvic area.
  • Have inflammatory bowel disease.
  • Have been hospitalized for gastrointestinal issues in the last 3 months.
  • Have been hospitalized for urinary tract issues in the last 3 months.
  • PSA level is greater than 10 ng/dl at the start of the study.

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