TERPS Trial for Newly Diagnosed Prostate Cancer with Limited Spread

Sponsor: University of Maryland, Baltimore

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05223803

Provider View

This study is exploring whether adding a special type of radiation therapy to the usual treatment can improve outcomes for prostate cancer patients whose cancer has spread to a few areas at the time of diagnosis.

Patient Parameters

Program Overview

The purpose of this study is to find out if adding a targeted radiation treatment called stereotactic ablative radiation therapy (SABR) to the standard treatment can help improve outcomes for prostate cancer patients whose cancer has spread to a few areas. The study will compare the usual treatment, which includes medication and radiation to the prostate, with the same treatment plus SABR to the areas where the cancer has spread. Researchers will also look at how this affects the chances of the cancer coming back, the presence of cancer cells in the blood, gut bacteria, and the quality of life for patients.

Description

This study is designed to compare the effects of the standard treatment for prostate cancer, which includes medication and radiation to the prostate, with an enhanced treatment that adds a special type of radiation called stereotactic ablative radiation therapy (SABR) to the areas where the cancer has spread. The goal is to see if this additional treatment can improve outcomes for patients whose cancer has spread to a few areas at the time of diagnosis. Researchers will also assess how this affects the recurrence of cancer, the presence of cancer cells in the blood, gut bacteria, and the quality of life for patients.

Eligibility Criteria

Inclusion Criteria

  • Have 1 to 3 areas of cancer spread to bones or soft tissue, with at least one in the bone, detected within the last 6 months on scans. Up to 5 areas can be seen on advanced scans like PET-CT.
  • Have a confirmed diagnosis of cancer.
  • May have had previous medication or hormone therapy within 9 months before joining the study.
  • PSA level between 0.5 and 100.
  • Be 18 years or older.
  • Have a life expectancy of at least 12 months.
  • Be in relatively good health with an ECOG performance status of 2 or less.
  • Be able to understand and willing to sign a consent form.

Exclusion Criteria

  • Have prostate cancer that no longer responds to hormone therapy.
  • Have had radiation to the same area that would prevent more radiation.
  • Have or are at risk of spinal cord compression.
  • Have suspected cancer spread to the lungs or liver larger than 10 mm.
  • Are taking other experimental treatments.
  • Cannot receive any form of medication treatment as determined by a doctor.
  • Cannot lie flat or tolerate scans or SABR.
  • Have no evidence of cancer spread to the brain.
  • Do not agree to sign the consent form.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.