Focal Therapy with Stereotactic Body Radiation Therapy (SBRT) for Patients with a Single Prostate Tumor

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05616650

Provider View

This study is exploring a new type of radiation treatment called SBRT for men with early-stage prostate cancer that hasn't spread. The goal is to see if this treatment can effectively target the cancer with fewer side effects than traditional methods.

Patient Parameters

Program Overview

The study is testing a new radiation treatment called Stereotactic Body Radiation Therapy (SBRT) for men with early-stage prostate cancer that hasn't spread beyond the prostate gland. Traditional treatments often involve removing or radiating the entire prostate, which can lead to side effects. This study aims to see if SBRT can target the cancer more precisely, potentially reducing side effects. Participants will undergo various tests and procedures, including MRI and PET/CT scans, and will receive two sessions of SBRT about a week apart. Follow-up will continue for two years to monitor the treatment's effectiveness.

Description

Prostate cancer is the most common cancer among men in the U.S. Traditional treatments like surgery or full prostate radiation can have significant side effects. This study is investigating a new approach using Stereotactic Body Radiation Therapy (SBRT), which targets only the cancerous part of the prostate. This method could offer effective cancer control with fewer side effects.

Participants will undergo initial tests, including blood tests, MRI, and PET/CT scans, to confirm the cancer's location. Small gold markers will be placed around the tumor to help guide the radiation. The SBRT treatment will be given in two sessions, each lasting 1-2 hours, with no need for sedation. After treatment, participants will have regular follow-ups, including scans and blood tests, for two years to assess the treatment's impact.

The study aims to recruit 30 participants, with a maximum of 42, to evaluate the effectiveness of SBRT in treating localized prostate cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of low or intermediate risk prostate cancer based on a biopsy.
  • Cancer must be localized to a single area within the prostate, as shown by MRI and PET/CT scans.
  • Must be 18 years or older.
  • Must be in good general health, with a performance status score of 0 to 2.
  • Must agree to use effective birth control during the study and for 120 days after the last radiation treatment.
  • Must be able to understand and sign a consent form agreeing to participate in the study.

Exclusion Criteria

  • Have high-risk prostate cancer features, such as a high Gleason score or high PSA levels.
  • Have cancer that has spread beyond the visible tumor area.
  • Plan to receive hormone therapy or chemotherapy during the study.
  • Are participating in another clinical trial.
  • Have cancer that has spread to other parts of the body.
  • Have a high score on a urinary symptom questionnaire.
  • Have previously received treatment for prostate cancer.
  • Have an active urinary tract infection.
  • Have untreated or uncontrolled HIV, hepatitis B, or hepatitis C infections.
  • Have certain medical conditions that make the planned treatment unsafe.
  • Are unable or unwilling to undergo necessary scans or procedures required for the study.

Get This Program In Your Inbox

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