Study on MRI-based Targeted Radiation Therapy for Low to Intermediate Risk Prostate Cancer

Sponsor: Georgetown University

Sponsor score: 40

ClinicalTrials ID:NCT07644598

Provider View

This clinical trial is testing a new radiation therapy technique that uses MRI to target specific areas of the prostate in patients with low to intermediate risk prostate cancer. The study aims to determine if this approach is safe and effective while minimizing side effects.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety of a new radiation therapy method called stereotactic body radiation therapy (SBRT) microboost for patients with low to intermediate risk prostate cancer. The main question is whether this targeted approach, combined with a lower dose to the whole prostate, is both safe and effective in managing the cancer while keeping side effects acceptable. All participants will receive targeted SBRT to specific areas identified by MRI, with different doses depending on the location of the highest grade cancer. Treatment will occur every other day over two weeks, followed by monitoring for up to five years. Participants will also complete questionnaires and provide blood and urine samples for research.

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Diagnosed with prostate cancer that has not been treated with radiation or surgery.
  • Classified as low to intermediate risk prostate cancer based on specific medical guidelines.
  • For certain intermediate risk patients, a PSMA PET scan must show localized disease.
  • Must have had an MRI fusion biopsy to identify prostate lesions and confirm no spread of cancer.
  • Prostate size less than 100 cc on MRI.
  • Up to 4 visible lesions allowed, with specific characteristics.
  • Good urinary function as measured by a questionnaire.
  • Must have fiducial markers placed, with optional rectal spacer if needed.
  • Life expectancy greater than 5 years based on specific tools and health assessment.
  • Agree to use contraception or remain abstinent during and after treatment.
  • Able to give informed consent.

Exclusion Criteria

  • Cancer grade group 4 or higher.
  • PSA level greater than 20 ng/mL.
  • Advanced cancer stage or significant spread outside the prostate.
  • Previous hormone therapy for prostate cancer.
  • More than 4 cancerous areas on MRI.
  • Evidence of cancer spread to other parts of the body.
  • Inability to undergo MRI due to medical devices, claustrophobia, or other reasons.
  • Poor urinary function as measured by a questionnaire.
  • Recent prostate procedures within the last 6 months.
  • History of severe urethral stricture.
  • Previous pelvic radiation.
  • Inability to meet specific radiation dose requirements.
  • History of other cancers within the last 5 years, except skin cancer.
  • Active inflammatory bowel disease.
  • Inability to comply with follow-up visits and treatment plans.

Locations

FACILITYZIPCITYSTATE
Lombardi Comprehensive Cancer Center, Georgetown University20007Washington D.C.District of Columbia

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