Study on Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer

Sponsor: University of Florida

Sponsor score: 60

ClinicalTrials ID:NCT03624660

Provider View

This clinical trial is exploring whether increasing the dose of proton radiation therapy can effectively treat high-risk prostate cancer. The study involves advanced imaging techniques to target the tumor more precisely and includes hormone therapy for some patients.

Patient Parameters

Program Overview

The aim of this study is to find out if increasing the dose of proton radiation therapy can be an effective treatment for high-risk prostate cancer. Proton therapy is a type of radiation that targets the tumor more precisely, potentially reducing damage to surrounding healthy tissues. This study uses advanced MRI imaging to identify the tumor within the prostate and deliver a higher dose of radiation directly to it. Patients will receive radiation therapy over 8-9 weeks, and some may also receive hormone therapy starting 8-10 weeks before radiation and continuing for 18 months.

Description

Prostate cancer is the most common cancer among men in the U.S. This study is testing if a higher dose of proton radiation therapy can better treat high-risk prostate cancer. Proton therapy aims to reduce radiation exposure to healthy tissues while focusing more on the tumor. By using MRI imaging, doctors can target the tumor more accurately, potentially improving treatment outcomes and reducing side effects.

The study involves giving radiation therapy over 8-9 weeks. Some patients may also receive hormone therapy, which starts 8-10 weeks before radiation and continues for 18 months. This approach aims to improve cancer control and minimize side effects.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Must be at least 18 years old.
  • Have prostate cancer diagnosed as stage T1 to T3b through biopsy within the last year.
  • Must have an MRI scan of the prostate within 6 months before joining the study.
  • The tumor must be visible on MRI within the prostate or seminal vesicles.
  • Must have at least one high-risk factor, such as advanced stage, high Gleason score, or high PSA levels.
  • Hemoglobin levels must be at least 10 g/ml.
  • Must have a performance status score of 0 or 1, indicating good overall health.
  • Must agree to use contraception if capable of having children.
  • Must be able to start treatment within 16 weeks of joining the study.

Exclusion Criteria

  • Have stage T4 prostate cancer.
  • Unable to undergo an MRI scan.
  • Significant change in prostate size between scans.
  • Tumor occupies more than 75% of the prostate.
  • Evidence of cancer spread beyond the prostate.
  • Previous treatments for prostate cancer, such as surgery or radiation.
  • Recent heart attack or severe heart failure.
  • Active inflammatory bowel disease affecting the rectum.
  • Previous hip replacement surgery.
  • Previous pelvic surgery, including bladder surgery.
  • Currently taking blood thinners or anticoagulants.

Locations

FACILITYZIPCITYSTATE
University of Florida Health Proton Therapy Institute32206JacksonvilleFlorida

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