Study on Using PSMA PET/MR Guided Radiation Therapy for High-Intermediate and High Risk Prostate Cancer

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04402151

Provider View

This clinical trial is testing a new radiation therapy guided by advanced imaging techniques to improve treatment outcomes for patients with high-intermediate and high-risk prostate cancer.

Patient Parameters

Program Overview

This study is exploring a new approach to treating prostate cancer using advanced imaging and radiation techniques. The trial involves 50 patients and aims to see if using PSMA PET/MR imaging to guide a precise form of radiation therapy can improve outcomes for those with high-risk prostate cancer. This method targets the areas most likely to have cancer return, using real-time imaging to adjust the treatment as needed.

Description

Prostate cancer can be treated with a precise form of radiation called stereotactic body radiation therapy (SBRT), which is delivered in just five sessions. However, for aggressive prostate cancer, the chances of the cancer not coming back after 10 years are only about 65%, and if it does return, it often spreads to other parts of the body, leading to a poor outlook. This study aims to improve these outcomes by using the latest imaging technology, PSMA PET/MR, to guide the radiation treatment. This imaging provides detailed pictures of the prostate and helps identify areas at high risk of cancer returning. The treatment is delivered using a special machine that allows doctors to see the tumor during treatment and make real-time adjustments. This approach aims to provide more personalized and precise treatment, potentially improving the chances of controlling the cancer.

Eligibility Criteria

Inclusion Criteria

  • Men aged 21 years or older.
  • Able to provide informed consent and willing to follow study requirements.
  • Diagnosed with high-risk prostate cancer, which includes:
    • Gleason score of 8-10 or a specific component of 5, and/or
    • PSA level of 20 ng/ml or higher, and/or
    • Tumor stage T2c or higher.
  • Alternatively, diagnosed with unfavorable intermediate risk prostate cancer, which includes:
    • Gleason score of 4+3=7, more than 50% of biopsy samples involved, or two or more intermediate risk factors such as Gleason 7, PSA 10-20, or T2b stage.
  • Must agree to use birth control and condoms for seven days after each PSMA injection if sexually active.
  • No signs of cancer spread, including to pelvic lymph nodes.

Exclusion Criteria

  • Any factors that would affect the analysis of PET or MR imaging.
  • Unable to receive PSMA IV injections.
  • Unable to undergo prostate SBRT due to:
    • History of certain prostate surgeries.
    • Prostate size over 150 cc.
    • High urinary symptom score (AUA score over 20).
    • Previous radiation to the prostate.
  • Any other reasons deemed unsuitable by the study investigators.
  • Patients currently taking or planning to take the medication abiraterone.

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