Study on PYLARIFY® PET/CT or PET/MRI for Men with Favorable Intermediate Risk Prostate Cancer

Sponsor: Lantheus Medical Imaging

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06074510

Provider View

This clinical trial is exploring whether PYLARIFY PET imaging can safely and accurately detect prostate cancer that may have spread beyond the prostate gland in men with favorable intermediate risk prostate cancer.

Patient Parameters

Program Overview

The aim of this study is to determine if PYLARIFY PET imaging can effectively identify prostate cancer that has spread beyond the prostate gland in men with favorable intermediate risk prostate cancer. Participants will receive a single dose of PYLARIFY, followed by a whole-body PET/CT or PET/MRI scan 1 to 2 hours later. If the scan shows signs of cancer outside the prostate, additional tests or treatments may be recommended within 2 to 90 days. Participants will be monitored for up to 12 months to track their treatment and PSA blood test results.

Eligibility Criteria

Inclusion Criteria

  • Able to understand and sign a consent form.
  • Able to follow all study requirements.
  • Aged 18 years or older.
  • In good general health with a performance status score of 0 to 2.
  • Expected to live at least 13 months.
  • Diagnosed with favorable intermediate risk prostate cancer, meeting specific criteria:
    • One intermediate risk factor (cT2b-cT2c, ISUP Grade Group 2, or PSA 10-20 ng/mL).
    • ISUP Grade Group 1 or 2.
    • Less than 50% of biopsy samples positive for cancer.
  • Prostate biopsy must be done 2 weeks to 3 months before the PYLARIFY scan.

Exclusion Criteria

  • Received any high-energy gamma-emitting radioisotope within a certain time before the study.
  • Previous prostate cancer treatments like radiation, hormone therapy, surgery, or experimental treatments.
  • Allergic to PYLARIFY or similar substances.
  • Any medical condition or situation that might affect safety or study completion.
  • Evidence of advanced prostate cancer on standard imaging tests.

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