Evaluation of Prostate Specific Membrane Antigen Positron Emission Tomography-Computed Tomography in Active Surveillance for Prostate CancEr

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Jul 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a type of imaging called PSMA-PET CT to see how well it can help identify if men with low-risk or favorable intermediate-risk prostate cancer do not have significant disease while they are on a treatment plan called active surveillance. Active surveillance means closely monitoring the cancer without immediate treatment, allowing men to avoid potential side effects from more aggressive treatments if the cancer is not progressing.

To join this study, participants must be men aged 18 or older who have been diagnosed with low-risk or favorable intermediate-risk prostate cancer. They should have a specific level of prostate-specific antigen (PSA) in their blood and must be willing to undergo yearly imaging and biopsies. Throughout the trial, participants can expect to have regular check-ups, including imaging tests and surveys about their quality of life. It’s important to note that men who have had prior treatments for prostate cancer or who are not interested in active surveillance are not eligible to participate.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Males aged ≥ 18.
• • Histologically confirmed low or favorable intermediate risk prostate cancer per NCCN guidelines. (Note: Grade Group 2 must have 20% or less involvement in every core and no presence of cribiform or intraductal carcinoma).
• • PSA \< 20 ng/ml.
• • Ability to undergo yearly PSMA-PET CT.
• • Ability to undergo yearly prostate mpMRI.
• • Ability to undergo transrectal or transperineal template and fusion prostate biopsy.
• • Ability to complete HRQOL surveys (EPIC, IPSS, IIEF-5).
• • Willingness to undergo yearly prostate biopsies.
• Exclusion Criteria:
• • History of prior treatment for prostate cancer.
• • History of systemic therapy for prostate cancer.
• • Inability to undergo transrectal ultrasound.
• • Life expectancy less than 10 years.
• • Not interested in pursuing active surveillance.
• • Initial diagnosis of prostate cancer greater than 15 months.