Diagnostic Performance of PSMA PET/CT for Pre-operative Lymph Node Assessment in Intermediate and High-risk Non-metastasic Prostate Cancer (PREOP-PSMA ).

Launched by UNIVERSITY HOSPITAL, BREST · Feb 5, 2021

Keywords

ClinConnect Summary

The PREOP-PSMA clinical trial is studying a new imaging test called PSMA PET/CT to see how well it can assess lymph nodes in men with intermediate and high-risk prostate cancer before surgery. This trial is important because prostate cancer is very common in men over 50, and accurately checking whether the cancer has spread is crucial for planning the best treatment. The goal is to see if this new imaging method is more effective than traditional imaging tests, which can sometimes miss cancer in the lymph nodes.

To be eligible for this trial, participants must have confirmed prostate cancer that falls into the intermediate or high-risk categories, as determined by specific medical criteria. They should be planning to have surgery to remove the prostate. The trial is currently recruiting male participants aged 65 to 74. Those who join can expect to undergo the PSMA PET/CT scan, which may provide more detailed information about their cancer and help guide their treatment options.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed prostate cancer;
• • Intermediate-risk prostate cancer (PSA level of 10- 20 ng/mL and/or Clinical tumor stage ≥ T2b and/or ISUP 2 or 3, AND with risk of lymph node extension \> 5% according to the Briganti nomogram) or high-risk prostate cancer (PSA ≥ 20 ng/mL and/or TR ≥ T2c and/or ISUP 4 or 5) according to d'Amico classification;
• • Curative treatment by radical prostatectomy chosen by the multidisciplinary consultation meeting.
• Exclusion Criteria:
• • Refusal or inability to participate in the study ;
• • Low-risk prostate cancer according to D'Amico's classification, or an intermediate-risk but with a risk of lymph node extension \<5% according to Briganti's nomogram;
• • Curative treatment other than surgical treatment chosen;
• • Life expectancy \< 12 months;
• • Karnofsky score \< 70 or ECOG score \> 2.