Dutch National Randomized Study: PSMA-PET/CT As a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients

Launched by CANISIUS-WILHELMINA HOSPITAL · Aug 9, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help doctors decide if a specific surgical procedure called extended lymph node dissection (ePLND) is necessary for men with prostate cancer. The study is looking at a special imaging test called PSMA PET/CT, which helps identify cancer in the lymph nodes. The goal is to see if using this imaging tool can reduce the number of ePLND surgeries, leading to fewer complications for patients, lower healthcare costs, and similar outcomes in managing the cancer compared to current standard practices.

To take part in the trial, participants need to be men aged 65 to 74 with a confirmed diagnosis of prostate cancer and a recommendation for ePLND combined with a robot-assisted surgery. They must be mentally capable of understanding the study's purpose and willing to give consent. Participants will undergo the PSMA PET/CT scan and may have the ePLND surgery if needed. This trial is currently recruiting participants, and it's important for anyone considering joining to discuss it with their doctor to understand the benefits and any potential risks involved.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Biopsy proven adenocarcinoma of the prostate
• • Indication for ePLND combined with robot assisted radical prostatectomy (RARP) (MSKCC nomogram \>5%, if not applicable when only MRI targeted biopsies are positive, the Briganti nomogram will be used)
• • Suitable for robot-assisted ePLND and RARP
• • Mentally competent and understanding of benefits and potential burden of the study
• • Written informed consent
• • No known allergies for PSMA tracer.
• Exclusion Criteria:
• • History of prior diagnosed or treated PCa
• • Known concomitant malignancies (except Basal Cell Carcinoma of the skin)
• • Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RARP
• • PSMA non-avid PCa (local tumor activity)
• • Presence of distant metastasis (M1)