Preoperative PSMA PET/CT As Triage for EPLND in Patients Scheduled for RALP (PrePSMA)

Launched by OSLO UNIVERSITY HOSPITAL · Apr 30, 2024

Keywords

ClinConnect Summary

The PrePSMA trial is studying whether a special imaging test called PSMA PET/CT can effectively replace a more invasive procedure known as extended pelvic lymph node dissection (ePLND) for staging prostate cancer in men who are scheduled to have surgery called robot-assisted laparoscopic radical prostatectomy (RALP). The goal is to see if this imaging test can provide the same important information about the cancer's spread without the need for surgery to remove lymph nodes.

To be eligible for this trial, participants must have a confirmed diagnosis of prostate cancer and be recommended for ePLND based on certain risk factors. They should also be able to give their written consent and have no known allergies to the imaging agent used. Those who have had prior prostate cancer treatments or have other serious cancers, as well as those who are unable to undergo the imaging or surgery, will not be included. Participants can expect to undergo the PSMA PET/CT scan and, if eligible, the planned surgery. This trial may help determine a safer and less invasive way to assess prostate cancer staging in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Biopsy proven diagnosed adenocarcinoma of the prostate
• * Indication for ePLND combined with RALP:
• • High-risk group (EAU) and including MRI findings indicating extra prostatic extension (Likert scale ≥4)
• • -ISUP GG 3 with ≥1 of the following unfavourable risk factors
• • cT2b-c,
• • ≥50% percentage of positive biopsy cores,
• • PSA 10-20
• • cN1 selected to surgery
• • Written informed consent
• • No known allergies for PSMA tracer
• • 18 years and older
• Exclusion Criteria:
• • History of previously actively treated PCa
• • Previous malignancies (except basal cell carcinoma of the skin) that has not been recurrence-free past ≥5 years
• • Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RALP
• • Presence of distant metastasis (cM1) on MRI imaging