Using PSMA PET/CT to guide surgery for prostate cancer
Preoperative PSMA PET/CT As Triage for Extended Pelvic Lymph Node Dissection (ePLND) in Patients Scheduled for Robot-Assisted Laparoscopic Radical Prostatectomy (RALP)
This study is testing if a special imaging scan can help guide surgery for prostate cancer patients instead of a more invasive procedure, to see if it leads to better outcomes after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06398613 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether preoperative prostate specific membrane antigen (PSMA) PET/CT can replace extended pelvic lymph node dissection (ePLND) as a staging method for prostate cancer patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Eligible patients will undergo PSMA PET/CT and will be randomized into two groups: one receiving RALP with ePLND if suspicious nodes are detected, and the other receiving only RALP if no suspicious nodes are found. The primary outcome is to compare the biochemical recurrence rates between the two groups within two years post-treatment.
Who should consider this trial
Good fit: Ideal candidates include men with biopsy-proven prostate adenocarcinoma who are classified as high-risk and require ePLND combined with RALP.
Not a fit: Patients with a history of previously treated prostate cancer or those with distant metastasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for invasive surgeries while maintaining effective cancer staging.
How similar studies have performed: Other studies have shown promising results using PSMA PET/CT for staging prostate cancer, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Viktor Berge — Oslo University Hospital
- Study coordinator: Viktor Berge, PhD
- Email: vikber@ous-hf.no
- Phone: +4791599615
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.