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Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Using PSMA PET/CT to guide surgery for prostate cancer

Official title: Preoperative PSMA PET/CT As Triage for Extended Pelvic Lymph Node Dissection (ePLND) in Patients Scheduled for Robot-Assisted Laparoscopic Radical Prostatectomy (RALP)

Run by Oslo University Hospital · NCT06398613 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment600 (estimated)
SponsorOslo University Hospital
Academic / other
Locations1 site (Oslo)
StatusRecruiting
StartedApril 26, 2024
Main results expectedDecember 31, 2029
Study endsDecember 31, 2029
Registry record updatedDecember 31, 2024
Trial IDNCT06398613 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men with biopsy-proven prostate adenocarcinoma who are classified as high-risk and require ePLND combined with RALP.

Probably not a fit

Patients with a history of previously treated prostate cancer or those with distant metastasis will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have shown promising results using PSMA PET/CT for staging prostate cancer, indicating potential success for this approach.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.