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

RECRUITINGN/ASponsored by Oslo University Hospital
Actively Recruiting
PhaseN/A
SponsorOslo University Hospital
Started2024-04-26
Est. completion2029-12-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06398613

Summary

Extended pelvic lymph node dissection (ePLND) is considered the gold standard for nodal staging in men with prostate cancer (PCa). The aim of this project is to determine if preoperative prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomograpy (CT) can safely replace ePLND as a staging method in PCa patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP).

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

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