Prostate Cancer
Conditions
Keywords
PSMA PET/CT, ePLND
Brief 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).
Detailed description
Due to the latest change in EAU guidelines in May 2024, all eligible patients will undergo PSMA PET/CT. Patients will then be randomized between RALP and ePLND (Arm A) and RALP +/- ePLND (arm B): If PSMA PET/CT detect suspicious pelvic nodes, the patient will undergo ePLND concomitant with RALP. If PSMA PET/CT is negative, only RALP will be performed . Primary outcome measures: Difference in biochemical recurrence (BCR) rate between arm A and arm B within 2 years after initiation of primary treatment (BCR ≥ 0.2 ng/ml). Secondary outcome measures: Difference between Arm A and Arm B for surgical complications, persistent PSA after RALP and initiation of salvage therapy
Interventions
DIAGNOSTIC_TESTextended pelvic lymph node dissection (ePLND)
Prostate-Specific Membrane Antigen Emission Tomography/Computed Tomography (PSMA PET/CT) will done preoperatively in both arms of the study. In arm A all patients will undergo ePLND, in arm B only patients with positive PSMA PET/CT will undergo ePLND
Sponsors
University Hospital, Akershus
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between Arm A and Arm B in biochemical recurrence (BCR) rate between groups within 2 years after initiation of RALP | 2 years after initiation of primary treatment | BCR is defined as PSA ≥ 0.2 ng/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference between Arm A and Arm B in incidence and types of surgical complications | 3 months follow up | Clavien Dindo classification of complications will be used |
| Difference between Arm A and Arm B in persistent PSA after RALP | 2 months after RALP | If the PSA value 6 weeks postoperatively is \> 0.10 ng/ml the patient has persistent PSA |
| Difference between Arm A and Arm B in initiation of salvage therapy | 2 years follow up | Salvage therapy is salvage radiation therapy, salvage surgery and ADT |
Countries
Norway
Contacts
Primary ContactViktor Berge, PhD
Outcome results
None listed