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| Name | Class |
|---|---|
| University Hospital, Akershus | OTHER |
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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RALP + ePLND Arm A | No Intervention | RALP + ePLND | |
| RALP +/- ePLND Arm B | Experimental | I preoperative PSMA PET/CT is positive for pelvic nodal metastasis, ePLND concomitant with RALP will be performed. If PSMA PET/CT is negative, only RALP will be done. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extended pelvic lymph node dissection (ePLND) | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between Arm A and Arm B in biochemical recurrence (BCR) rate between groups within 2 years after initiation of RALP | BCR is defined as PSA ≥ 0.2 ng/ml | 2 years after initiation of primary treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between Arm A and Arm B in incidence and types of surgical complications | Clavien Dindo classification of complications will be used | 3 months follow up |
| Difference between Arm A and Arm B in persistent PSA after RALP |
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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
cN1 selected to surgery
Written informed consent
No known allergies for PSMA tracer
18 years and older
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viktor Berge, PhD | Contact | +4791599615 | vikber@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Viktor Berge | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | 4950 | Norway |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
If the PSA value 6 weeks postoperatively is > 0.10 ng/ml the patient has persistent PSA
| 2 months after RALP |
| Difference between Arm A and Arm B in initiation of salvage therapy | Salvage therapy is salvage radiation therapy, salvage surgery and ADT | 2 years follow up |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |