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

NCT ID: NCT06398613

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-26

Study Completion Date

2029-12-31

Brief Summary

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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).

Detailed Description

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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

Conditions

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Prostate Cancer

Keywords

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PSMA PET/CT, ePLND

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RALP + ePLND Arm A

RALP + ePLND

Group Type NO_INTERVENTION

No interventions assigned to this group

RALP +/- ePLND Arm B

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.

Group Type EXPERIMENTAL

extended pelvic lymph node dissection (ePLND)

Intervention Type 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

Interventions

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extended 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Akershus

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Viktor Berge

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Viktor Berge

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Viktor Berge, PhD

Role: CONTACT

Phone: +4791599615

Email: [email protected]

Other Identifiers

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REK 688379

Identifier Type: -

Identifier Source: org_study_id