Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06398613
Other study ID # REK 688379
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 26, 2024
Est. completion date December 31, 2029

Study information

Verified date May 2024
Source Oslo University Hospital
Contact Viktor Berge, PhD
Phone +4791599615
Email vikber@ous-hf.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

Eligible for the study is patients scheduled for RALP and ePLND according to current practice. Patients will be randomized between RALP and ePLND (Arm A) and PSMA PET/CT (arm B). If PSMA PET/CT detect suspicious pelvic nodes, the patient will undergo ePLND comcomitant 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


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 31, 2029
Est. primary completion date December 31, 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Biopsy proven newly diagnosed adenocarcinoma of the prostate - Indication for ePLND combined with RALP (Briganti 2019 nomogram risk >7%) - Written informed consent - No known allergies for PSMA tracer Exclusion Criteria: - History of prior diagnosed or treated PCa - Known concomitant malignancies (except Basal Cell Carcinoma of the skin) - Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RALP - If MRI shows distant metastasis to non-regional lymph nodes (M1a) or bone metastasis (M1b) on MRI imaging

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
PSMA PET/CT
Prostate-Specific Membrane Antigen Emission Tomography/Computed Tomography (PSMA PET/CT) will done preoperatively

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary Difference between Arm A and Arm B in persistent PSA after RALP If the PSA value 6 weeks postoperatively is = 0.10 ng/ml the patient has persistent PSA 6 weeks after RALP
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT01331083 - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06305832 - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer Phase 2
Recruiting NCT05761093 - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A