High Precision Imaging of Prostate Specific Membrane Antigen for Personalized Treatment in Prostate Cancer

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Other: 68Ga-PSMA (HBED-CC) PET

• Registration Number: NCT03327675
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

This is an Investigator Initiated, non-commercial, single center, non-randomized, single arm, open label pilot study on 194 patients. The patients are affected by prostate cancer but in two different clinical settings. The first group is characterized by patients who are going to be operated of radical prostatectomy and they will undergo the study imaging preoperatively. The second group experiences biochemical relapse after primary treatment.

Detailed Description

Novel, sensitive tools, such as 68Ga-PSMA PET imaging, have great potential for very early disease detection and open the possibility of early curative local salvage treatment (with surgery, radiotherapy or a combination of both). This project will moreover provide important insights into the biodistribution and dosimetry of 68Ga-PSMA, opening possibilities of 90-Yttrium or 177-Lutetium-PSMA-based radionuclidetherapy of patients with metastatic PC in the future.

The study consists of 2 work units (WU):

Work-unit 1: Patients at high risk for nodal involvement prior to radical prostatectomy with extended lymph node dissection Work-unit 2: Biochemical recurrence after initial treatment with curative intent

Study Timeline

• Study First Submitted: 2017-07-10
• Study Start: 2017-09-22
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-10-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 188

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-PSMA PET/MR	68Ga-PSMA (HBED-CC) PET	Hybrid 68Ga-PSMA PET/MR scan

Primary Outcome Measures

Name	Time	Method
68Ga-PSMA PET/MR imaging accuracy before radical prostatectomy + pelvic lymph node dissection [RP + PLND]. Work unit 1. 68Ga-PSMA PET/MR imaging accuracy in patients with biochemical recurrence after primary treatment. Work unit 2.	through study completion, an average of 2 year	Assessment of the sensitivity, specificity, positive and negative predictive

Secondary Outcome Measures

Name	Time	Method
The correlation of tracer uptake to Gleason scores within the prostate tumor and within metastatic lymph nodes. Work unit 1.	through study completion, an average of 2 year	Correlation between tracer uptake and pathology Gleason score
Comparison of diagnostic accuracy between 68Ga-PSMA PET, MR and combined 68Ga-PSMA PET/MR. Work unit 2.	through study completion, an average of 2 year	Assessment of the sensitivity, specificity, positive and negative predictive value
The evaluation of change in patient management based on imaging results of 68Ga-PSMA PET/MR in patients with biochemical recurrence. Work unit 2.	through study completion, an average of 2 year	Proportion of patients with treatments different from follow-up after the evaluation of 68Ga-PSMA PET/MRI

Trial Locations

Locations (1)

UZLeuven; 🇧🇪 Leuven, Belgium