NCT03327675

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	68Ga-PSMA (HBED-CC) PET	68Ga-PSMA PET/MR

Timeline

• Start date: 2017-09-22
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2017-10-31
• Last updated: 2024-07-03

Locations

1 site across 1 country: Belgium