NCT03183544

Dosimetry and Safety Phase 1 Study With 68Ga-PSMA-11 Sterile Cold Kit

Kinetics, Biodistribution, Dosimetry and Safety Phase 1 Study With 68Ga-PSMA-11 Sterile Cold Kit, in Healthy Male Volunteers and Patients With Limited Recurrent Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Prostate cancer is the most common cancer in men. Early detection of primary diseases and recurrence is crucial for patient counseling and management. Conventional imaging modalities (CT-MRI) are limited to detect recurrence. Choline-based PET/CT is currently widely used as primary staging tool in prostate cancer and in patients with suspicious recurrent disease. Compared to choline-based tracers, 68Ga-PSMA ligands have been shown to have a higher diagnostic efficacy and to increase the detection of metastases even at low PSA levels. The most widely used prostate-specific membrane antigen (PSMA) ligand is PSMA-11. A supplier, ANMI, has developed a kit formulation of PSMA-11 which will be test in this clinical trial.

Detailed description

Prostate cancer represents the most common cancer in men and accounts for the third most common cancer death in men. Up to 50% of all patients undergoing radical prostatectomy or radiotherapy for primary treatment of prostate cancer develop biochemical recurrence. Early detection of primary diseases and recurrence is crucial for patient counseling and management. Conventional imaging modalities such as computed tomography (CT) or magnetic resonance imaging (MRI) are limited because they focus on morphologic information such as lymph node size and tissue structure. Positron emission tomography/computed tomography (PET/CT) is a hybrid imaging technique combining functional and morphological information. Choline-based PET/CT is currently widely used as primary staging tool in prostate cancer and in patients with suspicious recurrent disease. Compared to choline-based tracers, 68Ga-PSMA ligands have been shown to have a higher diagnostic efficacy and to increase the detection of metastases even at low PSA levels. The most widely used prostate-specific membrane antigen (PSMA) ligand is PSMA-11. A supplier, ANMI, has developed a kit formulation of PSMA-11 which can be labeled at room temperature by direct incubation of the kit with the gallium-68 eluted from a 68Ge/68Ga generator.

Conditions

• Prostatic Neoplasm

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit	The patients will receive a single injection of Gallium-68 PSMA-11 to diagnose biochemical relapse of prostate cancer after treatment.

Timeline

• Start date: 2019-01-24
• Primary completion: 2020-02-24
• Completion: 2020-02-24
• First posted: 2017-06-12
• Last updated: 2020-10-26

Locations

1 site across 1 country: Belgium