NCT04775602

Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients with Prostate Cancer.

Experimental Study to Evaluate the Impact of 18F-PSMA PET / CT in the Management of Patients with Prostate Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.

Detailed description

Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer. The aim of this study is to evaluate the additional diagnostic role of 18F- PSMA PET /CT (sensitivity) in patients with prostate cancer with biochemical relapse compared to other diagnostic methods routinely used. The primary objective is to evaluate the sensitivity of 18F-PSMA PET/CT defined as the ratio between the number of 18F-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.Patients enrolled in the study would benefit from a more accurate but above all earlier diagnosis of disease recurrence sites, thus being able to undergo targeted therapies, with a clear impact on the clinical management of the disease.

Conditions

• 18F-PSMA
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	18F-PSMA	18F-PSMA will be injected intravenously at a dosage of 200-250 megabecquerel (MBq) prior to perform Image acquisition (Topogram, CT, PET)

Timeline

• Start date: 2020-07-31
• Primary completion: 2023-04-05
• Completion: 2024-07-11
• First posted: 2021-03-01
• Last updated: 2025-01-09

Locations

1 site across 1 country: Italy