NCT03465579

Mp-3TMRI and 68Ga-PSMA PET/CT Guided Prostate Biopsy and Tumor Node Metastasis (TNM) Staging.

Multi-cohort Investigational Study to Evaluate the Impact of Pelvic Mp-3TMRI and Whole-body 68Ga-PSMA PET/CT for Diagnosis of Clinically-significant Prostate Cancer and Pre-surgical Staging.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 261 (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

BIOPSTAGE is a prospective, non-randomized, diagnostic, multi-cohort investigational study to evaluate the impact of pelvic Multi-parametric 3-Tesla magnetic resonance imaging (mp-3TMRI) and whole-body 68Ga-PSMA PET/CT for diagnosis of clinically-significant prostate cancer and pre-surgical staging.

Detailed description

The aim of this study is to characterize the diagnostic accuracy of both multi-parametric pelvic Magnetic Resonance Imaging (MRI) (T2-weighted, Diffusion Weighted Imaging (DWI), Dynamic Contrast Enhancement (DCE) and 68Ga-chelated Prostate Specific Membrane Antigen ligand (68Ga-PSMA) Positron Emission Tomography/Computed Tomography (PET /CT) in three cohorts of patients: * COHORT 1 Guiding prostate biopsies in men with clinical suspicion and/or unconfirmed clinically-significant prostate cancer (CS-PCa) on initial prostate biopsy; * COHORT 2 Targeting repeat prostate biopsy in patients on Active Surveillance (PRIAS Study), scheduled for PRIAS repeat biopsy; * COHORT 3 Providing pelvic / whole-body pre-surgical staging in: * 3a: men with high-risk PCa (HR-PCa); * 3b: men candidates for nerve sparing surgery (NSS);

Conditions

• 68Ga-PSMA PET/CT Guided Prostate Biopsy
• Mp-3TMRI Guided Prostate Biopsy
• Prostate Cancer
• TNM Staging
• Diagnosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	pelvic MRI	multi-parametric pelvic MRI
DIAGNOSTIC_TEST	68Ga-PSMA PET/CT	68Ga-PSMA PET/CT

Timeline

• Start date: 2018-05-23
• Primary completion: 2024-09-03
• Completion: 2024-09-03
• First posted: 2018-03-14
• Last updated: 2025-01-30

Locations

2 sites across 1 country: Italy