Mp-3TMRI and 68Ga-PSMA PET/CT Guided Prostate Biopsy and Tumor Node Metastasis (TNM) Staging.
NCT03465579 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 261
Last updated 2025-01-30
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.
Conditions
- 68Ga-PSMA PET/CT Guided Prostate Biopsy
- Mp-3TMRI Guided Prostate Biopsy
- Prostate Cancer
- TNM Staging
- Diagnosis
Interventions
- DIAGNOSTIC_TEST
-
pelvic MRI
multi-parametric pelvic MRI
- DIAGNOSTIC_TEST
-
68Ga-PSMA PET/CT
68Ga-PSMA PET/CT
Sponsors & Collaborators
-
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
lead OTHER
Principal Investigators
-
Federica Matteucci · IRST IRCCS
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-23
- Primary Completion
- 2024-09-03
- Completion
- 2024-09-03
Countries
- Italy
Study Locations
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