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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03465579 on ClinicalTrials.gov