PET/MRI in patients with suspected prostate cancer

Phase 1

• Conditions: Clinical suspected prostate cancer; MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2014-004758-33-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-04
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

•Clinical suspicion of prostate cancer:
•blood PSA level > 4.0 ng/ml and/or
•free-to-total PSA ratio <22% and/or
•progressive rise of PSA levels in two consecutive blood samples despite antibiotics

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 165

Exclusion Criteria

•antiandrogen therapy
•prostate needle biopsy <21 days before PET/MRI
•known active secondary cancer
•endorectal coil not applicable (e.g. anus praetor with short rectal stump)
•known active prostatitis (e.g. painful DRE)
•known anaphylaxis against gadolinium-DTPA
•patient’s written informed consent not given

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified