Diagnostic value of 64CuCl2-PET/MRI in prostate cancer relapse.

Phase 1

• Conditions: Prostate cancer patients who showed biochemical relapse after surgery or first-line treatment with radiotherapy; MedDRA version: 20.0Level: SOCClassification code 10038604Term: Reproductive system and breast disordersSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2014-005140-18-IT
• Lead Sponsor: ENTE OSPEDALIERO OSPEDALI GALLIERA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

-years > 18 (no upper age limit)
-all histologically proven prostate cancer patients who showed biochemical relapse after surgery or first-line treatment with radiotherapy
-Gleason score =6,
-increasing levels of PSA and PSA doubling time (DT) =6 months.
-Informed consent available

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

-comorbidity for other neoplasms
-inability to perform MRI
-known hypersensitivity to the substances or excipients contained in the tracers and contrast agent

Study & Design

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