68Ga-RM2 compared to 68Ga-PSMA-617 PET/CT for prostate cancer imaging according to various metastatic risks UROPET”

Phase 1

• Conditions: Prostate cancer; MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2017-000490-36-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-27
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Patients prostate cancer
Candidate for radical prostatectomy after discussion in multidisciplinary committee
Covered by the national health insurance system
Written informed consent willingly obtained
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 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

Any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc…);
Patient not candidate for radical prostatectomy and/or unable to benefit from surgery
Freedom deprivated patient by judiciary or administrative decision
Patient under legal protection or unable to express its own consent
Patient within exclusion period from another clinical trial
Known contraindication to radiopharmaceuticals and / or excipients

Study & Design

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