[11C]-choline PET/CT imaging in prostate cancer patients

• Conditions: Prostate adenocarcinoma accounts for 11% of all malignancies, with a total 2.6 million new cases / year estimated in Europe. Mortality rate is 30.6 / 100,000 persons/year. Prostate cancer generally evolves relatively slow and as a result of local growth, the tumor may infiltrate the closest pelvic structures; besides the frequent metastatic involvement of pelvic lymph nodes, this cancer can metastasize through the bloodstream, with a marked preference for the skeleton.; MedDRA version: 14.1Level: LLTClassification code 10066489Term: Progression of prostate cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001330-17-IT
• Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-02
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

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

Inclusion Criteria

Patients included must meet the inclusion criteria as follow:
we will enroll adult patients (aged>18years) with prostate cancer and suspected skeletal metastasis referring us at the Nuclear Medicine Unit, IRCCS AOU San Martino - IST for specialist evaluation and that have signed the informed consent for study participation.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

The present study will not include healthy volunteers. Likewise, patients affected by conditions requiring emergency treatment, underage, mentally incapable or those who refuse to sign the informed consent will be excluded from the study.

Study & Design

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