Role of PET/ CT with 18F-fluorocholine in the staging of patients with intermediate/high risk prostate cancer.

Phase 1

Conditions: Histologically proven prostate cancer with Gleason score =7 and PSA>=10ng/ml or Gleason score >=8 and any PSA level or cT2-T3 and any PSA level or any Gleason score and PSA>=20ng/ml and indication of prostactectomy, radiotherapy or systemic therapy
MedDRA version: 14.1Level: PTClassification code 10060862Term: Prostate cancerSystem 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: EUCTR2013-002511-99-IT

Lead Sponsor: ISTITUTO ONCOLOGICO VENETO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 390

Inclusion Criteria

Histologically proven prostate cancer with Gleason score =7 and PSA>=10ng/ml or Gleason score >=8 and any PSA level or cT2-T3 and any PSA level or any Gleason score and PSA>=20ng/ml

Age more than 18 years
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 290

Exclusion Criteria

Metastatic disease

Patients treated with anti-androgen therapy or radiotherapy

Previous malignancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Verify whether the additional use of PET/CT with 18F-fluorocholine in the initial staging of prostate cancer improves the sensitivity in defining the loco-regional disease with respect to CT and bone scan.;Secondary Objective: To show whether the use of PET / CT with 18F-fluorocholine modifies the therapeutic approach regarding the use of surgical treatment and / or systemic therapy, evaluate the toxicity of 18F-fluorocholine and the cost-effectiveness of the additional use of PET / CT with 18F-fluorocholine.;Primary end point(s): sensitivity of PET/TC 18F-fluorocholine in defining the loco-regional disease ;Timepoint(s) of evaluation of this end point: Up to 180 days since randomization

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) number of patients undergoing surgery or systemic therapy in each study arm<br>2) toxicity measured with the National Cancer Institute Common Terminology Criteria for Adverse Events v4 System<br>3) costs of diagnostic methods and absolute risk reduction for a futile surgery obtained using PET/TC 18F-fluorocholine;Timepoint(s) of evaluation of this end point: Up to 180 days since randomization