tility of 18F-fluorocholine positron emission tomography in prostate cancer.

Phase 2

Recruiting

• Conditions: Cancer - Prostate; Prostate cancer

• Registration Number: ACTRN12608000641392
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Biopsy-proven prostate cancer;
Age = 18 years;
Written informed consent has been provided.
Newly-diagnosed prostate cancer (Staging Population):
Patient has not undergone any form of treatment for his disease;
Non-low risk disease. He must have at least one of the following features: prostate specific antigen (PSA) = 10.0 ng/ml within 8 weeks prior to randomisation; Gleason score = 7; clinical stage = T2b.
Suspected recurrent prostate cancer (Restaging Population):
Patient has undergone local radical treatment;
Within the 8 weeks prior to randomisation, the PSA level must be = 0.5 ng/ml and rising (post-operatively) or a PSA level of 2 ng/mL or more above the nadir PSA level (post-radiotherapy).

Exclusion Criteria

Participant has undergone, within 8 weeks prior randomisation, a diagnostic imaging(DI) procedure for the staging (N-staging or M-staging) or restaging of his prostate cancer;
A history of other active malignancy within the last 5 years, with exception of non-melanoma skin cancer;
Presently having androgen deprivation therapy started less than 6 months ago;
Where radical treatment of the patient would not be contemplated on the basis of limited expected lifespan due to comorbid conditions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: First-line imaging utility: change (or not) between management plan after the first-line imaging and management plan after second-line alternative imaging[Timepoint: within 8 weeks from randomisation<br>The primary endpoint will be assessed once. The data for the primary endpoint assessment will be collected after the first-line imaging for all participants, and after the second-line imaging for participants who have the second-line imaging performed. The staging or restaging process should be completed within 8 weeks.]