A randomised trial comparing 18F-fluorocholine positron emission tomography/computed tomography (FCH-PET/CT) with Conventional Imaging (computed tomography and whole-body bone scan) with respect to their first-line utility in the staging or restaging of patients with prostate cancer.

Peter MacCallum Cancer Centre0 sites100 target enrollmentDecember 17, 2008

Overview

No summary available.

Registry

who.int

Start Date

December 17, 2008

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

Male

Sponsor

Peter MacCallum Cancer Centre

•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).

•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.