None listed
Conditions
Brief summary
Prostate cancer can extend beyond the prostate, most commonly to lymph nodes or bones. Determination of its extent is crucial to determining best treatment options for patients. Currently, the conventional tests that are most commonly used for this purpose are a bone scan and computed tomography but these are not very accurate and may result in inappropriate treatment. Positron emission tomography with fluorocholine (FCH-PET/CT) is a promising new test for diagnosing the extent of prostate cancer since it can detect disease in the prostate itself, lymph nodes, and bones. This project proposes to compare the utility of FCH-PET/CT with that of conventional tests for guiding treatment decisions. Patients who have a newly diagnosed prostate cancer, or in whom a relapse of prostate cancer is suspected will be randomly assigned to undergo either conventional tests or FCH-PET/CT as the initial investigation. If these show no distant spread, patients will undergo the alternative test strategy. The usefulness of each test strategy will be assessed by its influence on treatment planning. It is anticipated that FCH-PET/CT will better identify the patients who are amenable to a curative treatment and avoid futile treatments in some other patients. If FCH-PET/CT, a new and non-invasive test, proves successful, it is likely to become more widely available to patients with prostate cancer.
Interventions
Positron emission tomography/computed tomography with 18F-fluorocholine (FCH-PET/CT)
Positron emission tomography (PET) is a nuclear medicine imaging modality using radiopharmaceuticals labelled with positron emitting isotopes (such as fluorine-18), aimed at imaging various metabolic processes in vivo. Newer PET scanners are always combined with a computed tomography scanner (PET/CT), allowing combination of PET images with anatomical CT images in order to localize precisely any PET abnormality
Positron emission tomography/computed tomography with 18F-fluorocholine (FCH-PET/CT) Positron emission tomography (PET) is a nuclear medicine imaging modality using radiopharmaceuticals labelled with positron emitting isotopes (such as fluorine-18), aimed at imaging various metabolic processes in vivo. Newer PET scanners are always combined with a computed tomography scanner (PET/CT), allowing combination of PET images with anatomical CT images in order to localize precisely any PET abnormality. 18F-fluorocholine (FCH) is a PET radiopharmaceutical for imaging the metabolism of choline, a precursor of cell membranes, which is increased in tumoural cells with high cell membrane turnover, such as prostate cancer cells. The participant is given an injection of FCH prior to PET/CT scanning. Participants will receive between 1 and 3 trial scans (CT+WBBS and/or FCH-PET/CT), as first and second-line imaging modalities. Then 6 months following the completion of treatment (of maximum 6 months duration), or after 12 months surveillance, participants will receive between 1 and 3 follow-up scans. Those patients who receive long term hormonal treatment will not receive mandated follow-up scans Patients are randomized to either 18F-fluorocholine positron emission tomography/computed tomography (FCH-PET/CT) or Conventional Imaging (CI)which is a combination of computed tomography (CT) and whole-body bone scan (WBBS). The randomized group determines which modalit(ies) (FCH-PET/CT or CI) the participant will have as the first-line imaging work-up. Then, the participants will receive the alternate imaging (CI or FCH-PET/CT) as a second-line imaging work-up if the first-line was negative/equivocal for distant metastasis. This study is a diagnostic trial and does not involve any therapeutic intervention. Participant’s care is managed by the treating physician, as it would normally be if the participant were not participating in the study.
Sponsors
Peter MacCallum Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed