Fluciclovine (18F) PET/CT in biochemical recurrence of prostate cancer
Research type
Research Study
Full title
A phase 3, open-label study to assess the clinical utility of Fluciclovine (18F) PET/CT in patients with prostate cancer with biochemical recurrence after radical treatment
IRAS ID
177789
Contact name
Fergus Gleeson
Contact email
Sponsor organisation
Blue Earth Diagnostics Limited
Eudract number
2015-000625-37
Duration of Study in the UK
2 years, 3 months, 21 days
Research summary
Prostate cancer is the commonest cancer in men. After curative treatment, recurrence can be detected by a blood marker, prostate specific antigen (PSA). When PSA rises, this is called biochemical recurrence (BCR), which occurs in 30% of patients.
If there is no known distant spread of cancer, second curative treatments (radical salvage) may be considered. Radical salvage treatment outcomes are better when given at low PSA levels. However, conventional imaging tests to show distant spread of cancer have low pick-up rates at such PSA levels. Determining cancer spread is important to ensure patients get appropriate treatment and avoid receiving unnecessary therapies (with potential side effects), and may inform doctors in planning radical salvage treatment.
Positron emission tomography-computed tomography (PET/CT) imaging is mainly used for detecting cancer. PET/CT using a new scanning agent fluciclovine (18F), has been shown to detect prostate cancer at low PSA levels, including where conventional imaging is normal. The purpose of this study is to find out how useful fluciclovine (18F) PET/CT is in planning the treatment of patients with BCR, intended for radical salvage therapy.
Fluciclovine (18F) PET/CT is performed in a three-hour visit. The result will be used to inform the final treatment plan, which will be compared to the intended treatment plan. On separate visits before and after PET/CT, participants will have blood, urine and heart tests.
The potential benefit to participants is that further information regarding their cancer status may be obtained, helping to direct their treatment. Participants will remain in the study up to 8 months after completing treatment. Recruitment will take place in several UK tertiary cancer referral centres.
This study is sponsored by Blue Earth Diagnostics Ltd and part-funded by Innovate UK (an executive non-departmental public body, sponsored by the Department for Business, Innovation & Skills of the UK Government).
REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0437
Date of REC Opinion
28 Aug 2015
REC opinion
Favourable Opinion