FDHT - version 1, 9 March 2015
Research type
Research Study
Full title
[18F] DIHYDRO-TESTOSTERONE PET IMAGING IN PATIENTS WITH PROGRESSIVE PROSTATE CANCER
IRAS ID
156267
Contact name
Wim Oyen
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2014-005684-32
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is a Phase I trial to evaluate 18F-dihydrotestosterone (18F-FDHT) in patients with progressive prostate cancer. Dihydrostestosterone is the predominant form of testosterone in the prostate gland, which binds to the androgen receptor (AR). By labelling Dihydrostestosterone with the radioactive isotope 18F, we are able to perform a Positron Emission Tomography (PET) scan. Imaging with PET scanning has the potential to provide information regarding the presence and distribution of active tumour in the patient. In preliminary studies 18F-FDHT has been shown to bind to the AR and thus enable visualization of prostate cancer. The ability to visualize prostate cancers through the AR would be highly advantageous because the receptor remains functional even within a castrate environment. The ability to visualize treatment related changes in the AR pathway will allow not only confirmation of the biological effects of such agents but correlations to be made between these effects and clinical outcome. A non invasive method for measuring changes in the AR in metastatic prostate cancer would be particularly important for assessing the effects of drugs that act through or directly on the AR.
International interest in this tracer has been generated by preliminary data, the potential for 18F-FDHT to serve as a prognostic and predictive biomarker and its potential to demonstrate pharmacodynamic effects in drug development for AR target therapy, and we have received funds to better study the performance characteristics of the tracer. These include the tracer’s binding properties to its target, the reproducibility of the tracer and the impact of treatment on the tracer.
Patients taking part in this study will have up to four 18F-FDHT scans and up to three WB-MRI scans.REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0551
Date of REC Opinion
20 May 2015
REC opinion
Further Information Favourable Opinion