[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02297386|
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : August 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Localized Prostate Cancer||Drug: [18F] DIHYDRO-TESTOSTERONE Device: PET scan Device: MRI Other: Blood draw||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial Of [18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer|
|Actual Study Start Date :||November 2014|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
Experimental: [18F] DIHYDRO-TESTOSTERONE PET
The diagnostic intervention of this study is the use of FDHT PET in localized prostate cancer. Patients will undergo a 30 minute dynamic scan of the pelvis followed by a whole body scan of approximately 30-minutes duration. The dynamic scan will be optional, but strongly encouraged. PET scanning will preferably be done on the GE Discovery STE PET/CT scanner or the equivalent generation of scanner. The PET scans are routinely "quantitative," that is corrected for attenuation and scatter and adjusted for system sensitivity and providing parametric images in terms of standardized uptake values (SUV) (= μCi found/gm tissue / μCi injected/gm body mass).
Drug: [18F] DIHYDRO-TESTOSTERONE
Device: PET scan
Other: Blood draw
- increase in standardize uptake values (SUV) between the second and third FDHT scans [ Time Frame: 1 year ]Enrolling 15 patients will provide 80% power to detect a 33% increase in the mean uptake (from 6 to 8) between the 2nd and the 3rd scans.
- correlate AR expression to FDHT uptake [ Time Frame: 1 year ]involves collecting formalin fixed paraffin embedded tissue from pre-treatment biopsy specimens to correlate androgen receptor (AR) expression to FDHT uptake. AR expression will be measured using RNA-seq and correlated with FDHT SUV values separately for each scan using Spearman's rank correlation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297386
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Joseph Osborne, MD, PhD||Memorial Sloan Kettering Cancer Center|