PET Acetate for Castrate-Resistant Prostate Cancer on Chemotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01144897|
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Castrate Resistant Prostate Cancer Prostate Cancer||Radiation: PET Acetate scan Drug: Carbon-11 labeled Acetate||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PET Acetate for Docetaxel Response Assessment in Hormone-Refractory Prostate Cancer|
|Actual Study Start Date :||May 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||September 2018|
Experimental: PET Acetate Imaging with Docetaxel
PET-acetate as an intermediate endpoint in the assessment of response of patients undergoing docetaxel for hormone refractory prostate cancer (HRPC).
Subjects will be treated with docetaxel, 75 mg/m2 every 21 days until disease progression or unacceptable toxicity occurs. Subjects will have two PET acetate scans - one prior to beginning chemotherapy and one approximately 8-9 weeks after chemotherapy has begun.
Radiation: PET Acetate scan
PET Acetate scans will be done to detect prostate cancer lesions.
Drug: Carbon-11 labeled Acetate
C-11 Acetate is a radiotracer used in PET scanning
Other Name: C-11 Acetate; Acetate
- Interpretation of PET Acetate scans [ Time Frame: Time of enrollment up to one year ]Standardized uptake values (mean and maximum SUVs) will be determined over the prostate bed and over any acetate-avid or CT-identified suspicious lesions. The change in these SUVs with treatment will be assessed, as well as the number of lesions. A blinded second reviewer from Nuclear Medicine will reviewed all baseline and response PET-acetate scans.
- Prostate cancer response to treatment and progression (excluding PET Acetate assessment) [ Time Frame: Time of enrollment up to two years ]Correlation with chemotherapy response
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): NCT01144897
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Daniel Vaena, MD||University of Iowa|