Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers
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|ClinicalTrials.gov Identifier: NCT03585114|
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : March 29, 2019
- To determine whether changes in uptake of [18F]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria.
- To determine whether changes in uptake of [18F]DCFPyL PET/CT scans correlate with overall survival (OS)
- To determine whether baseline SUVmax correlate with rPFS
- To compare number of lesions detected with standard imaging at baseline and at the time of progression
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Prostate Cancer||Drug: [F-18] DCFPyL Procedure: PET/CT imaging||Phase 2|
Prostate cancer is the most common cancer and the third most common cause of cancer deaths in American men. The lethal form of the disease is metastatic castrate resistant prostate cancer (mCRPC). Serum prostate specific antigen (PSA) testing has been relied upon heavily as a marker of disease and is commonly used in the community to guide therapy.
PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. However, the role of [18F] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Fifteen men will be recruited from Columbia University Medical Center.|
|Masking:||None (Open Label)|
|Official Title:||Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers|
|Actual Study Start Date :||December 11, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Male participants diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and are scheduled to start a new treatment will receive [F-18] DCFPyL PET/CT imaging before starting new treatment and after 6 weeks on treatment.
Drug: [F-18] DCFPyL
[18F]DCFPyL will be used for study imaging. It will be administered intravenously on the day of imaging. Subjects will receive a bolus injection of 9mCi (331 MBq) of [18F]DCFPyL through a peripheral IV catheter. 60 to 120 minutes after injection, a whole body (toes to vertex) lowdose CT will be obtained (120 kVp, 80 mA maximum).
Other Name: [18F]DCFPyL (PyL)
Procedure: PET/CT imaging
As per standard of care, acquisition will be performed on PET/CT scanner (Siemens, Germany) operating in 3D emission mode with CT-derived attenuation correction.
Other Name: PET/CT acquisition
- Prevalence of changes in PyL PET imaging correlating with radiographic Progression-Free Survival (rPFS) [ Time Frame: Baseline, Post-treatment (approximately 6 weeks) ]To determine if changes in PyL PET/CT scans before and after 6 weeks on treatment is associated with stability of disease as measured by standard imaging.
- Prevalence of changes in uptake of [18F]DCFPyL PET/CT scans correlating with Overall Survival (OS) [ Time Frame: Baseline, Post-treatment (approximately 6 weeks) ]The percent difference in summed SUV between the first and second PET/CT will be noted.
- Prevalence of baseline SUVmax correlating with rPFS [ Time Frame: Baseline, Post-treatment (approximately 6 weeks) ]To determine if standardized uptake values (SUVs) at baseline is a good measure for patient evaluation.
- Change in number of lesions detected with standard imaging at baseline and at the time of progression [ Time Frame: Baseline, up to 1 year ]To compare lesions detected with standard imaging
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): NCT03585114
|Contact: Ana Serra||(212) firstname.lastname@example.org|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Bridget James|
|Principal Investigator: Emerson Lim, MD|
|Principal Investigator:||Emerson Lim, MD||Columbia University|