18F-DCFPyL PET-CT Scan and Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03852654|
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
The primary objective of this study is to assess the efficacy of 18F-DCFPyL PET-CT for initial staging of prostate cancer in Veterans compared to conventional imaging (99mTc-MDP bone scan and Diagnostic CT or MRI). The primary clinical endpoint of our study is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging.
Frequency of the change in primary treatment plan after initial staging.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Adenocarcinoma||Drug: 18F-DCFPyL||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Novel 18F-DCFPyL PET-CT Scan for Diagnosis and Management of Prostate Cancer|
|Actual Study Start Date :||July 22, 2018|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||June 30, 2020|
Subjects with biopsy proven prostate cancer, no prior local therapy, and:
PSA ≥ 10 ng/dl, or Gleason Sum ≥ 4+3, or clinical stage ≥cT2c Staging by 99mTc-MDP or NaF PET bone scan, and Diagnostic CT (pelvis) or MRI will undergo 18F DCFPyL PET CT scan.
- the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging [ Time Frame: 120 days ]
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): NCT03852654
|Contact: Jafari Lida, M.D.||310 268 email@example.com|
|Contact: Nicholas G Nickols, M.D., Ph.D.||310 268 firstname.lastname@example.org|
|United States, California|
|VA Greater Los Angeles||Recruiting|
|Los Angeles, California, United States, 90073|
|Contact: Lida Jafari, M.D.|