18F-DCFPyL PET/CT Impact on Treatment Strategies for Patients With Prostate Cancer (PROSPYL)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04390880|
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : April 8, 2021
The main purpose of this phase II trial study is to determine whether a positron emission tomography (PET)/computed tomography (CT) scan using 18F-DCFPyL affects the clinical management plan in Veterans.
In this study, the management plan prior to and after 18F-DCFPyL PET/CT will be recorded by specific questionnaires and corresponding changes in management will be analyzed. The scan will be used to see how the disease has spread. Both the treatment strategies and probable disease outcomes as relevant to clinical endpoints will be assessed. This study is open to Veterans only.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 18F-DCFPyL||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||IMPACT OF 18F-DCFPyL PET/CT ON INITIAL AND SUBSEQUENT TREATMENT STRATEGIES OF PATIENTS WITH PROSTATE CANCER (PROSPYL)|
|Actual Study Start Date :||April 7, 2020|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: PEt/CT arm
Subjects receive a PET/CT scan.
Study participants will receive intravenous administration of 18F-DCFPyL and undergo a PET/CT imaging study. Patients may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision.
- PRIMARY OBJECTIVES: I. To determine the impact of 18F-DCFPyL PET/CT on initial and subsequent treatment strategies of patients with prostate cancer. [ Time Frame: 2 years ]To determine the impact of 18F-DCFPyL PET/CT on initial and subsequent treatment strategies of patients with prostate cancer. This study uses questionnaires completed by the referring physician. A pre-scan questionnaire , a post-scan questionnaire and a follow-up questionnaire will be used to determine whether 18F-DCFPyL PET/CT affected intended treatment strategies and whether these intended treatment strategies were finally implemented.
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): NCT04390880
|Contact: Gholam Berenji, M.D.||310 268-3547||Gholam.Berenji@va.gov|
|United States, California|
|VA Greater Los Angeles Healthcare System||Recruiting|
|Los Angeles, California, United States, 90073|
|Contact: Alex Alas 310-478-3711 ext 41399 Alexander.Alas@va.gov|
|Contact: Gholam Berenji, M.D. 310 268-3547 Gholam.Berenji@va.gov|
|Principal Investigator: Gholam Berenji, M.D.|
|Principal Investigator:||Gholam Berenji, M.D.||Attending Physiscian|