Status:
UNKNOWN
18F-DCFPyL PET-CT Scan and Prostate Cancer
Lead Sponsor:
Lida Jafari
Collaborating Sponsors:
University of California, Los Angeles
Conditions:
Prostate Cancer Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Primary Objective: 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 bo...
Detailed Description
This is a single arm Phase II clinical trial in Veterans with prostate cancer, no prior local therapy, who are at risk of having metastatic disease (PSA greater than 10, or Gleason Score greater than ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years and male.
- Ability to understand the study and the willingness to sign a written informed consent document.
- Histologically confirmed adenocarcinoma of the prostate.
- PSA greater than 10, or Gleason ≥4+3, or clinical stage greater than or equal toT2c.
- Plan to undergo (or have already undergone) routine care initial systemic staging with conventional imaging for prostate cancer.
- Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
- No prior local therapy for prostate cancer (i.e., prostatectomy, radiotherapy, etc.).
- Willing to comply with the procedural requirements of this protocol.
Exclusion
- Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
- The subject has a condition or situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study.
- Primary small cell carcinoma of the prostate.
- Participation in this study significantly delay the scheduled standard of care therapy.
- Weighs greater than 350 lbs., or unable to fit within the imaging gantry.
- The subject undergone prior local therapy for prostate cancer (i.e. prostatectomy, radiotherapy, etc.).
- Currently receiving androgen deprivation therapy (ADT) or anti-androgen? Previous use of ADT is allowed IF the subject has been off ADT or anti-androgen for 3 months or more.
Key Trial Info
Start Date :
July 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2020
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT03852654
Start Date
July 22 2018
End Date
June 30 2020
Last Update
February 25 2019
Active Locations (1)
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1
VA Greater Los Angeles
Los Angeles, California, United States, 90073