18F-DCFPyL PET-CT Scan and Prostate Cancer
Status unconfirmed · Phase 2/Phase 3
Conditions studied: Prostate Cancer Adenocarcinoma
In brief
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 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. Secondary Objectives: Frequency of the change in primary treatment plan after initial staging.
Key facts
- Study ID
- NCT03852654
- Run by
- Lida Jafari
- People needed
- 170
- Starts
- 2018-07-22
- Expected to finish
- 2020-06-30
- Last updated by the study team
- 2019-02-25
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- VA Greater Los Angeles — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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