18F-DCFPyL PET-CT Scan and Prostate Cancer
February 21, 2019 updated by: Lida Jafari
A Novel 18F-DCFPyL PET-CT Scan for Diagnosis and Management of Prostate Cancer
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.
Study Overview
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 or equal to 4+3, or clinical stage greater than or equal to T2c).
Veterans who are planned to undergo or have recently undergone conventional, routine care initial staging scans for prostate cancer (99mTc-MDP or NaF PET bone scan and diagnostic CT or MRI of pelvis) will also receive a 18F-DCFPyL PET-CT scan.
The primary endpoint is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT scan identifies evidence of M1 disease at initial staging.
Study Type
Interventional
Enrollment (Anticipated)
170
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Los Angeles, California, United States, 90073
- Recruiting
- VA Greater Los Angeles
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Contact:
- Lida Jafari, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: treatment
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging
Time Frame: 120 days
|
120 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 22, 2018
Primary Completion (ANTICIPATED)
December 30, 2019
Study Completion (ANTICIPATED)
June 30, 2020
Study Registration Dates
First Submitted
February 21, 2019
First Submitted That Met QC Criteria
February 21, 2019
First Posted (ACTUAL)
February 25, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 25, 2019
Last Update Submitted That Met QC Criteria
February 21, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Jafari0001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.