- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03976843
Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer
A Phase II Multi-Institutional Trial to Evaluate Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer
Background:
People with prostate cancer usually have their cancer imaged with a CT scan and bone scan. They then have their prostate gland removed. Researchers want to test a scan that might predict if prostate cancer will return after this surgery.
Objective:
To test if a PET/CT scan before the prostate gland is removed can predict if prostate cancer will return. Also, to test if this approach is better or worse than the usual approach for prostate cancer.
Eligibility:
Men ages 18 and older with prostate cancer that appears to be contained within the prostate but is at risk of having spread
Design:
Participants will be screened with:
- Medical history
- Blood tests
- CT and MRI scans: Participants will lie in a machine. The machine will take pictures of the body.
- Bone scan
Participants will have a radiotracer injected into a vein. They will have a PET/CT scan of their whole body 60 90 minutes later. During the scan, they will lie on their back and stay still.
Within 60 days after the scan, participants will have surgery. This will remove the prostate gland and lymph nodes around it. Some tissue will be used for genetic testing.
If the PET/CT scan suggests the cancer has spread, participants may need to have another biopsy within 60 days after the scan.
After surgery, participants will have follow-up visits for 5 years. They will have 5 visits the first year and 2 the second. Then they will have visits once a year.
If participants cancer returns, they will have repeat PET/CT scans.
Study Overview
Detailed Description
Background:
- About 30,000 men will die from prostate cancer in the US in 2018. The majority of these men originally presented with localized cancer.
- Treatment options for patients with high risk, localized disease typically involve radical prostatectomy (RP) or radiation therapy (RT) in combination with androgen deprivation therapy (ADT). Following RP, 70% of patients with high-risk disease will experience a biochemical recurrence at 5 years, and approximately 20% will die of their disease in 10-15 years, likely due to metastatic disease that was not detectable using conventional imaging (99mTc-methylene diphosphonate bone scan and X-ray computed tomography) at
the time of prostatectomy.
- Prostate-specific membrane antigen (PSMA) is commonly expressed in prostate cancers and is associated with biologic aggressiveness.
- The second generation, PET tracer 18F-DCFPyl binds to the enzymatic portion of PSMA. It exhibits high uptake in tumor and rapid washout in normal tissues leading to high tumor to background ratios and the possibility of detecting metastases when conventional imaging is negative.
Objective:
-To determine if patients with a preoperative 18F-DCFPyL PET/CT that is negative for metastases experience 5 year progression free survival (PFS) which is improved (40%) over that of historical data (30%) based on a general population of similar patients who have not undergone imaging with 18F-DCFPyL PET/CT
Eligibility:
- Men greater than or equal to 18 years of age at the time of providing informed consent.
- Patients must have histologically proven prostate adenocarcinoma confirmed by a CLIA certified laboratory
- Eastern Cooperative Oncology Group (ECOG) performance status: less than or equal to 2.
Must have prostate cancer with high risk features defined as:
- Gleason 8 and higher OR
- PSA > 20 ng/mL OR
- Clinical stage T3a (i.e. likely extraprostatic extension on MRI) or T3b
Laboratory parameters:
- Hemoglobin >= 9 g/dL
- Leukocytes >=3,000/mcL
- Platelets >=100,000/mcL
- Total bilirubin <2 X normal institutional limits
- AST(SGOT)/ALT(SGPT) less than or equal to 3 X normal institutional limits
- Creatinine <2 X normal institutional limits OR
- eGFR >=50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (calculated via the MDRD equation)
- Patients must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT.
- Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT
Design:
- This is an open-label, non-randomized, multi-center trial designed to evaluate the impact of 18F-DCFPyL PET/CT imaging on Progression-Free Survival at 5 years in patients with high risk localized prostate cancer.
- All subjects meeting eligibility criteria will undergo baseline assessments to include multiparametric MRI of the prostate, 99mTc-methylene diphosphonate bone scan and contrast-enhanced CT of the abdomen and pelvis.
- All subjects meeting eligibility criteria will undergo 18F-DCFPyL PET/CT.
- The study will enroll up to 200 patients from 7 centers. Up to 40 patients will be enrolled at NCI.
- All subjects will undergo radical prostatectomy and lymphadenectomy within 60 days following PET/CT imaging.
- Subjects will be evaluated at 6 weeks, at 3, 6, 9, 12, and 18 months, at 2, 3, 4, and 5 years post-prostatectomy to determine if there has been progression and to record details of subsequent treatment and response.
- 18F-DCFPyL PET/CT imaging will be repeated at the time of progression.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Fatima H Karzai, M.D.
- Phone Number: (301) 480-7174
- Email: fatima.karzai@nih.gov
Study Contact Backup
- Name: Michele L Reed, R.N.
- Phone Number: (240) 760-6121
- Email: michele.reed@nih.gov
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- Recruiting
- University of California, San Francisco
-
Contact:
- Imelda Tenggara
- Phone Number: 415-353-7348
- Email: imelda.tenggara@ucsf.edu
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112-2699
- Recruiting
- Tulane University
-
Contact:
- Charlotte Manogue
- Phone Number: 504-988-3908
- Email: cmanogue@tulane.edu
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Recruiting
- Johns Hopkins University
-
Contact:
- Rana Harb
- Phone Number: 410-502-5500
- Email: r-harb1@jhmi.edu
-
Bethesda, Maryland, United States, 20892
- Recruiting
- National Institutes of Health Clinical Center
-
Contact:
- For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
- Phone Number: 888-624-1937
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham and Women s Hospital
-
Contact:
- Isabella Izidoro
- Phone Number: 617-525-8710
- Email: Isabella_Izodoro@DFCI.HARVARD.EDU
-
-
New York
-
New York, New York, United States, 10021
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Emma Zulch
- Phone Number: 646-888-1331
- Email: zulche@mskcc.org
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107-6541
- Recruiting
- Thomas Jefferson University
-
Contact:
- Christine Hubert
- Phone Number: 215-955-9954
- Email: christine.hubert@jefferson.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
- INCLUSION CRITERIA:
- Patients must have histologically proven prostate adenocarcinoma confirmed by a CLIA certified laboratory.
Must have prostate cancer with high risk features defined as:
- Gleason 8 and higher OR
- PSA > 20 ng/mL OR
- Clinical stage T3a (i.e. likely extraprostatic extension on MRI) or T3b
- Patients must be eligible for and must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT
- Men age greater than or equal to 18 years.
- ECOG performance status <2
Patients must have adequate organ and marrow function as defined below:
- Hemoglobin greater than or equal to 9 g/dL
- leukocytes greater than or equal to 3,000/mcL
- platelets greater than or equal to 100,000/mcL
- total bilirubin <2 X normal institutional limits
- AST(SGOT)/ALT(SGPT) less than or equal to 3 X normal institutional limits
- creatinine <2 X normal institutional limits
OR
eGFR greater than or equal to 50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Willingness and ability to undergo biopsy of radiotracer-avid lesion if feasible.
- Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT
EXCLUSION CRITERIA:
- Any investigational agents in the past 28 days prior to enrollment.
- Clinical stage T4 (tumor invades adjacent structures except seminal vesicles).
- Distant metastatic disease on conventional imaging studies (computed tomography (CT)) of the abdomen and pelvis and bone scan. NaF PET/CT scan cannot substitute for a bone scan. Given lack of specificity of CT for lymph node metastases at lower thresholds, pelvic lymph nodes below 2 cm in the short axis are allowed.
- Any prior hormone therapy used to treat prostate cancer, except limited androgen receptor antagonist therapy, defined as less than or equal to 3 days of treatment. The medication must be discontinued within 5 half-lives of the compound prior to study entry.
- Any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy.
Contraindication to MRI or PET:
- Patients weighing more than weight limit for the scanner tables or unable to fit within the imaging gantry
- Prior reaction to 18F-DCFPyL
- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device that are not MRI compatible at 3 T
- Severe claustrophobia unresponsive to oral anxiolytics
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for the protocol procedures or for radical prostatectomy.
- A malignancy within the past 3 years for which prostatectomy is a contraindication.
- Radiotracer administered within 5 half-lives prior to the date of 18F-DCFPyL PET/CT imaging.
- PSMA-targeted imaging within 6 months with 18F-DCFPyL tracer prior to the date of 18F-DCFPyL PET/CT imaging. Participants can have PSMA targeted imaging with Gallium.
- Unable to refrain from fathering a child or donating sperm for 10 days after each 18FDCFPyL injection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1/18F-DCFPyL PET/CT + radical prostatectomy
18F-DCFPyL PET/CT with radical prostatectomy and lymphadenectomy
|
18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression free survival
Time Frame: 6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years
|
progression-free survival which is improved over that of historical data from a general population
|
6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression free survival
Time Frame: 6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years
|
progression-free survival of patients with an 18F-DCFPyL PET/CT that is positive for metastases
|
6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fatima H Karzai, M.D., National Cancer Institute (NCI)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190104
- 19-C-0104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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