Back to results18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer
Primary Purpose
Prostatic Neoplasms
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18F- DCFPyL PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostatic Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of prostate cancer
- PSA ≥ 0.2ng/ml
- Age ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (karnofsky ≥ 60%)
- Ability to understand and willingness to sign a written informed consent document
- Wiling to comply with clinical trial instructions and requirements
- Willing to cover the cost of PyL PET/CT imaging if funds are not available
Exclusion Criteria:
- History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
- Presence of prostate brachytherapy implants unless approved by the PI
- Administration of another radioisotope within five physical half-lives of trial enrollment
- Radiation or chemotherapy within 2 weeks prior to trial enrollment
- Serum creatinine > 3 times the upper limit of normal
- Serum total bilirubin > 3 times the upper limit of normal
- Aspartate transaminase (AST) or alanine aminotransferase (ALT) >5 times the upper limit of normal
- Inadequate venous access
Sites / Locations
- Columbia University Irving Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F- DCFPyL PET/CT
Arm Description
Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations including complete blood count (CBC), serum chemistries, hepatic panel, lactate dehydrogenase (LDH), and PSA. Liquid biopsies for circulating tumor DNA (ctDNA) and exosome analysis will occur at the same time. Subjects will then undergo 18F- DCFPyL PET/CT.
Outcomes
Primary Outcome Measures
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis
Secondary Outcome Measures
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis, with regions being the prostate or prostate bed, pelvis, extra pelvis, and bones
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis
To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis
To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03824275
Brief Title
18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer
Official Title
18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 12, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted PET imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. Its ability to image metastatic prostate cancer sites was comparable to 68Ga-PSMA with high tumor-to-background ratios.Additionally, [18F] PyL demonstrated higher mean tumor-to-background ratios when using kidney, spleen, or parotid as reference organs. However, the role of [18F] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.
Detailed Description
The investigators will conduct a prospective phase II/III study of 300 men diagnosed with prostate cancer with a rising prostate-specific antigen (PSA). Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations and undergo 18F- DCFPyL PET/CT.
[18F]DCFPyL will be used for study imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Prospective, non-randomized
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
18F- DCFPyL PET/CT
Arm Type
Experimental
Arm Description
Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations including complete blood count (CBC), serum chemistries, hepatic panel, lactate dehydrogenase (LDH), and PSA. Liquid biopsies for circulating tumor DNA (ctDNA) and exosome analysis will occur at the same time. Subjects will then undergo 18F- DCFPyL PET/CT.
Intervention Type
Drug
Intervention Name(s)
18F- DCFPyL PET/CT
Other Intervention Name(s)
CT scan
Intervention Description
A CT scan using a radioactive marker to better image tumors
Primary Outcome Measure Information:
Title
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis
Description
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis
Time Frame
3.5 years
Secondary Outcome Measure Information:
Title
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis, with regions being the prostate or prostate bed, pelvis, extra pelvis, and bones
Description
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis
Time Frame
3.5 years
Title
To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis
Description
To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis
Time Frame
3.5 years
Other Pre-specified Outcome Measures:
Title
To characterize ctDNA and exosomes in patients with prostate cancer
Description
To characterize ctDNA and exosomes in patients with prostate cancer
Time Frame
3.5 years
Title
To determine correlation with ctDNA and/or exosome levels with disease burden
Description
To determine correlation with ctDNA and/or exosome levels with disease burden
Time Frame
3.5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of prostate cancer
PSA ≥ 0.2ng/ml
Age ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (karnofsky ≥ 60%)
Ability to understand and willingness to sign a written informed consent document
Wiling to comply with clinical trial instructions and requirements
Willing to cover the cost of PyL PET/CT imaging if funds are not available
Exclusion Criteria:
History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
Presence of prostate brachytherapy implants unless approved by the PI
Administration of another radioisotope within five physical half-lives of trial enrollment
Radiation or chemotherapy within 2 weeks prior to trial enrollment
Serum creatinine > 3 times the upper limit of normal
Serum total bilirubin > 3 times the upper limit of normal
Aspartate transaminase (AST) or alanine aminotransferase (ALT) >5 times the upper limit of normal
Inadequate venous access
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew C. Dallos, MD
Organizational Affiliation
Assistant Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer
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