PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer
2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-Amino]-Pentyl}-Ureido)-Pentanedioic Acid (PyL) in Patients With High Risk and Biochemically Recurrent Prostate Cancer
Study Overview
Detailed Description
This will be a phase II clinical trial to assess the clinical value of PyL for detection of disease in pateints with:
- High risk prostate cancer and planned prostatectomy or radiation therapy (arm 1) and
- Biochemically recurrent prostate cancer (arm 2) but without evidence of disease of standard of care imaging (CT of the chest/abdomen/pelvis and bone scan).
In both cohorts, PyL PET/CT will be obtained and evaluated by a nuclear radiologist trained in novel PET radiotracers, including PyL. Lesions suspicious for disease of PyL that were unsuspected on standard of care imaging will be selected for biopsy for pathologic confirmation if feasible . Pathology will be used as the reference standard for confirming malignancy.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
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Irvine, California, United States, 92618
- Recruiting
- Hoag Memorial Hospital Presbyterian
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male ≥ 18 years of age.
- Histologically confirmed adenocarcinoma of the prostate
- Patients meet one of the follow criteria:
Cohort 1: High risk prostate cancer (PSA >10, Gleason 8-10, or clinical stage >T2c) and planned prostatectomy or radiation therapy or Cohort 2: Biochemical prostate cancer relapse (Prostate Specific Antigen (PSA) > 0.2 ng/ml in patients following prostatectomy or ≥ 2 ng/ml more than the PSA nadir in patient following radiotherapy, as defined by the ASTRO-Phoenix criteria [18] and no evidence of malignancy on standard of care imaging for metastases (CT of the chest/abdomen/pelvis and bone scan) within 3 months.
Exclusion Criteria:
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
- Change in therapy since standard of care imaging
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: High risk prostate cancer
DCFPyL PET/CT will be compared to CT/bone scan for detection of unsuspected metastases in patients with high risk prostate cancer and planned prostatectomy or or radiation therapy
|
Prostate Membrane Specific Antigen-specific imaging
|
|
EXPERIMENTAL: Biochemically recurrent prostate cancer
DCFPyL PET/CT will be utilized for detection of unsuspected metastases in patients with biochemically recurrent prostate cancer, but with no evidence of disease on CT/bone scan.
|
Prostate Membrane Specific Antigen-specific imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of unsuspected metastases in high risk prostate cancer
Time Frame: up to 4 weeks
|
Determine the rate of detection of unsuspected metastases in patients with high risk prostate cancer and planned prostatectomy or radiation therapy.
|
up to 4 weeks
|
|
Detection of unsuspected metastases in biochemically recurrent prostate cancer
Time Frame: up to 4 weeks
|
Determine the rate of detection of unsuspected metastases in patients with biochemically recurrent prostate cancer, yet no evidence of disease on CT/bone scan.
|
up to 4 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
- 184-20-CA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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