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PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores

Primary Purpose

Prostate Cancer, Recurrent Prostate Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
F-DCFPyL Injection
PSMA PET
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring radioactive diagnostic imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score >0.45).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
  • Previously enrolled to MCC#18523
  • Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen
  • Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (>0.45)
  • Treated with radical prostatectomy (RP) or radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up
  • Age > 18

Exclusion Criteria:

  • No follow up information available post treatment
  • Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
  • Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radioactive Diagnostic Imaging

Arm Description

Participants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access.

Outcomes

Primary Outcome Measures

Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings
To estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.

Secondary Outcome Measures

Rate of Positive PSMA-PET Findings
5-yr positive PSMA-PET findings in men with high GC score. At the end of the study (5 years), cumulative incidence of positive metastasis on PSMA-PET imaging will be calculated.

Full Information

First Posted
April 5, 2018
Last Updated
October 18, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Progenics Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03495427
Brief Title
PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores
Official Title
The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men With High GC Decipher® Test Scores: A Sub-aim of the VANDAAM Study (MCC #18523)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
Progenics Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score >0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.
Detailed Description
Normally, some patients with prostate cancer undergo imaging tests to determine the extent (spread) of their disease. These imaging tests often give good information, but not in all patients and not every time. This study deals with a new imaging test known as F-DCFPyL-Prostate-specific Membrane Antigen (PSMA) Positron Emission Tomography (PET), or F-DCFPyL-PSMA PET. The objective of this study is to evaluate safety and usefulness of using F-DCFPyL in detecting recurrent/metastatic prostate cancer. The F-DCFPyL PET imaging technique is used in some parts of the world but is not currently standard imaging care. Better understanding how this new imaging test performs in identifying recurrent/metastatic prostate cancer may lead to better management of prostate cancer patients in the future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Recurrent Prostate Cancer
Keywords
radioactive diagnostic imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radioactive Diagnostic Imaging
Arm Type
Experimental
Arm Description
Participants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access.
Intervention Type
Drug
Intervention Name(s)
F-DCFPyL Injection
Other Intervention Name(s)
Imaging agent
Intervention Description
F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.
Intervention Type
Diagnostic Test
Intervention Name(s)
PSMA PET
Other Intervention Name(s)
Prostate-specific Membrane Antigen (PSMA), Positron Emission Tomography (PET)
Intervention Description
PSMA PET imaging (for men with high GC >0.45) will be done after 2 years post-treatment, then yearly up to 5 years.
Primary Outcome Measure Information:
Title
Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings
Description
To estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Rate of Positive PSMA-PET Findings
Description
5-yr positive PSMA-PET findings in men with high GC score. At the end of the study (5 years), cumulative incidence of positive metastasis on PSMA-PET imaging will be calculated.
Time Frame
Up to 5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score >0.45). Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1 Previously enrolled to MCC#18523 Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (>0.45) Treated with radical prostatectomy (RP) or radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up Age > 18 Exclusion Criteria: No follow up information available post treatment Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angelina Fink
Phone
813-745-2588
Email
angelina.fink@moffitt.org
First Name & Middle Initial & Last Name or Official Title & Degree
Angelina Fink
Phone
Fax: 813-449-6672
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kosj Yamoah, M.D., Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kosj Yamoah, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Kenneth Gage, M.D., Ph.D.

12. IPD Sharing Statement

Links:
URL
https://www.moffitt.org/clinical-trials-research/clinical-trials/
Description
Moffitt Cancer Center Clinical Trials website

Learn more about this trial

PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores

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