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Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18F-DCFPyL Injection
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring 18F-DCFPyL PET/CT PyL, PSMA

Eligibility Criteria

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

Inclusion Criteria:

  • Histological confirmation of prostate cancer
  • Patients receiving androgen deprivation treatment (ADT) with GnRH analogs, GnRH antagonists or bilateral orchiectomy of any duration.

  • Cohort A: nmCRPC (status post- primary treatment with radical prostatectomy, radiation of any type or both)

    • Negative 99mTc-methylene diphosphonate bone scan and CT of the chest abdomen and pelvis within 6 weeks of 18F-DCFPyL PET/CT
    • Treatment with ADT with or without a second line novel AR targeted treatment (abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted) for ≥ 12 months.
    • Rising PSA ≥ 10 ng/ml (confirmed by 2 determinations one week apart)
    • PSADT ≤ 9 months

  • Cohort B: mCRPC

    • Treatment with ADT with or without abiraterone and or enzalutamide or both for ≥ 6 months and/or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted).
    • PSA ≥ 2.0 ng/ml confirmed X 1 week apart, any PSADT
  • Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility.
  • No new therapeutic interventions planned or scheduled to be instituted prior to the course of this study both on cohorts A and B before conventional radiologic progression is evidenced.
  • Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

  • Patient will be excluded from enrollment if he had a radioisotope within 5 physical half-lives prior to PET imaging

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DCFPyL Injection

Arm Description

A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

Outcomes

Primary Outcome Measures

Sensitivity 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer
Proportion of patients demonstrating disease progression by conventional criteria evaluated by CT scan and 99mTc-methylene diphosphonate bone scan and on 18F-DCFPyL PET/CT.

Secondary Outcome Measures

Correlation of findings on 18F-DCFPyL PET/CT with conventional imaging as determined by Number of Lesions detected on each imaging modality
Number of lesions detected on 18F-DCFPyL PET/CT in comparison to number of lesions detected on conventional imaging (99mTc-methylene diphosphonate bone scan and CT)

Full Information

First Posted
January 9, 2019
Last Updated
December 14, 2021
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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1. Study Identification

Unique Protocol Identification Number
NCT03800784
Brief Title
Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
Official Title
Study of 18F-DCFPyL PET/CT, for Detection of Radiological Progression in Patients With Metastatic (M+) and Non-metastatic (M0) Castration Resistant Prostate Cancer Receiving Standard Androgen Receptor Targeted Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 21, 2021 (Actual)
Study Completion Date
October 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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
This study evaluates the rate of radiological disease progression with the new 2nd generation positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, in patients with metastatic castration (mCRPC) and non-metastatic (nmCRPC) castration resistant prostate cancer who have evidence of biochemical (PSA) disease progression without evidence of radiological disease progression on conventional standard radiologic testing (99mTc-methylene diphosphonate bone scan and CT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
18F-DCFPyL PET/CT PyL, PSMA

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
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-DCFPyL Injection
Arm Type
Experimental
Arm Description
A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
Intervention Type
Drug
Intervention Name(s)
18F-DCFPyL Injection
Other Intervention Name(s)
PyL
Intervention Description
A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
Primary Outcome Measure Information:
Title
Sensitivity 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer
Description
Proportion of patients demonstrating disease progression by conventional criteria evaluated by CT scan and 99mTc-methylene diphosphonate bone scan and on 18F-DCFPyL PET/CT.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Correlation of findings on 18F-DCFPyL PET/CT with conventional imaging as determined by Number of Lesions detected on each imaging modality
Description
Number of lesions detected on 18F-DCFPyL PET/CT in comparison to number of lesions detected on conventional imaging (99mTc-methylene diphosphonate bone scan and CT)
Time Frame
3 years

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological confirmation of prostate cancer Patients receiving androgen deprivation treatment (ADT) with GnRH analogs, GnRH antagonists or bilateral orchiectomy of any duration. Cohort A: nmCRPC (status post- primary treatment with radical prostatectomy, radiation of any type or both) Negative 99mTc-methylene diphosphonate bone scan and CT of the chest abdomen and pelvis within 6 weeks of 18F-DCFPyL PET/CT Treatment with ADT with or without a second line novel AR targeted treatment (abiraterone, enzalutamide, or both) or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted) for ≥ 12 months. Rising PSA ≥ 10 ng/ml (confirmed by 2 determinations one week apart) PSADT ≤ 9 months Cohort B: mCRPC Treatment with ADT with or without abiraterone and or enzalutamide or both for ≥ 6 months and/or 4 weeks after discontinuation of first generation antiandrogen (bicalutamide , flutamide, nilutamide- one or more permitted). PSA ≥ 2.0 ng/ml confirmed X 1 week apart, any PSADT Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility. No new therapeutic interventions planned or scheduled to be instituted prior to the course of this study both on cohorts A and B before conventional radiologic progression is evidenced. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures. Exclusion Criteria: Patient will be excluded from enrollment if he had a radioisotope within 5 physical half-lives prior to PET imaging
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Markowski
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer

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