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Prostate Cancer Patient Management With 18F-DCFPyL PET/CT

Primary Purpose

Prostate Cancer

Status
Enrolling by invitation
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
18F-DCFPyL PET/CT
Sponsored by
Sir Mortimer B. Davis - Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Male sex
  • Age 18 years or older
  • Previously diagnosed with prostate cancer, under referring physician's care
  • ECOG performance status 0 - 3, inclusive
  • Able to understand and provide written informed consent
  • Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection

Cohort A - High risk staging (HRS): Staging of high risk not previously treated patients as defined by any one of the following:

  • Gleason score > 7
  • Serum PSA > 15 ng/ml
  • T stage of T3 or greater on TNM staging
  • Equivocal/inconclusive conventional staging such as CT, MRI or bone scan
  • Clinical suspicion of advance stage disease (e.g. bone pain)

Cohort B - Biochemical recurrence: Restaging of biochemically recurrent prostate cancer patients as defined by increasing serum PSA on serial measurements and current PSA above 0.1 ng/ml following any treatment for prostate cancer.

Exclusion Criteria:

  • Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
  • Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
  • Patients with unmanageable claustrophobia

Sites / Locations

  • Jewish General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DCFPyL PET/CT

Arm Description

18F-DCFPyL PET/CT Scan

Outcomes

Primary Outcome Measures

Differences in optimal clinical management
Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.

Secondary Outcome Measures

Scan positivity fraction in BCR by PSA.
18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.
Adverse events
Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.

Full Information

First Posted
March 3, 2018
Last Updated
May 3, 2022
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03459820
Brief Title
Prostate Cancer Patient Management With 18F-DCFPyL PET/CT
Official Title
Differences in Optimal Prostate Cancer Patient Management as Proposed by a Panel of Experts Before and After 18F-DCFPyL PET/CT
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 22, 2018 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Mortimer B. Davis - Jewish General Hospital

4. Oversight

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

5. Study Description

Brief Summary
This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.
Detailed Description
Objectives: The primary objective of this study is to assess the differences in theoretical optimal clinical management afforded by 18F-DCFPyL PET/CT in prostate cancer patients as proposed by a central panel of experts. Primary endpoint: 1. Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts. Secondary endpoints: 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA. Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

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
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-DCFPyL PET/CT
Arm Type
Experimental
Arm Description
18F-DCFPyL PET/CT Scan
Intervention Type
Diagnostic Test
Intervention Name(s)
18F-DCFPyL PET/CT
Intervention Description
18F-DCFPyL Positron Emission Tomography/Computed Tomography Scan
Primary Outcome Measure Information:
Title
Differences in optimal clinical management
Description
Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Scan positivity fraction in BCR by PSA.
Description
18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.
Time Frame
30 days
Title
Adverse events
Description
Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.
Time Frame
2 hours

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only patients with prostate cancer are included.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male sex Age 18 years or older Previously diagnosed with prostate cancer, under referring physician's care ECOG performance status 0 - 3, inclusive Able to understand and provide written informed consent Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection Cohort A - High risk staging (HRS): Staging of high risk not previously treated patients as defined by any one of the following: Gleason score > 7 Serum PSA > 15 ng/ml T stage of T3 or greater on TNM staging Equivocal/inconclusive conventional staging such as CT, MRI or bone scan Clinical suspicion of advance stage disease (e.g. bone pain) Cohort B - Biochemical recurrence: Restaging of biochemically recurrent prostate cancer patients as defined by increasing serum PSA on serial measurements and current PSA above 0.1 ng/ml following any treatment for prostate cancer. Exclusion Criteria: Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter) Patients with unmanageable claustrophobia
Facility Information:
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Prostate Cancer Patient Management With 18F-DCFPyL PET/CT

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