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

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ClinicalTrials.gov Identifier: NCT03459820
Recruitment Status : Enrolling by invitation
First Posted : March 9, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Stephan Probst, Sir Mortimer B. Davis - Jewish General Hospital

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: 18F-DCFPyL PET/CT Phase 3

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:

  1. 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.
  2. Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Differences in Optimal Prostate Cancer Patient Management as Proposed by a Panel of Experts Before and After 18F-DCFPyL PET/CT
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-DCFPyL PET/CT
18F-DCFPyL PET/CT Scan
Diagnostic Test: 18F-DCFPyL PET/CT
18F-DCFPyL Positron Emission Tomography/Computed Tomography Scan




Primary Outcome Measures :
  1. Differences in optimal clinical management [ Time Frame: 30 days ]
    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 :
  1. Scan positivity fraction in BCR by PSA. [ Time Frame: 30 days ]
    18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.

  2. Adverse events [ Time Frame: 2 hours ]
    Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only patients with prostate cancer are included.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459820


Locations
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Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital

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Responsible Party: Stephan Probst, Chief of Nuclear Medicine, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT03459820     History of Changes
Other Study ID Numbers: 18-002
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases