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68Ga-PSMA PET/CT in Prostate Cancer

NCT ID: NCT03001869

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2023-07-01

Brief Summary

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The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and as a diagnostic and decision making tool in the management prostate cancer patients.The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a per-patient and per-lesion basis.

Detailed Description

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Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine diagnostic imaging procedure based on the measurement of positron emission from radiolabeled tracer molecules in vivo. A radiotracer in use today is 68Ga-HBED-CC-PSMA (DKFZ-11) - hereinafter abbreviated 68Ga-PSMA - which is a radiolabeled urea-based ligand for prostate specific membrane antigen (PSMA) PET/CT. Imaging with 68Ga-PSMA PET is used to characterize and localize prostate cancer in humans in vivo. There is extensive data in the literature showing the value of 68Ga-PSMA PET/CT imaging in accurately staging and restaging prostate cancer. The objectives of this study are to replicate the safety and efficacy of 68Ga-PSMA PET/CT and to establish our ability to reproduce results from the literature using 68Ga-PSMA PET/CT as a diagnostic and decision making tool in the management prostate cancer patients. During the study eligible prostate cancer patients will undergo one 68Ga-PSMA PET/CT. The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 7 days following the scan, and the sensitivity and specificity of 68Ga-PSMA PET/CT vs CT on a per-patient and per-lesion basis.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-PSMA PET/CT

68Ga-HBED-CC-PSMA PET/CT

Group Type EXPERIMENTAL

68Ga-HBED-CC-PSMA PET/CT

Intervention Type DRUG

68Ga-HBED-CC-PSMA PET/CT Scan

Interventions

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68Ga-HBED-CC-PSMA PET/CT

68Ga-HBED-CC-PSMA PET/CT Scan

Intervention Type DRUG

Other Intervention Names

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68Ga-PSMA-11

Eligibility Criteria

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Inclusion Criteria

* Resident of Canada
* 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

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

Clinical Indication Criteria Subgroups:

* BCR: Biochemical recurrence as defined by serum PSA \> 0.1 ng/ml following either radical prostatectomy or curative-intent radiotherapy or other prostate-ablative definitive management
* HRS: Staging of high risk patients as defined by any one of the following:

* Gleason score \> 7
* Serum PSA \> 10 ng/ml
* T stage of T3 or greater on TNM staging
* Equivocal conventional staging such as CT, MRI or bone scan
* Clinical suspicion of advance stage disease (e.g. bone pain)
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sir Mortimer B. Davis - Jewish General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stephan Probst, MD

Chief of Nuclear Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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16-293

Identifier Type: -

Identifier Source: org_study_id