Clinical trial NCT03459820: 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
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 1500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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:

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.

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

Primary outcomes:
measure: Differences in optimal clinical management
timeFrame: 30 days
Secondary outcomes:
measure: Scan positivity fraction in BCR by PSA.
timeFrame: 30 days
measure: Adverse events
timeFrame: 2 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References: