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

Sir Mortimer B. Davis - Jewish General Hospital

Status and phase

Invitation-only

Phase 3

Phase 2

Conditions

Prostate Cancer

Treatments

Diagnostic Test: 18F-DCFPyL PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT03459820

18-002

Details and patient eligibility

About

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.

Full 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:

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.

Enrollment

1,500 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No 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