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

Launched by SIR MORTIMER B. DAVIS - JEWISH GENERAL HOSPITAL · Mar 8, 2018

Keywords

ClinConnect Summary

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 p...

Gender

MALE

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