Clinical Trials Logo
NCT number NCT02840552
Study type Interventional
Source Sir Mortimer B. Davis - Jewish General Hospital
Contact
Status Enrolling by invitation
Phase Phase 3
Start date September 2016
Completion date December 2020

Clinical Trial Summary

The objectives of this study are to confirm the safety and efficacy of FCH-PET/CT and to establish our ability to reproduce results from the literature using FCH-PET/CT as a diagnostic and decision making tool in the management in two predefined groups of prostate cancer patients, specifically, biochemical recurrence and high risk staging. The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 24 hours following the scan, and the sensitivity and specificity of FCH-PET/CT vs CT on a per-patient and per-lesion basis.


Clinical Trial Description

Background Prostate cancer is the second leading cause of cancer death in North American men older than 50 years. Positron emission tomography / computer tomography (PET/CT) is a nuclear medicine procedure based on the measurement of positron emission from radiolabeled tracer molecules. A common radiotracer in use today is 18F-fluoromethylcholine (aka fluorocholine or FCH) which is a radiolabeled choline derivative. Imaging with FCH-PET/CT can be used to characterize and localize prostate cancer in vivo. There is extensive data in the literature showing the value of FCH-PET/CT imaging in accurately staging and restaging prostate cancer. FCH-PET/CT is standard of care in many European countries.

Study Objectives The objectives of this study are to confirm the safety and efficacy of FCH-PET/CT and to establish our ability to reproduce results from the literature using FCH-PET/CT as a diagnostic and decision making tool in the management in two predefined groups of prostate cancer patients, specifically, biochemical recurrence and high risk staging. The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 24 hours following the scan, and the sensitivity and specificity of FCH-PET/CT vs CT on a per-patient and per-lesion basis.

Study Design This will be a multi-center open label study in which one (1) FCH-PET/CT will be performed on study participants. A PET/CT scan takes 2-3 hours.

Safety FCH-PET/CT exhibits favorable dosimetry, delivering organ doses that are comparable to or lower than those delivered by 18F-FDG. The safety of FCH is not disputed and we expect the number of adverse events in our study to be zero.

Sample Size and Recruitment Target enrollment is 1500 patients. This will be sufficient to detect AE with a prevalence of 0.3% with 99% confidence. For efficacy endpoints, approximately 500 subjects would provide 90% power at the alpha=0.05 one-sided level of significance that the specificity and sensitivity will be superior to the specificity and sensitivity under the null hypothesis. Patients will be recruited by urologists in the clinical setting. Initial contact and consent will be by the department of urology.


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT03177759 - Living With Prostate Cancer (LPC) N/A
Recruiting NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data N/A
Recruiting NCT02945813 - SAKK 08/15 - PROMET - Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy Phase 2
Recruiting NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A
Completed NCT02124668 - A Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy Phase 2
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Active, not recruiting NCT00779168 - White Button Mushroom Extract in Treating Patients With Recurrent Prostate Cancer After Local Therapy Phase 1
Recruiting NCT02799706 - Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer Phase 3
Recruiting NCT01990196 - Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer Phase 2
Recruiting NCT02766543 - Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer Phase 2
Recruiting NCT03134027 - Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers N/A
Not yet recruiting NCT03284684 - Kinetics of Perioperative Circulating DNA in Cancer Surgery N/A
Not yet recruiting NCT03256630 - Evaluation of Urine and Blood Biomarkers to Try and Distinguish Between the Presence or Absence of Aggressive Prostate Cancer N/A
Not yet recruiting NCT03263780 - High Resolution PET-MRI Before Prostate Cancer HIFU Early Phase 1
Recruiting NCT02911922 - Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer N/A
Recruiting NCT02918357 - Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence Phase 2/Phase 3
Recruiting NCT02916537 - A Phase 1 Trial for Safety and Imaging Evaluation of CTT1057, a Small Molecule Inhibitor of Prostate Specific Membrane Antigen (PSMA) Phase 1
Recruiting NCT02543255 - Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC Trial) Phase 2