Prostate Cancer Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |