Prostate Cancer Clinical Trial
Official title:
An Open-label, Multi Center PET/CT Study for Investigation of Safety and Diagnostic Performance of the 68Ga Labeled PET Tracer [68Ga]RM2 in Patients With Primary Prostate Cancer
The aim of this study is to investigate safety and diagnostic performance of the 68Ga
labeled PET tracer [68Ga]RM2 for detection and localization of primary prostate cancer
confirmed by histopathology of the prostate as a standard of truth.
This is an open-label, multi center PET/CT (positron emission tomography/computed
tomography) non-randomized study. The study comprises 2 parts with an interim analysis after
Part 1. In Part 1 a total of 30 subjects with biopsy-proven primary prostate cancer will be
enrolled. Three strata of patients for the first part will be enrolled based on their
pretreatment recurrence risk assessment according to the NCCN guidelines: 10 patients with
low, 10 patients with intermediate and 10 patients with high pretreatment risk of
recurrence.
For inclusion, the prostate cancer needs to be histologically confirmed and MRI and PET/CT
with [18F]-choline (18F-choline is not mandatory) should be available for comparison.
Diagnostic [68Ga]RM2 will be injected intravenously into the subjects, and PET/CT imaging
performed. Images will be assessed visually and quantitatively. Subjects should be scheduled
for subsequent prostatectomy within 4 weeks after PET scan.
Prostate cancer will be confirmed by histopathological step-section analysis following
prostatectomy and used as Standard of Truth. Based on the results of the initial 30
patients, an expansion cohort of 50 patients for Part 2 will be enrolled to increase the
safety and tolerability database and to further characterize the uptake of [68Ga]RM2 in
specific subsets.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
| Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
| 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 | |
| Completed |
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 |