Prostate Cancer Clinical Trial
Official title:
A Randomized Two-Arm Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management: The MGM Trial
1. Using multiparametric MRI Ultrasound-guided or MRI-guided biopsies will allow more
accurate sampling of the tumors and therefore will increase the rate of "progression"
on early (first and second) surveillance biopsies and decrease the rate of
"progression" on late (third and further) surveillance biopsies compared to Transrectal
Ultrasound-guided biopsies.
2. Quality of life (QoL) will be similar in patients undergoing MRI Ultrasound or
MRI-guided and Transrectal Ultrasound-guided biopsies.
3. Biomarker expression levels will correlate with biopsy progression.
Favorable risk patients will be randomized to one of two active surveillance arms.
Stratification will be based on Prostate-specific antigen density (PSAD) (=< 0.15 vs > 0.15
ng/mL per mL), and number of positive cores in the diagnostic biopsy (1 vs 2):
- Arm I: Active Surveillance Alone (AS). TRUS guided biopsies at start (within 6 months
of enrollment) and at yearly intervals thereafter up to 36 months after the initial
biopsy (maximum four biopsies).
- Arm II: MRI-Managed Active Surveillance (MRI-AS). MRIus or MRI-guided biopsies at start
(within 6 months of enrollment) and at yearly intervals thereafter up to 36 months
after the initial biopsy (maximum four biopsies).
Patients will also complete Quality of Life (QoL) assessments to provide unique data on the
effects of MRI monitoring for patients undergoing active surveillance on QOL. The
investigators have selected a group of measures that have been used extensively in prostate
cancer populations.
;
Observational Model: Cohort, Time Perspective: Prospective
| 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 |
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 |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| 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 |