Prostate Cancer
Conditions
Keywords
stage I prostate cancer, stage IIA prostate cancer, stage IIB prostate cancer
Brief summary
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help find prostate cancer and learn the extent of disease. PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in diagnosing prostate cancer.
Detailed description
OBJECTIVES: * To determine the ability of multiparametric magnetic resonance imaging (MP-MRI) to identify men who can safely avoid unnecessary biopsy. * To assess the ability of the MP-MRI-based diagnostic pathway to improve the rate of detection of clinically significant cancer as compared to transrectal ultrasound (TRUS) biopsy. * To estimate the cost-effectiveness of an MP-MRI based diagnostic pathway. OUTLINE: This is a multicenter study. Patients undergo multiparametric magnetic resonance imaging (MRI) (T2-weighted imaging, diffusion-weighted MRI, and dynamic contrast-enhanced MRI) followed by template prostate mapping and transrectal ultrasound biopsy. Some patients may undergo blood, urine, and tissue sample collection periodically for biomarker studies. Samples are banked for future research analysis. Patients complete a quality-of-life questionnaire (EQ-5D) at baseline, during, and after completion of study. An economic analysis will be performed for cost-effectiveness. After completion of study intervention, patients are followed up periodically.
Interventions
OTHERbiologic sample preservation procedure
OTHERlaboratory biomarker analysis
OTHERstudy of socioeconomic and demographic variables
PROCEDUREdiffusion-weighted magnetic resonance imaging
PROCEDUREdynamic contrast-enhanced magnetic resonance imaging
PROCEDUREquality-of-life assessment
PROCEDUREtransperineal prostate biopsy
PROCEDUREtransrectal prostate biopsy
PROCEDUREultrasound-guided prostate biopsy
Sponsors
University College London Hospitals
Study design
Primary purpose
DIAGNOSTIC
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Men at risk of prostate cancer who have been advised to have a prostate biopsy * Suspected stage ≤ T2 on rectal examination (organ confined) * Serum PSA ≤ 15 ng/mL within the past 3 months PATIENT CHARACTERISTICS: * Fit for general/spinal anesthesia * Fit to undergo all protocol procedures including a transrectal ultrasound * No evidence of a urinary tract infection or history of acute prostatitis within the past 3 months * No contraindication to MRI (e.g., claustrophobia, pacemaker, or estimated GFR ≤ 50) * No other medical condition precluding procedures described in the protocol PRIOR CONCURRENT THERAPY: * No prior prostate biopsy, prostate surgery, or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction are acceptable) * No prior hip replacement surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of multiparametric magnetic resonance imaging (MP-MRI) | — |
| Recruitment | — |
| Proportion of men who could safely avoid biopsy as determined by specificity and negative predictive values | — |
| Proportion of men correctly identified by MP-MRI to have clinically significant prostate cancer as determined by sensitivity and positive predictive values | — |
Secondary
| Measure | Time frame |
|---|---|
| Intra-observer variability in the reporting of MP-MRI | — |
| Evaluation of socio-demographic, clinical, imaging and radiological variables in relation to the detection of clinically significant prostate cancer | — |
| Proportion of men who could safely avoid biopsy | — |
| Resource use and costs for further economic evaluation | — |
| Translational research | — |
| Health-related quality of life using the EQ-5D questionnaire | — |
| Proportion of men testing positive on MP-MRI | — |
| Performance characteristics of TRUS versus template prostate mapping (TPM) | — |
| Evaluation of the optimal combination of MP-MRI functional parameters | — |
Outcome results
None listed