N/A
N=64
High Resolution MRI Study for Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03292874 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Sensitivity and Specificity of High Resolution Versus Standard MRI in Identifying Adverse Histology — 75; 71; 84; 54.8 percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- high resolution MRI (hrMRI) (Diagnostic_test)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Male
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of High Resolution Versus Standard MRI in Identifying Adverse Histology |
75; 71; 84; 54.8 | — |
| PRIMARY Area Under the Receiver Operator Curve of High Resolution Versus Standard MRI in Identifying Adverse Histology |
0.794; 0.631 | 0.014 sig |
Summary
This high resolution MRI (hrMRI), along with stand MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance. Changes in lesion size and ADC values will be assessed on the serial studies. This study evaluates the hypothesis that hrMRI will detect changes that sMRI cannot detect and that these changes will correlate with prostate cancer progression as determined on prostate biopsy.
Eligibility Criteria
Inclusion Criteria
- Age over 18 years
- Patients diagnosed with clinically localized prostate cancer
- Low or Low-intermediate Risk Prostate cancer1 defined as:
- Pre-operative prostate specific antigen (PSA) ≤ 20.0 ng/ml
- Clinical stage cT1 or cT2
- Gleason score 3+3 or 3+4
- Patients choosing AS or already on AS as primary management strategy
- No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy
- No contraindications for gadolinium enhanced MRI
Exclusion Criteria
- No exclusion criteria
Data sourced from ClinicalTrials.gov (NCT03292874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.