N/A
N=101
A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01858688 ↗Enrolled (actual)
101
Serious AEs
2.1%
Results posted
May 2022
Primary outcome: Primary: MP-erMRI Classification Sensitivity — 0.875 proportion of true positives
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multiparametric MRI (Device); Prostate biopsy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MP-erMRI Classification Sensitivity |
0.875 | — |
| PRIMARY MP- erMRI Classification Specificity |
0.785 | — |
| SECONDARY Frequency of Reclassification |
40 | — |
| SECONDARY Median Change in Illness-Related Uncertainty, Anxiety, and Distress |
-2 | — |
| SECONDARY Median Change in Service Satisfaction |
— | — |
| SECONDARY Median Change in Prostate Cancer Symptoms |
— | — |
| SECONDARY Median Change in Urinary Symptoms |
0; 0 | — |
| SECONDARY Disease Extent by Classification Status |
— | — |
| SECONDARY Gleason Score by Classification Status |
— | — |
Summary
Some men newly diagnosed with prostate cancer do not require immediate treatment. Rather, they can be followed closely with regular physical exams, blood work and repeated biopsies of the prostate. If the prostate cancer is becoming more aggressive, curative treatment can be offered at that time. This strategy of delaying treatment until necessary is called active surveillance in prostate cancer.
Active surveillance is a way of monitoring prostate cancer which aims to avoid or delay unnecessary treatment in men with less aggressive cancer.
Prostate cancer can be slow growing and, for many men, the disease may never progress or cause any symptoms. In other words, many men with prostate cancer will never need any treatment. Treatments for prostate cancer may cause side effects which can affect your quality of life. By monitoring the cancer with regular tests, you can avoid or delay these side effects.
Active surveillance is generally suitable for men with low risk early stage prostate cancer that is contained within the prostate gland (localized prostate cancer).
If doctors had a better way of identifying who might be best suited for this approach, it would likely become more appealing for more men. In this study, the investigators are looking at how accurate a magnetic resonance imaging (MRI) scan is at identifying high-risk prostate cancer, which might make a man a poor candidate for active surveillance.
To do this, the investigators are collecting data from the MRI scan of men and comparing it to a trans-rectal biopsy performed following the scan. The results of this study will help inform doctors how accurate the MRI is in identifying men who should not be on active surveillance.
Eligibility Criteria
Inclusion Criteria
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- The subject will have histologically confirmed prostate cancer with all of the following features:
- Minimum 10 core prostate biopsy showing histologically-confirmed prostate cancer within 12 months of enrollment reviewed by a pathologist from one of the DF/HCC associated hospitals
- Gleason ≤3+3
- No tertiary Gleason grade ≥4
- ≤3 total cores positive
- ≤50% of any given core involved with cancer
- No evidence on biopsy of extracapsular extension
- PSA within one month of enrollment: 12 months prior to enrollment
- Prior prostate cancer-directed therapy including:
- androgen deprivation therapy
- radiation therapy to the prostate (external beam or brachytherapy)
- cryotherapy
- high-intensity focused ultrasound (HIFU)
- chemotherapy for prostate cancer
- Prior transurethral resection of prostate
- Subject who is deemed by the treating physician to have a contraindication to definitive treatment
- Subjects with a contraindication to an MRI including those with a pacemaker, ferromagnetic aneurysm clip, or cochlear implants
- Subjects with a contraindication to receiving Gadolinium containing contrast for the MRI
- Conditions which make repeat TRUS biopsies not feasible
Data sourced from ClinicalTrials.gov (NCT01858688). 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.