A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 101
- Locations
- 4
- Primary Endpoint
- MP-erMRI Classification Sensitivity
Study Overview
Brief 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.
Detailed Description
Before the research starts (screening): After signing this consent form, you will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated.
- A medical history, which includes questions about your health, current medications, any allergies and evaluation for whether you can safely have an MRI and biopsy
- Performance status, which evaluates how you are able to carry on with your usual activities.
- Review of the initial diagnostic biopsy, which you had when you were diagnosed with prostate cancer.
- Routine Blood Tests ( PSA is a protein that is produced by the prostate gland. The PSA test has been widely used to screen men for prostate cancer. It is also used to monitor men who have been diagnosed with prostate cancer to see if their cancer is responding to therapy)
- Physical Exam
- Health State Questionnaires
- These questionnaires review: Your feelings about your cancer diagnosis, your satisfaction with the cancer care you received, your health and symptoms over the past four weeks, and your overall urinary function
If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
After the screening procedures confirm that you are eligible to participate in the research study:
- You will be scheduled for a MRI between 2 to 14 months after your initial biopsy, which showed prostate cancer, to assess the grade and extent of your prostate cancer since your initial diagnosis.
- You will be scheduled for a repeat prostate biopsy 0-3 months after your MRI is reviewed.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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: <10 ng/mL
- •Clinical stage: ≤T2a & N0 or NX & M0
- •The subject is able and willing to abide by the study protocol or cooperate fully with the investigator or designee
- •The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document
- •Life expectancy of greater than 10 years
- •Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
- •Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- •First diagnosis of prostate cancer > 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
Outcomes
Primary Outcomes
MP-erMRI Classification Sensitivity
Time Frame: From baseline biopsy to final biopsy, up to 18 months
The classification sensitivity of multiparametric endorectal magnetic resonance imaging (MP-erMRI) when compared to the standard of care procedure (transrectal ultrasound-guided (TRUS) re-biopsy) The sensitivity is equivalent to the proportion of patients who were reclassified by MP- erMRI out of the total number of patients who should have been reclassified (given their TRUS re-biopsy result). In other words, it is the proportion of participants reclassified appropriately by MP- erMRI.
MP- erMRI Classification Specificity
Time Frame: From baseline biopsy to final biopsy, up to 18 months
The classification specificity of multiparametric endorectal magnetic resonance imaging (MP-erMRI) when compared to the standard of care procedure (transrectal ultrasound-guided (TRUS) re-biopsy) The specificity is equivalent to the proportion of patients who were not reclassified by MP- erMRI out of the total number of patients who should have been not reclassified (given their TRUS re-biopsy result). In other words, it is the proportion of participants not reclassified appropriately by MP- erMRI.
Secondary Outcomes
- Frequency of Reclassification(From baseline biopsy to final MRI, up to 18 months)
- Median Change in Illness-Related Uncertainty, Anxiety, and Distress(From baseline biopsy to final MRI, up to 18 months)
- Median Change in Service Satisfaction(From baseline biopsy to final MRI, up to 18 months)
- Gleason Score by Classification Status(From baseline biopsy to final biopsy, up to 18 months)
- Median Change in Prostate Cancer Symptoms(From baseline biopsy to final MRI, up to 18 months)
- Median Change in Urinary Symptoms(From baseline biopsy to final MRI, up to 18 months)
- Disease Extent by Classification Status(From baseline biopsy to final biopsy, up to 18 months)
Investigators
Neil Martin, MD
Principal Investigator
Dana-Farber Cancer Institute