Status:
COMPLETED
A Phase II, Prospective Study of MRI in the Reclassification of Men Considering Active Surveillance in Prostate Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- Age ≥18
- Life expectancy of greater than 10 years
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2023
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01858688
Start Date
September 1 2013
End Date
April 1 2023
Last Update
May 3 2023
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215