- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02312401
Evaluation of Treatment Response Using Multiparametric MRI After Prostate Radiotherapy
October 2, 2023 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to better understand prostate cancer changes after radiation treatment, through magnetic resonance imaging (MRI).
MRI is an imaging test that allows doctors to see prostate gland without any operation procedures.
It can help identifying the tumors in the prostate.
For patients with newly diagnosed prostate cancer, MRI may help doctors manage treatment better and sooner.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
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Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Rockville Centre, New York, United States
- Memorial Sloan Kettering Rockville Centre
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Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with biopsy proven (completed and/or reviewed at MSK) adenocarcinoma of the prostate, who will undergo external beam radiotherapy using conventional fractionation IGRT including moderate hypofractionated radiation, low rate brachytherapy alone, brachytherapy (either high dose or low dose) combined with supplemental image guided radiation (including IGRT, EBRT, and SBRT), SBRT, or proton radiotherapy.
- Age ≥ 18 years old
- Baseline MP-MRI, which is obtained at MSKCC Main Campus on the 3-Tesla Philips MRI unit as part of the standard (clinical) staging assessment demonstrates at least one dominant or visible lesion which measures > 0.5 cm in maximum axial diameter as assessed on T2-weighted images.
- No prior history of androgen deprivation therapy within the last month. However patients who will receive neoadjuvant and concurrent and adjuvant hormonal therapy will be eligible.
- Willing to come to MSK Main Campus for baseline and follow-up MP-MRIs.
Exclusion Criteria:
- History of radical prostatectomy
- Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.
- Patients with a metallic hip implant, metallic implant or device in the pelvis or ferromagnetic fiducial beacons (Calypso) that might distort local magnetic field and compromise quality of MP-MRI
- Patients in which gadolinium contrast is contra-indicated.
- Metastatic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multiparametric MRI
Patients undergo baseline standard (clinical) MP-MRI prior to therapy (ADT or RT).
After completion of radiotherapy, follow-up MRIs will be obtained using the same 3T Philips MRI unit at approximately 3, 6, 12, 18 & 24 (+/- 4 weeks) months after radiotherapy.
A standard post-tx biopsy will be performed at 24 months (+/- 4 weeks) after therapy which will serve to define the local control status after therapy.
Local control based on this biopsy will be interpreted as negative or adenoca with severe tx effect; a positive biopsy will be a specimen which demonstrates adenocarcinoma that can be classified with a Gleason score as we have previously reported.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
characterize the changes in tumor characteristics by functional imaging changes with post-treatment prostate biopsy outcomes
Time Frame: at 24 months after completion of radiotherapy
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This change will then be correlated with the biopsy outcome (binary) by two sample t-tests.
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at 24 months after completion of radiotherapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Neelam Tyagi, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2014
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
December 5, 2014
First Submitted That Met QC Criteria
December 5, 2014
First Posted (Estimated)
December 9, 2014
Study Record Updates
Last Update Posted (Actual)
October 3, 2023
Last Update Submitted That Met QC Criteria
October 2, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-172
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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