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Evaluation of Treatment Response Using Multiparametric MRI After Prostate Radiotherapy

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ClinicalTrials.gov Identifier: NCT02312401
Recruitment Status : Recruiting
First Posted : December 9, 2014
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: multi-parametric MRI(MP-MRI) Device: dynamic contrast-enhanced MRI (DCE) Procedure: biopsy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Treatment Response Using Multiparametric MRI After Prostate Radiotherapy
Actual Study Start Date : December 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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.
Device: multi-parametric MRI(MP-MRI)
Device: dynamic contrast-enhanced MRI (DCE)
Procedure: biopsy



Primary Outcome Measures :
  1. 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 ]
    This change will then be correlated with the biopsy outcome (binary) by two sample t-tests.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02312401


Contacts
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Contact: Michael Zelefsky, MD 212-639-6802
Contact: Hebert A. Vargas, MD 212-639-4017

Locations
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United States, New Jersey
Memorial Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Michael Zelefsky, MD    212-639-6802      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Michael Zelefsky, MD    212-639-6802      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Michael Zelefsky, MD    212-639-6802      
Principal Investigator: Michael Zelefsky, MD         
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States
Contact: Michael Zelefsky, MD    212-639-6802      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Michael Zelefsky, MD    212-639-6802      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Michael Zelefsky, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02312401    
Other Study ID Numbers: 14-172
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
MRI
14-172
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases