Evaluation of Treatment Response Using Multiparametric MRI After Prostate Radiotherapy

NCT02312401 | Active Not Recruiting Phase 2

• 1 other identifier: 14-172
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 8

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.

Conditions

Prostate Cancer

Keywords

MRI; 14-172

Outcome Measures

Primary Outcomes (1)

• characterize the changes in tumor characteristics by functional imaging changes with post-treatment prostate biopsy outcomes

  This change will then be correlated with the biopsy outcome (binary) by two sample t-tests.

  at 24 months after completion of radiotherapy

Study Arms (1)

Multiparametric MRI

EXPERIMENTAL

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

Interventions

multi-parametric MRI(MP-MRI) DEVICE

Multiparametric MRI

dynamic contrast-enhanced MRI (DCE) DEVICE

Multiparametric MRI

biopsy PROCEDURE

Multiparametric MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (8)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dynamic Contrast Enhanced Magnetic Resonance Imaging; Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Neelam Tyagi, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: December 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (8)