Evaluation of Treatment Response Using Multiparametric MRI After Prostate Radiotherapy

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02312401
• Collaborator: (none)
• Enrollment: 120
• Locations: 8
• Arm: 1
• Anticipated Duration (Months): 108
• Patients Per Site: 15
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 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: Dec 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. characterize the changes in tumor characteristics by functional imaging changes with post-treatment prostate biopsy outcomes [at 24 months after completion of radiotherapy]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memoral Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	Memorial Sloan Kettering Rockville Centre	Rockville Centre	New York	United States
8	Memorial Sloan Kettering Nassau	Uniondale	New York	United States	11553

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Michael Zelefsky, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT02312401
• Other Study ID Numbers: 14-172
• First Posted: Dec 9, 2014
• Last Update Posted: Aug 15, 2022
• Last Verified: Aug 1, 2022

• Keywords provided by Memorial Sloan Kettering Cancer Center: MRI; 14-172
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Aug 15, 2022