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Active, Not Recruiting

NCT Number: NCT02312401

Evaluation of Treatment Response Using Multiparametric MRI After Prostate Radiotherapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multi-parametric MRI(MP-MRI)

Device

dynamic contrast-enhanced MRI (DCE)

Device

Biopsy

Procedure

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2014
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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