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.
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
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
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
dynamic contrast-enhanced MRI (DCE)
DeviceBiopsy
ProcedurePrimary outcomes
-
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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