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Phase I Study MR-guided SBRT to PCa (MRgRTPCa)

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ClinicalTrials.gov Identifier: NCT03935308
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Ning Wen, Ph.D., Henry Ford Health System

Brief Summary:
1) investigate the feasibility, tolerance, and safety of dose escalation via MR-guided stereotactic body radiation therapy and simultaneous integrated boost to the dominant intraprostatic lesions (DILs), 2) to assess the feasibility of DIL visualization based on multi-parametric MRI (mpMRI), and 3) to characterize longitudinal changes in imaging characteristics and identify urinary biomarkers for treatment response prediction

Condition or disease Intervention/treatment Phase
Low or Intermediate Risk Prostate Cancer Radiation: MR guided Linear Accelerator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study Of MR-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost (SIB) To the Dominant Intraprostatic Lesion(s) (DILs) in Men With Localized Prostate Cancer
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: MR-guided SBRT With SIB to the DILs to Prostate Cancer
Dose escalation to the DIL(s) will be performed in the traditional Phase I 3+3 design. Patients will be treated in four cohorts (three patients per dose level) starting with a dose of 9 Gy to the DIL(s). If no dose limiting toxicity (DLT), defined below, is observed after 90 days, then an additional three patients will be entered at the next dose level. Dose to the DIL(s) will be escalated at 1 Gy increments until DLT is observed or if maximum dose level (60 Gy in 5 fractions of 12 Gy) is reached with no observed DLT. If one of the three patients experience a DLT at a particular dose level an additional three patients will be enrolled at that level. If two or more patients experience a DLT a lower dose level will be explored to define the maximum tolerated dose (MTD). The three patients within any cohort can be enrolled simultaneously or sequentially without any waiting period among them.
Radiation: MR guided Linear Accelerator
The aim is to perform treatment planning to compute the highest feasible simultaneous boosting dose to the intraprostatic lesion while respecting normal tissue dose constraints. Patients will be treated with MR-guided localization and adaptive planning techniques.




Primary Outcome Measures :
  1. Determine the maximum tolerated dose to DILs until dose limiting toxicity (>=3 grade 3 GI/GU toxicity) is observed or if maximum dose level is reached [ Time Frame: 2 years ]
    The study aims to evaluate the safety and feasibility to employ a simultaneous integrated boost to MRI detected dominant intraprostatic lesion(s) during SBRT


Secondary Outcome Measures :
  1. Quality of Life measures using the Epic questionnaire [ Time Frame: 2 years ]
    Dose and volume data will be collected and correlated with treatment-related side effects and quality of life data.



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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:

  • Histologically confirmed prostate adenocarcinoma.
  • Patients with low or favorable intermediate risk prostate cancer and patients with unfavorable intermediate risk prostate cancer who decline androgen deprivation therapy
  • Pretreatment evaluations must be completed as specified in Section 4.0
  • Patients must sign a study-specific informed consent form prior to study participation.
  • No contraindication to MRI. For example, patients with metal fragments or implanted devices such as pacemakers and aneurysm clips may not be eligible for the study
  • At least one intraprostatic lesion can be identified on the mpMR images.
  • Patients agree to have hydrogel placed.

Exclusion Criteria:

  • Patients who have a contraindication to contrast-enhanced MRI are not eligible. Patients with an implanted device such as a pacemaker or metal fragments are not eligible.

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): NCT03935308


Locations
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United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Ning Wen, PhD    313-916-1162    nwen1@hfhs.org   
Contact: Taylor Christensen    313-916-3935    TChrist6@hfhs.org   
Sponsors and Collaborators
Henry Ford Health System
American Cancer Society, Inc.

Publications:

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Responsible Party: Ning Wen, Ph.D., Director, Clinical Physics, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03935308     History of Changes
Other Study ID Numbers: MRgSBRT
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Ning Wen, Ph.D., Henry Ford Health System:
prostate cancer, MRI, intraprostatic lesions

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases