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PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer (PRAGMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04220983
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
Patients with metastatic prostate cancer can undergo MRI-guided prostate Stereotactic body radiation therapy (SBRT) without significant adverse events, similar to what has been reported for patients with localized prostate cancer. We hypothesize that prostate SBRT will be well-tolerated in metastatic prostate cancer patients, with quality of life outcomes similar to what has been reported in non-metastatic prostate cancer patients.

Condition or disease Intervention/treatment Phase
Metastatic Prostate Cancer Radiation: MR-Guided Prostate SBRT Phase 1

Detailed Description:

The MRidian ViewRay offers delivery of prostate SBRT with real-time MR guidance, which provides superior soft-tissue differentiation with excellent visualization of the prostate. This ViewRay platform offers the ideal setting for this study, that aims at precisely delivering prostate SBRT with a simultaneous integrated boost (when indicated) to visible nodules.

In this study, we hope to demonstrate the safety and feasibility of using 36.25 Gy in 5 fractions, plus a simultaneous integrated boost (when indicated), in patients with metastatic prostate cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer
Actual Study Start Date : December 4, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
MR-Guided Prostate SBRT Radiation: MR-Guided Prostate SBRT
Prostate SBRT has become a standard of care for the treatment of localized prostate cancer. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity when planning is delivered appropriately.




Primary Outcome Measures :
  1. Change in Number of Subjects with Adverse events will be collected [ Time Frame: baseline, 3-6months and at 9-12 months. ]
    Treatment will be deemed safe if there is no more than 3 acute Grade 3 gasterointestinal/genitourinary events within the first 30 days after treatment completion. Adverse events can be unexpected or expected, related to treatment.


Secondary Outcome Measures :
  1. Change in Quality of life questionnaires will be assessed. [ Time Frame: baseline, 3-6months and at 9-12 months. ]
    Expanded Prostate Cancer Index Composite (EPIC) short form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes. QOL assessments will occur at baseline, 3-6 months, and at 9-12 months.

  2. Change in The American Urological Association (AUA) symptom score will be assessed. [ Time Frame: baseline, 3-6months and at 9-12 months. ]
    The American Urological Association (AUA) has created this symptom index for understanding the severity of enlarged prostate symptoms. Scores ranging from 0-7 are considered to be mild symptoms, 8-19 are moderate and 20 - 35 are severe symptoms.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy-proven diagnosis of prostate adenocarcinoma
  • Age ≥ 18
  • Must have biopsy-proven metastatic prostate cancer

Exclusion Criteria:

  • History of prior pelvic radiation (external beam or brachytherapy)
  • Inability to undergo MRI
  • AUA score >20
  • Evidence of disease progression on bone scan, MR and/or CT
  • For patients on systemic therapy, enrollment must be within six months of start of therapy unless exception is made by protocol PIs.

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): NCT04220983


Contacts
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Contact: Sharanya Chandrasekhar, M.S. 646-962-2196 shc2043@med.cornell.edu
Contact: Pragya Yadav, Ph.D. 646-962-2199 pry2003@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Sharanya Chandrasekhar, M.S.    646-962-2196    shc2043@med.cornell.edu   
Contact: Pragya Yadav, Ph.D.    646-962-2199    pry2003@med.cornell.edu   
Principal Investigator: Josephine Kang, M.D., Ph.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Josephine Kang, M.D.,Ph.D. Weill Cornell Medicine

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04220983    
Other Study ID Numbers: 19-04020263
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases