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
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Prostate Cancer||Radiation: MR-Guided Prostate SBRT||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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.
- 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.
- 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.
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
|Contact: Sharanya Chandrasekhar, M.S.||email@example.com|
|Contact: Pragya Yadav, Ph.D.||firstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10065|
|Contact: Sharanya Chandrasekhar, M.S. 646-962-2196 email@example.com|
|Contact: Pragya Yadav, Ph.D. 646-962-2199 firstname.lastname@example.org|
|Principal Investigator: Josephine Kang, M.D., Ph.D.|
|Principal Investigator:||Josephine Kang, M.D.,Ph.D.||Weill Cornell Medicine|