- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04220983
PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer (PRAGMA)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Weill Cornell Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
- For patients on systemic therapy, enrollment must be within six months of start of therapy unless exception is made by protocol PIs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: MR-Guided Prostate SBRT
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Number of Subjects With Adverse Events Will be Collected
Time Frame: baseline, 3-6months and at 9-12 months.
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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.
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baseline, 3-6months and at 9-12 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
There are 5 domains, urinary incontinence, urinary Irritative/Obstructive, Bowel, Sexual function and Hormonal.
For each domain, the 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.
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baseline, 3-6months and at 9-12 months.
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Change in The International Prostate Symptom Score (I-PSS) Will be Assessed.
Time Frame: baseline, 3-6months and at 9-12 months.
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The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicatingincreasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild (symptom score less than of equal to 7) Moderate (symptom score range 8-19) Severe (symptom score range 20-35) |
baseline, 3-6months and at 9-12 months.
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Collaborators and Investigators
Investigators
- Principal Investigator: Silvia Formenti, M.D., Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-04020263
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Vadim S KoshkinEli Lilly and Company; Prostate Cancer FoundationActive, not recruitingCastration-Resistant Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8 | Metastatic Castration-resistant Prostate Cancer | Metastatic Prostate Adenocarcinoma | Metastatic Castration-resistant Prostate CarcinomaUnited States
Clinical Trials on MR-Guided Prostate SBRT
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Fondazione del Piemonte per l'OncologiaUnknown
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Ardeshir RastinehadPhilips HealthcareRecruitingProstate Cancer | Prostate Disease | Elevated Prostate Specific Antigen | Family History of Prostate Cancer | Positive Digital Rectal ExamUnited States
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Heinrich-Heine University, DuesseldorfCompletedProstate CancerGermany
-
Profound Medical Inc.CompletedProstate CancerUnited States, Canada, Germany
-
InSightecUnknownLocalized Intermediate Risk Prostate LesionsUnited States
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Washington University School of MedicineTerminatedHepatocellular Carcinoma | Pancreatic Cancer | Pancreas Cancer | Cancer of the PancreasUnited States
-
Rush University Medical CenterActive, not recruiting
-
Jonsson Comprehensive Cancer CenterActive, not recruitingProstate AdenocarcinomaUnited States
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TC Erciyes UniversityCompleted