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

Metastatic Prostate Cancer Clinical Trial

— PRAGMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04220983
• Other study ID #: 19-04020263
• Status: Completed
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: January 2024
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Number of Subjects With Adverse Events Will be Collected	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.	baseline, 3-6months and at 9-12 months.
Secondary	Change in Quality of Life Questionnaires Will be Assessed.	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.	baseline, 3-6months and at 9-12 months.
Secondary	Change in The International Prostate Symptom Score (I-PSS) Will be Assessed.	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.