NCT04220983: PRAGMA

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

Completed NA Results posted Last updated 6 February 2024

What this trial tests

NA trial testing MR-Guided Prostate SBRT in Metastatic Prostate Cancer in 22 participants. Completed in 28 February 2023.

Timeline

27 January 2020

Primary endpoint
28 February 2023

28 February 2023

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	27 January 2020
Primary completion	28 February 2023
Estimated completion	28 February 2023
Sites	1 location across United States

Drugs / interventions tested

• MR-Guided Prostate SBRT

Conditions studied

• Metastatic Prostate Cancer — all drugs for Metastatic Prostate Cancer →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 18 to 90, male only, with Metastatic Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Number of Subjects With Adverse Events Will be Collected Primary · 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.

Baseline

Group	Value	95% CI
MR-Guided Prostate SBRT	22

3-6 months

Group	Value	95% CI
MR-Guided Prostate SBRT	18

9-12 months

Group	Value	95% CI
MR-Guided Prostate SBRT	17

Change in Quality of Life Questionnaires Will be Assessed. Secondary · 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.

Baseline : Urinary incontinence

Group	Value	95% CI
MR-Guided Prostate SBRT	80.6	± 22.1

Baseline : Urinary Irritative/Obstructive

Group	Value	95% CI
MR-Guided Prostate SBRT	83.4	± 15.5

Baseline : Bowel

Group	Value	95% CI
MR-Guided Prostate SBRT	96.8	± 5.5

Baseline : Sexual Function

Group	Value	95% CI
MR-Guided Prostate SBRT	8.6	± 14.1

Baseline : Hormonal

Group	Value	95% CI
MR-Guided Prostate SBRT	74.1	± 19.3

3-6 months : Urinary incontinence

Group	Value	95% CI
MR-Guided Prostate SBRT	84.75	± 2.93

3-6 months : Urinary Irritative/Obstructive

Group	Value	95% CI
MR-Guided Prostate SBRT	84.55	± 0.47

3-6 months : Bowel

Group	Value	95% CI
MR-Guided Prostate SBRT	92.2	± 3.2

Change in The International Prostate Symptom Score (I-PSS) Will be Assessed. Secondary · baseline, 3-6months and at 9-12 months.

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

Group	Value	95% CI
MR-Guided Prostate SBRT	10.7	± 7.9

3-6 months

Group	Value	95% CI
MR-Guided Prostate SBRT	9	± 1.2

9-12 months

Group	Value	95% CI
MR-Guided Prostate SBRT	12.2	± 1.12

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline, 3-6 months, 9-12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MR-Guided Prostate SBRT

Serious: 1/22 (5%)

Deaths: 2/22

Serious adverse events (1 terms)

Reaction	System	MR-Guided Prostate SBRT
Diffused Pruritic Rash	Skin and subcutaneous tissue disorders	—

Other adverse events (11 terms — click to expand)

Reaction	System	MR-Guided Prostate SBRT
Urinary Frequency	Renal and urinary disorders	—
Fatigue	General disorders	—
Hot flashes	Vascular disorders	—
Bladder incontinence	Renal and urinary disorders	—
Constipation	Gastrointestinal disorders	—
Lower back pain	Musculoskeletal and connective tissue disorders	—
Weak Urine Stream	Renal and urinary disorders	—
Nocturia	Renal and urinary disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Appetite change	Gastrointestinal disorders	—
Anxiety	Nervous system disorders	—

Most-reported serious reactions: Diffused Pruritic Rash.

Data from ClinicalTrials.gov NCT04220983 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.