Trial Outcomes & Findings for PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer (NCT NCT04220983)
NCT ID: NCT04220983
Last Updated: 2024-02-06
Results Overview
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.
COMPLETED
NA
22 participants
baseline, 3-6months and at 9-12 months.
2024-02-06
Participant Flow
Participant milestones
| Measure |
MR-Guided Prostate SBRT
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.
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|---|---|
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Overall Study
STARTED
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22
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Overall Study
COMPLETED
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22
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
MR-Guided Prostate SBRT
n=22 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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6 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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16 Participants
n=5 Participants
|
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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22 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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21 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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16 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
MR-Guided Prostate SBRT
n=22 Participants
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.
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|---|---|
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Change in Number of Subjects With Adverse Events Will be Collected
Baseline
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22 Participants
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Change in Number of Subjects With Adverse Events Will be Collected
3-6 months
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18 Participants
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Change in Number of Subjects With Adverse Events Will be Collected
9-12 months
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17 Participants
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SECONDARY outcome
Timeframe: baseline, 3-6months and at 9-12 months.Population: 1 patient was not assessed at baseline time point, as the patient had a foley, 4 patients were not assessed at 3-6 months time point, 5 patients were not assessed at 9-12 months time point.
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.
Outcome measures
| Measure |
MR-Guided Prostate SBRT
n=22 Participants
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.
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|---|---|
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Change in Quality of Life Questionnaires Will be Assessed.
Baseline : Urinary incontinence
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80.6 score on a scale
Standard Deviation 22.1
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Change in Quality of Life Questionnaires Will be Assessed.
Baseline : Urinary Irritative/Obstructive
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83.4 score on a scale
Standard Deviation 15.5
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Change in Quality of Life Questionnaires Will be Assessed.
Baseline : Bowel
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96.8 score on a scale
Standard Deviation 5.5
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Change in Quality of Life Questionnaires Will be Assessed.
Baseline : Sexual Function
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8.6 score on a scale
Standard Deviation 14.1
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Change in Quality of Life Questionnaires Will be Assessed.
Baseline : Hormonal
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74.1 score on a scale
Standard Deviation 19.3
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Change in Quality of Life Questionnaires Will be Assessed.
3-6 months : Urinary incontinence
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84.75 score on a scale
Standard Deviation 2.93
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Change in Quality of Life Questionnaires Will be Assessed.
3-6 months : Urinary Irritative/Obstructive
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84.55 score on a scale
Standard Deviation 0.47
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Change in Quality of Life Questionnaires Will be Assessed.
3-6 months : Bowel
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92.2 score on a scale
Standard Deviation 3.2
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Change in Quality of Life Questionnaires Will be Assessed.
3-6 months : Sexual Function
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4.7 score on a scale
Standard Deviation 2.8
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Change in Quality of Life Questionnaires Will be Assessed.
3-6 months : Hormonal
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62.7 score on a scale
Standard Deviation 8.05
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Change in Quality of Life Questionnaires Will be Assessed.
9-12 months : Urinary incontinence
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84.9 score on a scale
Standard Deviation 3.08
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Change in Quality of Life Questionnaires Will be Assessed.
9-12 months : Urinary Irritative/Obstructive
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82.8 score on a scale
Standard Deviation 0.75
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Change in Quality of Life Questionnaires Will be Assessed.
9-12 months : Bowel
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91.6 score on a scale
Standard Deviation 3.68
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Change in Quality of Life Questionnaires Will be Assessed.
9-12 months : Sexual Function
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5.7 score on a scale
Standard Deviation 2.05
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Change in Quality of Life Questionnaires Will be Assessed.
9-12 months : Hormonal
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72.8 score on a scale
Standard Deviation 0.95
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SECONDARY outcome
Timeframe: baseline, 3-6months and at 9-12 months.Population: 1 patient was not assessed at baseline time point, as the patient had a foley, 4 patients were not assessed at 3-6 months time point, 5 patients were not assessed at 9-12 months time point.
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)
Outcome measures
| Measure |
MR-Guided Prostate SBRT
n=22 Participants
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.
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|---|---|
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Change in The International Prostate Symptom Score (I-PSS) Will be Assessed.
Baseline
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10.7 score on a scale
Standard Deviation 7.9
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Change in The International Prostate Symptom Score (I-PSS) Will be Assessed.
3-6 months
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9 score on a scale
Standard Deviation 1.2
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Change in The International Prostate Symptom Score (I-PSS) Will be Assessed.
9-12 months
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12.2 score on a scale
Standard Deviation 1.12
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Adverse Events
MR-Guided Prostate SBRT
Serious adverse events
| Measure |
MR-Guided Prostate SBRT
n=22 participants at risk
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.
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|---|---|
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Skin and subcutaneous tissue disorders
Diffused Pruritic Rash
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4.5%
1/22 • Number of events 1 • Baseline, 3-6 months, 9-12 months
|
Other adverse events
| Measure |
MR-Guided Prostate SBRT
n=22 participants at risk
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.
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|---|---|
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General disorders
Fatigue
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54.5%
12/22 • Number of events 22 • Baseline, 3-6 months, 9-12 months
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Musculoskeletal and connective tissue disorders
Arthralgia
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4.5%
1/22 • Number of events 22 • Baseline, 3-6 months, 9-12 months
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Renal and urinary disorders
Bladder incontinence
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18.2%
4/22 • Number of events 22 • Baseline, 3-6 months, 9-12 months
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Gastrointestinal disorders
Constipation
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9.1%
2/22 • Number of events 22 • Baseline, 3-6 months, 9-12 months
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Vascular disorders
Hot flashes
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40.9%
9/22 • Number of events 22 • Baseline, 3-6 months, 9-12 months
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Musculoskeletal and connective tissue disorders
Lower back pain
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9.1%
2/22 • Number of events 22 • Baseline, 3-6 months, 9-12 months
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Renal and urinary disorders
Weak Urine Stream
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9.1%
2/22 • Number of events 22 • Baseline, 3-6 months, 9-12 months
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Renal and urinary disorders
Nocturia
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9.1%
2/22 • Number of events 22 • Baseline, 3-6 months, 9-12 months
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Renal and urinary disorders
Urinary Frequency
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68.2%
15/22 • Number of events 22 • Baseline, 3-6 months, 9-12 months
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Gastrointestinal disorders
Appetite change
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4.5%
1/22 • Number of events 22 • Baseline, 3-6 months, 9-12 months
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Nervous system disorders
Anxiety
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4.5%
1/22 • Number of events 22 • Baseline, 3-6 months, 9-12 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place