Trial Outcomes & Findings for Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer (NCT NCT01686958)
NCT ID: NCT01686958
Last Updated: 2020-02-11
Results Overview
All reported adverse events were recorded. The frequency was measured as the number of study participants who experienced a treatment/device related adverse event after receiving treatment delivery with PAD-105, the investigational device.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
12 months from the Treatment Date
Results posted on
2020-02-11
Participant Flow
Participant milestones
| Measure |
MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Technology developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.
Study is a prospective, multi-center, single arm trial conducted in US, Canada and Europe. All subjects received the same treatment.
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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29
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Technology developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.
Study is a prospective, multi-center, single arm trial conducted in US, Canada and Europe. All subjects received the same treatment.
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer
Baseline characteristics by cohort
| Measure |
MR-Guided Transurethral US Ablation
n=30 Participants
MR-Guided Transurethral US Ablation of Prostate Tissue
MR-Guided Transurethral US Ablation of Prostate Tissue: The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prescribed prostate tissue.
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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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2 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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28 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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30 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Multi-racial
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1 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
White/Caucasian
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29 Participants
n=5 Participants
|
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Region of Enrollment
Canada
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12 participants
n=5 Participants
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Region of Enrollment
United States
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4 participants
n=5 Participants
|
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Region of Enrollment
Germany
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14 participants
n=5 Participants
|
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Subjects with erections sufficient for penetration at Baseline
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21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months from the Treatment DatePopulation: The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.
All reported adverse events were recorded. The frequency was measured as the number of study participants who experienced a treatment/device related adverse event after receiving treatment delivery with PAD-105, the investigational device.
Outcome measures
| Measure |
MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
n=30 Participants
The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.
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|---|---|
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Safety - Evaluate the Frequency of Treatment Related Adverse Events
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30 Participants
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PRIMARY outcome
Timeframe: 12 months from the Treatment DatePopulation: The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.
Severity of treatment/device related adverse events were evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard (version 4), published by the National Cancer Institute (NCI). There was no intraoperative complication, no rectal injury or fistula and no severe urinary incontinence. No Grade 4 (G4) or higher adverse events and only one attributable Grade 3 (G3) event; reported below. The common and significant Grade 1 (G1) and Grade 2 (G2) genitourinary events have also been reported.
Outcome measures
| Measure |
MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
n=30 Participants
The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.
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|---|---|
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Safety - Evaluate the Severity of Treatment Related Adverse Events
Hematuria - G1
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43 % of subjects
Interval 25.0 to 63.0
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Safety - Evaluate the Severity of Treatment Related Adverse Events
Hematuria - G2
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6.7 % of subjects
Interval 0.8 to 22.0
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Safety - Evaluate the Severity of Treatment Related Adverse Events
Urinary tract infection - G2
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33 % of subjects
Interval 17.0 to 53.0
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Safety - Evaluate the Severity of Treatment Related Adverse Events
Epididymitis - G3
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3.3 % of subjects
Interval 0.1 to 17.0
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Safety - Evaluate the Severity of Treatment Related Adverse Events
Urinary retention - G1
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10 % of subjects
Interval 2.1 to 27.0
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Safety - Evaluate the Severity of Treatment Related Adverse Events
Urinary retention - G2
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17 % of subjects
Interval 5.6 to 35.0
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Safety - Evaluate the Severity of Treatment Related Adverse Events
Obstructive micturition
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10 % of subjects
Interval 2.1 to 27.0
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Safety - Evaluate the Severity of Treatment Related Adverse Events
Urinary incontinence - G1
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3.3 % of subjects
Interval 0.1 to 17.0
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Safety - Evaluate the Severity of Treatment Related Adverse Events
Urinary incontinence - G2
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10 % of subjects
Interval 2.1 to 27.0
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Safety - Evaluate the Severity of Treatment Related Adverse Events
Urinary stricture - G1
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3.3 % of subjects
Interval 0.1 to 17.0
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Safety - Evaluate the Severity of Treatment Related Adverse Events
Urinary stricture - G2
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3.3 % of subjects
Interval 0.1 to 17.0
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SECONDARY outcome
Timeframe: On Treatment DatePopulation: The analysis population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.
Conformal thermal coagulation of prostate tissue will be determined quantitatively using measures of targeting accuracy which compare the spatial difference between the target volume and target temperature isotherm determined from MR thermometry images acquired during treatment.
Outcome measures
| Measure |
MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
n=30 Participants
The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.
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|---|---|
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Feasibility - Evaluate the Effectiveness of the Investigational System to Thermally Coagulate Prostate Tissue Conforming to the Target Volume With a High Degree of Accuracy and Precision
Thermal ablation accuracy
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0.1 mm
Standard Deviation 0.4
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Feasibility - Evaluate the Effectiveness of the Investigational System to Thermally Coagulate Prostate Tissue Conforming to the Target Volume With a High Degree of Accuracy and Precision
Thermal ablation precision
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1.3 mm
Standard Deviation 0.4
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OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months from the Treatment DatePopulation: One patient did not complete the 12-month visit, therefore 29 patients were included in this analysis.
Evaluate the effectiveness of the treatment to achieve disease control at 12 months based on biopsy results.
Outcome measures
| Measure |
MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
n=29 Participants
The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.
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|---|---|
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Treatment Efficacy - Biopsy
Positive biopsy (clinically significant disease)
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9 Participants
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Treatment Efficacy - Biopsy
Overall absence of clinically significant disease
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20 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: As per the Study Schedule, measured at 1-month, 3-months, 6-months and 12-months from the Treatment Date compared to BaselineBased on measurements obtained at each study visit, characterize the pattern of PSA response within the first 12 months following treatment in comparison to baseline.
Outcome measures
| Measure |
MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
n=30 Participants
The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.
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|---|---|
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Treatment Efficacy - PSA
PSA @ Baseline
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5.8 ng/ml
Interval 3.8 to 8.0
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Treatment Efficacy - PSA
PSA @ 1 month
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0.8 ng/ml
Interval 0.5 to 1.1
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Treatment Efficacy - PSA
PSA @ 3 months
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0.9 ng/ml
Interval 0.4 to 1.7
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Treatment Efficacy - PSA
PSA @ 6 months
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0.8 ng/ml
Interval 0.4 to 1.1
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Treatment Efficacy - PSA
PSA @ 12 months
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0.8 ng/ml
Interval 0.6 to 1.1
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12-months post TreatmentPopulation: One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.
Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, International Prostate Symptom Score (IPSS), which focuses on urinary symptoms. Total Score: 0 - 35 0-7 - mildly symptomatic 8-19 - moderately symptomatic 20-35 - severely symptomatic
Outcome measures
| Measure |
MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
n=30 Participants
The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.
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|---|---|
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Treatment Efficacy - Quality of Life - Urinary Symptoms
IPSS @ Baseline
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8 units on a scale
Interval 5.0 to 13.0
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Treatment Efficacy - Quality of Life - Urinary Symptoms
IPSS @ 12 months
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5 units on a scale
Interval 4.0 to 7.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12-months post TreatmentPopulation: One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.
Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Erectile Function EF domain of the International Index of Erectile Function (IIEF-15), which focuses on erectile symptoms. Minimum score value - 0 Maximum score value - 30 A higher score corresponds to a better outcome; lower score indicative of erectile dysfunction
Outcome measures
| Measure |
MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
n=30 Participants
The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.
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|---|---|
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Treatment Efficacy - Quality of Life - Erectile Function
IIEF-EF-15 @ Baseline
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13 units on a scale
Interval 6.0 to 28.0
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Treatment Efficacy - Quality of Life - Erectile Function
IIEF-EF-15 @ 12 months
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13 units on a scale
Interval 5.0 to 25.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 12-months post TreatmentPopulation: One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.
Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Bowel Habits domain of the UCLA Prostate Cancer Index Short Form (UCLA-PCl-SF-BH), which focuses on bowel symptoms. Minimum score value - 0 Maximum score value - 100 A higher score corresponds to better outcome
Outcome measures
| Measure |
MR-Guided Transurethral Ultrasound Ablation of Prostate Tissue
n=30 Participants
The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is whole gland ablation.
Treatment delivery using an investigational medical device, PAD-105, a MRI-guided transurethral ultrasound whole gland prostate ablation.
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|---|---|
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Treatment Efficacy - Quality of Life - Bowel Habits
UCLA-PCI-SF-BH @ Baseline
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100 units on a scale
Interval 90.0 to 100.0
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Treatment Efficacy - Quality of Life - Bowel Habits
UCLA-PCI-SF-BH @ 12 months
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100 units on a scale
Interval 100.0 to 100.0
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Adverse Events
MR-Guided Transurethral US Ablation
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MR-Guided Transurethral US Ablation
n=30 participants at risk
MR-Guided Transurethral US Ablation of Prostate Tissue
MR-Guided Transurethral US Ablation of Prostate Tissue: The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prescribed prostate tissue.
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|---|---|
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Infections and infestations
Epididymitis
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3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Renal and urinary disorders
Urinary retention
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3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Other adverse events
| Measure |
MR-Guided Transurethral US Ablation
n=30 participants at risk
MR-Guided Transurethral US Ablation of Prostate Tissue
MR-Guided Transurethral US Ablation of Prostate Tissue: The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prescribed prostate tissue.
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|---|---|
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Renal and urinary disorders
Hematuria
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50.0%
15/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Renal and urinary disorders
Urinary tract infection
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33.3%
10/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Infections and infestations
Epididymitis
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3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Renal and urinary disorders
Urinary retention
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26.7%
8/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Renal and urinary disorders
Urinary incontinence
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13.3%
4/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Renal and urinary disorders
Urinary stricture
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6.7%
2/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Gastrointestinal disorders
Rectal pain
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3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Gastrointestinal disorders
Fecal straining
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Gastrointestinal disorders
Bloating
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10.0%
3/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Renal and urinary disorders
Bladder inflammation
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3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Renal and urinary disorders
Bladder irritability
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3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Renal and urinary disorders
Bladder spasm
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16.7%
5/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Renal and urinary disorders
Edema: penile and/or scrotal
|
16.7%
5/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Edema: testicular
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
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Renal and urinary disorders
Hemorrhagic cystitis
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
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Renal and urinary disorders
Increased post void urinary residual in bladder
|
6.7%
2/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Nocturia
|
6.7%
2/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Obstructive micturition
|
10.0%
3/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Penile discharge or bleeding
|
33.3%
10/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
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Renal and urinary disorders
Prostate anatomical change or discoloration
|
23.3%
7/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Prostate inflammation
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Prostate tissue sloughing
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Scarred urethra
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Urethral skin tags
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
10/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Urinary hesitancy
|
23.3%
7/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Urinary sensation to void
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Urinary urgency
|
40.0%
12/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Urine abnormality
|
6.7%
2/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Reproductive system and breast disorders
Erectile dysfunction or worsening erectile function
|
36.7%
11/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
23.3%
7/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Reproductive system and breast disorders
Hematospermia
|
6.7%
2/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
General disorders
Distended abdomen
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
General disorders
Ear drainage
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
General disorders
Fatigue
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Infections and infestations
Fever
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
General disorders
Hematoma or Ecchymosis: Buttock
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
General disorders
Hemtoma or Ecchymosis: Femur
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
General disorders
Hematoma or Ecchymosis: Sacral bone
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
General disorders
Hyperkalemia
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
General disorders
Patient movement at onset of treatment
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
General disorders
Raised lump: Back
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
General disorders
Sore throat
|
3.3%
1/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Dysuria
|
20.0%
6/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
General disorders
Pain: Back, hips, shoulder, upon catheter removal
|
16.7%
5/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
|
|
Renal and urinary disorders
Pain: Bladder, penile, perineal, prostate, urethral
|
40.0%
12/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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General disorders
Suprapubic Catheter: bleeding around SPC, urine leaking around SPC, blocked SPC, catheter fell out
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16.7%
5/30 • 12 months
Adverse events were assessed and documented at each follow-up visit. The severity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).
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Additional Information
Results disclosure agreements
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- Publication restrictions are in place
Restriction type: OTHER