Trial Outcomes & Findings for MRI Guided Prostate Cancer Focal Laser Ablation (NCT NCT03634579)

Last Updated: 2020-03-23

Results Overview

Efficacy is assessed by recurrence rate at 1 year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation

Recruitment status

TERMINATED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2020-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	MRI-guided Focal Laser Ablation Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
Overall Study STARTED	9
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	MRI-guided Focal Laser Ablation Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
Overall Study study termination	9

Baseline Characteristics

MRI Guided Prostate Cancer Focal Laser Ablation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRI-guided Focal Laser Ablation n=9 Participants Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Data were not collected/analyzed due to the study termination

Efficacy is assessed by recurrence rate at 1 year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 24 months

Safety is assessed by percentage of grade 3 or higher complications or adverse events (AE) as defined as National cancer institute's common toxicity criteria version 4: incontinence or urinary retention necessitating surgical intervention or new-onset erectile dysfunction not responsive to medication.Grade refers to the severity of the AE. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.Grade 2 Moderate; minimal, local or non invasive intervention indicated; limiting age appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.

Outcome measures

Outcome measures
Measure	MRI-guided Focal Laser Ablation n=9 Participants Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
Percentage of Grade 3 or Higher Complications as Defined as National Cancer Institute's Common Toxicity Criteria Version 4 Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation	0 percentage of grade 3 or higher complica

PRIMARY outcome

Timeframe: 3 weeks follow up

Change in erectile function is assessed using Sexual Health Inventory For Men (SHIM) for erectile function. There are 5 questions and each question has 5 possible responses. If the patient's score is 21 or less, erectile dysfunction (ED) is present.

Outcome measures

Outcome measures
Measure	MRI-guided Focal Laser Ablation n=9 Participants Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
Number of Subjects Experienced Change in Erectile Function	1 Participants

PRIMARY outcome

Timeframe: 3 weeks follow up

Urinary function will be assessed using International Prostate Symptom Score (IPSS) assessment for urinary function. The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions (maximum score 35) concerning urinary symptoms and one question concerning quality of life. Any score \> 1 indicates presence of urinary dysfunction, higher score indicates increased severity.

Outcome measures

Outcome measures
Measure	MRI-guided Focal Laser Ablation n=9 Participants Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
Number of Subjects Experienced Change in Urinary Function	3 Participants

SECONDARY outcome

Timeframe: Up to 24 months

Population: Data were not collected/analyzed due to the study termination

Efficacy is assessed by recurrence rate at end of 2nd year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation

Outcome measures

Outcome data not reported

Adverse Events

MRI-guided Focal Laser Ablation

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MRI-guided Focal Laser Ablation n=9 participants at risk Subjects will undergo MRI Guided Focal Laser Interstitial Thermal Ablation of localized low and intermediate risk prostate cancer.
Reproductive system and breast disorders Erectile disfunction	11.1% 1/9 • Number of events 1 • 2 years
Renal and urinary disorders Urinary incontinence	33.3% 3/9 • Number of events 3 • 2 years

Additional Information

Sherif Nour

Emory University

Phone: 404-778-3800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place