MRI Guided Focal Laser Ablation of Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-80
SponsorUniversity Health Network, Toronto
About this trial
This clinical research study is designed to determine the ability of in bore MRI guided Focal Laser Ablation (MRgFLA) in patients with early stage carcinoma of prostate. The results will be evaluated by repeated MRI and prostate biopsy. Previous prospective development study demonstrated that FLA may be a viable option for men with low-intermediate risk prostate cancer. The vast majority of patients undergoing this treatment experienced minimal side effects with no peri-operative complications. Over 80% of patients treated with MRgFLA remain on AS and were able to avoid radical therapy at mean follow up duration of 3 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men 40-80 years of age
Histologically proven low-intermediate risk prostate carcinoma; (Gleason score ≤ 7, primary grade ≤ 4;)
Prostate cancer clinical stage T1c and T2
MR site suspicious for cancer or cancer mapped to one lobe of the prostate using the 3D hybrid TRUS device
Disqualifiers
Medically unfit for focal therapy of the prostate
Patients who are unwilling or unable to give informed consent;
Patients who have received androgen suppression therapy
Patients who have received or are receiving chemotherapy for prostate carcinoma;
Trial design
Design model
Single group
Treatments tested in this trial
The TRANBERGCLS|Thermal Therapy
DeviceMRI Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS\|Thermal Therapy
Treatment groups
102 Participants
are divided into 1 treatment groupGroup A: Single arm prospective clinical trialExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment)
Clinically significant PCa will be defined as recurrent/residual Gleason 3+4 or higher, and/or high-volume Gleason 6 disease found at 6-month biopsy.
Time frame
6 months after treatment completion2
The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment)
Clinically significant PCa will be defined as recurrent/residual Gleason 3+4 or higher, and/or high-volume Gleason 6 disease found at 24-month biopsy.
Time frame
24 months after treatment completionSecondary outcomes
1
Treatment effect on patients' Quality of Life (QoL), the following validated self-reported urogenital functioning assessment instruments will be used before and following treatment at pre-specified interval
Validate Patient-Reported Questionnaire (International Prostate Symptom Score, scale from 0-7 mild, 8-19 moderate, 20-35 severe symptoms, higher values being worse, averages at different time points will be noted to assess improvement, decline or baseline) will be completed by participants throughout the study to assess Health Related Quality of Life.
Time frame
Baseline before treatment, 30 days, 6 months, 12 months and at 24 months following treatment2
Treatment effect on patients' Quality of Life (QoL), the following validated self-reported urogenital functioning assessment instruments will be used before and following treatment at pre-specified interval
Validate Patient-Reported Questionnaire (International Index of Erectile Function-15, higher scores are better, averages at each specified interval will be taken once all subjects reach the interval and study completion) will be completed by participants throughout the study to assess Health Related Quality of Life.
Time frame
Baseline before treatment, 30 days, 6 months, 12 months and at 24 months following treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Health Network, Toronto
Lead sponsor
Clinical Laserthermia Systems AB
Collaborator
Source ClinicalTrials.gov