This clinical research study is intended to show that Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) is a safe procedure that can significantly postpone or eliminate the need for patients with intermediate-Risk prostate cancer (PCa) to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation Therapy) for their disease.
Men 40-80 years of age.
Histologically-proven intermediate-risk PCa (Gleason score 7, primary grade ≤ 4).
PCa clinical stage T1c or T2.
MRI/MicroUS site suspicious for cancer or cancer mapped to one prostate lobe.
Maximum dimension of MRI/MicroUS visible tumour > 15 mm.
Patients 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.
Single group
6 month, prospective, interventional single-arm safety and effectiveness study
Procedure/Surgeryx
The TRANBERG|CLS Thermal therapy
DeviceMicro Ultrasound Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS\|Thermal Therapy
Primary Outcome 1:
Number of Participants With Procedure-Related Adverse Events Time Frame: Up to 6 months after procedure Outcome Type: Safety Measure Description: Number and severity of procedure-related adverse events (AEs), graded according to CTCAE v5.0, to evaluate the safety profile of focal Micro-Ultrasound-Guided Focal Laser Ablation (MicroUS-gFLA) in patients with organ-confined intermediate-risk prostate cancer. Unit of Measure: Number of participants
Primary Outcome 2: Technical Success Rate of MicroUS-gFLA
Primary Outcome 2: Technical Success Rate of MicroUS-gFLA Time Frame: At completion of procedure; confirmed during follow-up up to 6 months Outcome Type: Feasibility Measure Description: Proportion of procedures achieving technical success, defined as: successful visualization and MicroUS-guided trocar insertion into the target lesion, and completion of focal laser ablation exactly as planned, as confirmed by intra-procedural imaging and follow-up mpMRI and/or biopsy. Unit of Measure: Percentage of procedures
Secondary Outcome 1 - Change in PSA Level From Baseline
Secondary Outcome 1 - Change in PSA Level From Baseline Time Frame: Baseline to 6 months Outcome Type: Efficacy Measure Description: Change in serum prostate-specific antigen (PSA) level from baseline prior to ablation to 6-month follow-up. Unit of Measure: Change in PSA (ng/mL)
Secondary Outcome 2: Change in Urinary Function (IPSS Score)
Secondary Outcome 2: Change in Urinary Function (IPSS Score) Time Frame: Baseline, 3 months, and 6 months Outcome Type: Functional Measure Description: Change in urinary function measured using the International Prostate Symptom Score (IPSS). Unit of Measure: Change in score (IPSS scale)
Secondary Outcome 3: Change in Erectile Function (IIEF-15 Score)
Secondary Outcome 3: Change in Erectile Function (IIEF-15 Score) Time Frame: Baseline, 3 months, and 6 months Outcome Type: Functional Measure Description: Change in erectile function measured using the International Index of Erectile Function-15 (IIEF-15) questionnaire. Unit of Measure: Change in score (IIEF-15 scale)
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University Health Network, Toronto
Lead sponsor
Exact Imaging
Collaborator
Clinical Laserthermia Systems AB
Collaborator
