Micro-ultrasound-Guided Focal Laser Ablation for Intermediate-Risk Prostate Cancer: Safety & Effectiveness

University Health Network, Toronto7 enrolled

Overview

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.

Prostate cancer is the most common cancer in men, and a large proportion of these diagnoses are of the low or intermediate risk type that are amenable to a minimally invasive approach to treatment such as Focal Therapy. If successful, this study will show that trans-perineal interstitial laser focal therapy of the prostate could be offered over a wider community setting than only at a major hospital as an Magnetic Resonance Imaging (MRI), to confidently locate the Index Lesion would not be required because MicroUS is showing the same potential to visualize the lesion. MicroUS-guided focal laser ablation would be a simpler treatment than the complexity required under MRI, it could be offered in communities that might not have local access to MRI facilities and could be offered to individuals who are contra-indicated for MRI for such reasons as having metallic implants or severe claustrophobia.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer (Adenocarcinoma)Low and Intermediate Risk Prostate Cancer

Interventions

6 month, prospective, interventional single-arm safety and effectiveness studyPROCEDURE

The TRANBERG|CLS Thermal therapyDEVICE

Micro Ultrasound Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS\|Thermal Therapy

Eligibility

Sex: MALEMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 ≤15mm. * Suspicious site on Prostate MRI/MicroUS must coincide with sector positive for cancer on biopsy. * Prostate specific antigen (PSA) level \< 15 ng/mL. * IPSS, ICIQ-UI-SF, IIEF-15 questionnaires completed prior to the procedure. * Life expectancy of greater than 10 years, based on co-morbidity not related to PCa. Exclusion Criteria: * 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. * Patients who have received or are receiving chemotherapy for prostate carcinoma. * Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive) including HIFU, TUNA, RITA, microwave, cryotherapy or any curative treatment. * Patients who have undergone radiation therapy for PCa or to the pelvis. * Any condition or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies). * Patients with a history of non-compliance with medical therapy and/or medical recommendations. * Patients who are unwilling or unable to complete the patient self-assessment questionnaires. * Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition. * Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days. * Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent)

Locations (1)

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: From enrollment to the end of treatment at 6 months.

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

Time frame: From enrollment to the end of treatment at 6 months

Secondary Outcomes

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)

Time frame: From enrollment to the end of treatment at 6 months.

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)

Central Contacts

Kateri Corr

CONTACT

416-946-4501 kateri.corr@uhn.ca

Sangeet Ghai, MD

CONTACT

416-340-4656 sangeet.ghai@uhn.ca

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.