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

University Health Network, Toronto

Status: Enrolling

Conditions: Prostate Cancer (Adenocarcinoma); Low and Intermediate Risk Prostate Cancer

Treatments: Procedure: 6 month, prospective, interventional single-arm safety and effectiveness study; Device: The TRANBERG|CLS Thermal therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07339943

21-6189

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 7 estimated patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Single-Arm Prospective Clinical Trial

Experimental group

Description:

This is a single arm study where patients with intermediate risk MR visible locally confined prostate cancer will be treated with Micro-Ultrasound Guided Focal Laser Ablation. Following treatment, the patients will be assessed by MRI and Biopsy at 6 months with PSA.

Treatment:

Device: The TRANBERG|CLS Thermal therapy

Procedure: 6 month, prospective, interventional single-arm safety and effectiveness study