MRI Guided Focal Laser Ablation of Prostate Cancer

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Aug 24, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MRI-guided Focal Laser Ablation (MRgFLA) for men with early-stage prostate cancer that is considered low to intermediate risk. The aim is to see how effective this treatment is in targeting and destroying cancer cells while minimizing side effects. Previous studies have shown promise, with many patients experiencing few complications and being able to avoid more invasive treatments for an average of three years after the procedure.

To participate in this trial, men aged 40 to 80 with a specific type of prostate cancer (with a certain score and size) may qualify. Participants will undergo MRI scans and a biopsy to monitor their cancer before and after treatment. It’s important to note that individuals with certain medical conditions or prior treatments may not be eligible for this study. Those who join can expect regular follow-ups to assess their health and the effectiveness of the treatment. Overall, this trial aims to provide a less invasive option for managing prostate cancer while maintaining a good quality of life.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Size of MR visible tumor \<20mm
• • Suspicious site on Prostate MRI must coincide with sector positive for cancer on biopsy
• • Prostate specific antigen (PSA) level \<15 ng/mL
• • IPSS, ICIQ-UI-SF, IIEF complete prior to procedure
• • Life expectancy of greater than 10 years, based on co-morbidity not related to prostate cancer.
• Exclusion Criteria:
• • 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 prostate cancer 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 noncompliance 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)
• • Any condition, or history of illness that, in the opinion of the investigator will confound or increase the patient risk during the study