MRI guided laser treatment for early stage prostate cancer

MRI Guided Focal Laser Ablation of Prostate Cancer

This study is testing if a new MRI-guided laser treatment can help men with early stage prostate cancer avoid more invasive procedures and still maintain a good quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 40 Years to 80 Years
• Sex: Male
• Sponsor: University Health Network, Toronto (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT03650595 on ClinicalTrials.gov

What this trial studies

This clinical research focuses on using MRI guided focal laser ablation (MRgFLA) to treat patients with low to intermediate risk prostate cancer. The study aims to evaluate the effectiveness of this procedure in eliminating or postponing the need for more invasive treatments like radical prostatectomy or radiation therapy. Participants will undergo repeated MRI and prostate biopsy to assess the treatment's success, with previous studies indicating minimal side effects and a high rate of patients remaining on active surveillance. The primary goal is to demonstrate that MRgFLA can safely manage prostate cancer while maintaining quality of life.

Who should consider this trial

Good fit: Ideal candidates are men aged 40-80 with histologically proven low-intermediate risk prostate cancer.

Not a fit: Patients who have received prior prostate surgery or androgen suppression therapy may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could allow patients to avoid more invasive procedures and their associated side effects.

How similar studies have performed: Previous studies have shown promising results for similar approaches, indicating that MRgFLA may be a viable option for managing low-intermediate risk prostate cancer.

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

Where this trial is running

Toronto, Ontario

• Sangeet Ghai, MD — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Sangeet Ghai, MD — Director; Biopsy Centre, Abdominal Division and Joint Department of Medical Imaging
• Study coordinator: Sangeet Ghai, MD

Conditions: Prostate Cancer, Low and Intermediate Risk Prostate Cancer, MRI, Focal Laser Ablation, MR-Guided Focal Laser Ablation