Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
MALE
NCT03650595

MRI Guided Focal Laser Ablation of Prostate Cancer

Led by University Health Network, Toronto · Updated on 2024-08-12

102

Participants Needed

1

Research Sites

535 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

C

Clinical Laserthermia Systems AB

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical research study is designed to determine the ability of in bore MRI guided Focal Laser Ablation (MRgFLA) in patients with early stage carcinoma of prostate. The results will be evaluated by repeated MRI and prostate biopsy. Previous prospective development study demonstrated that FLA may be a viable option for men with low-intermediate risk prostate cancer. The vast majority of patients undergoing this treatment experienced minimal side effects with no peri-operative complications. Over 80% of patients treated with MRgFLA remain on AS and were able to avoid radical therapy at mean follow up duration of 3 years.

CONDITIONS

Official Title

MRI Guided Focal Laser Ablation of Prostate Cancer

Who Can Participate

Age: 40Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men aged 40 to 80 years
  • Histologically confirmed low to intermediate risk prostate cancer with Gleason score 7 or less, primary grade 4 or less
  • Clinical stage T1c or T2 prostate cancer
  • MRI-visible tumor suspicious for cancer or cancer mapped to one prostate lobe
  • Size of MRI-visible tumor less than 20 millimeters
  • Suspicious MRI site matches biopsy positive cancer sector
  • Prostate specific antigen (PSA) level less than 15 ng/mL
  • Completion of IPSS, ICIQ-UI-SF, and IIEF questionnaires before procedure
  • Life expectancy greater than 10 years based on non-prostate cancer related health
Not Eligible

You will not qualify if you...

  • Medically unfit for focal prostate therapy
  • Unable or unwilling to give informed consent
  • Prior androgen suppression therapy
  • Prior or current chemotherapy for prostate cancer
  • Previous prostate surgery including traditional, endoscopic, minimally invasive, or curative treatments
  • Prior radiation therapy to prostate or pelvis
  • Significant cardiovascular conditions, allergies, or illnesses that may affect study results or increase risk
  • History of noncompliance with medical treatments or recommendations
  • Unable or unwilling to complete self-assessment questionnaires
  • Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or urinary symptoms preventing normal urination
  • Participation in another clinical trial or investigational treatment within past 90 days
  • Contraindications to MRI such as pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, or allergy to MRI contrast
  • Any other illness or condition that may confound study results or increase patient risk per investigator judgment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sangeet Ghai, MD

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

S

Sangeet Ghai, MD

CONTACT

K

Kateri Corr, RPN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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