MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer

NCT01094665 | Completed

• 1 other identifier: 09-0689-C
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the safety and feasibility of Magnetic Resonance Image (MRI) guided focal prostate cancer laser thermal ablation in males, ages 40-80 with biopsy confirmed early clinical stage prostate cancer (T1c or T2a) with an identifiable lesion on mutliparametric MRI, with a Prostate Specific Antigen (PSA) of \< 15ng/ml, who have not yet undergone pelvic radiation or hormonal deprivation therapy.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Transrectal Ultrasound Guided Prostate Biopsy

  A 12 core biopsy, plus 2 cores aimed at the ablated lesion will then be preformed to verify the oncological effectiveness of the treatment.

  4 Months Post Treatment

Study Arms (1)

Focal Laser Thermal Therapy

EXPERIMENTAL

Thermal therapy delivered to lesion visible on MRI.

Procedure: MRI Targeted Focal Laser Thermal Therapy

Interventions

MRI Targeted Focal Laser Thermal Therapy PROCEDURE

A 980nm wavelength diode laser will be fired for up to 30 minutes. Temperature probes will be inserted to ensure that the local temperature does not exceed 55 degrees Celsius for more than 5 minutes.

Focal Laser Thermal Therapy

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men 45-80 years of age;
• Histologically proven prostate carcinoma;
• Prostate cancer clinical stage T1c and T2a
• Prostate MRI must confirm area suspicious for cancer in the sector of the positive biopsy;
• Prostate specific antigen (PSA) level less than 15 ng/mL
• cores biopsy, with histologically proven prostate carcinoma, in the suspicious region on MRI.
• IPSS and IIEF complete prior to procedure
• Life expectancy of greater than 5 years, based on co-morbidity not related to prostate cancer.

You may not qualify if:

• 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, TURP, 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 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;
• If the patient is unable to undergo regional anesthesia
• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital, University Health Network

Toronto, Ontario, M5G2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 29, 2010
• Study Start: November 1, 2009
• Primary Completion: October 8, 2015
• Study Completion: October 8, 2015
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

CA (1)