MRI Targeted Focal Thermal Therapy of Prostate Cancer in Prostate Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Prostate Cancer

Intervention / Treatment

Procedure: MRI Targeted Focal Thermal Therapy of Prostate Cancer

Detailed Description

This is a single center, single arm, open-label Phase I study to establish the safety of interstitial laser thermal therapy (ILTT) in patients with a single site of low grade (Gleason <7) prostate cancer who have not yet received treatment for their cancer. No control group will be utilized and all patients will receive laser thermal therapy. The patient will undergo multimode MRI to determine if a single site of prostate cancer can be localized by this technique and to localize the tumor in 3 dimensions within the prostate. A multicore (12 + cores) mapping transrectal ultrasound guided biopsy of the prostate would then confirm that no other sites of cancer exist.

Each patient will complete quality of life and performance questionnaires. ILLT will be performed under general anesthetic in a procedure similar to brachytherapy, using transrectal ultrasound to guide insertion of the laser and monitoring probes into the sector containing the cancer as visualized by the MR scan. Following the procedure, patients will be assessed for clinical signs of urinary, rectal, and erectile complications and will complete validated self-assessment tools on these functions. MRI at 7 days and MRI and biopsy at 6 months will be used to assess the extent of tissue effect and presence of cancer due to ILTT. Patients will remain on standard Watchful Waiting surveillance for any further sign of disease progression. ILLT will not restrict any future treatment of prostate cancer.

To minimize the treatment risk, participants in the trial will be staged according to location of the disease in the prostate. The first 3 participants recruited to the trial will have targeted loci well separated from the urethra, erectile nerves and the rectum, and so treatment in this region poses minimal risk of injury to these vital structures. Lesions sizes measured in this initial stage will be used in planning fiber placement in the three remaining stages, in which fiber placement is closer to critical structures such as the urethra (Stage 2), erectile nerves (Stage 3) and rectum (Stage 4).

Study Type

Interventional

Enrollment (Actual)

12

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Toronto, Ontario, Canada, M5G2M9
    - Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Men > 18 years of age;
Histologically-proven prostate carcinoma;
Prostate cancer clinical stage T1c
Only one sector of the prostate demonstrating prostate cancer with no more than 1 core positive
Gleason score <7 ;
Each core must range between of 10 to 50% adenocarcinoma.
Prostate MRI must confirm area suspicious for cancer in the sector of the positive biopsy;
A minimum of six (6) weeks between the prostate biopsy and the Inclusion Visit;
Prostate specific antigen (PSA) level £ 10 ng/mL
PORPUS, IPSS, and IIEF complete prior to procedure
Prostate volume < 60 cc as measured by ultra sound;
Uroflow >12 cc/sec with post void residual < 100 cc.
Life expectancy of greater than 5 years, based on co-morbidity not related to prostate cancer.

Exclusion Criteria:Patients with any of the following exclusion criteria will be excluded from study participation:

Patients who are unwilling or unable to give informed consent;
Patients with foci location in the Apex of the prostate or isolated transition zone cancers
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 whose has undergone radiation therapy for prostate cancer
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;
Myocardial infarction, transient ischemic attack or stroke, within 6 months prior to the study, Unstable or uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias
Chronic or acute prostititis, neuroginic 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;
All medications that cause a decrease clotting, vasoconstriction or platelet aggregation, must be stopped prior to treatment.
History of Colon Cancer or Colon Surgery preformed
If the patient is unable to undergo 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical assessment of: urinary, rectal, erectile function Time Frame: 1 week, 1 month, 3 months, 6 months post procedure	1 week, 1 month, 3 months, 6 months post procedure
validated self assessment tools of urinary, rectal, erectile function. Time Frame: 1 month, 3 months, 6 months post procedure	1 month, 3 months, 6 months post procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Lesion size measured with 7-day MRI Time Frame: One week post procedure	One week post procedure
6 month prostate biopsy Time Frame: 6 months post procedure	6 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

Principal Investigator: John Trachtenberg, M.D., University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

March 16, 2007

First Submitted That Met QC Criteria