MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer (FLTT002)

March 7, 2018 updated by: University Health Network, Toronto

Phase 1 Study of MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single center, single arm, open-label study to evaluate the safety and feasibility of MRI guided focal prostate cancer laser ablation in patients with a focus of prostate cancer who has not yet received treatment for their cancer. Patients fulfilling the inclusion criteria and having none of the clinical exclusion criteria will be enrolled into the study after they (or their legal representative) have signed the informed consent form. No control group will be utilized and all patients will receive MRI guided FLA for their focal prostate cancer. As part of the screening process, patients will provide a medical history and undergo a physical examination, including a digital rectal examination (DRE). At the first visit, patients will also be given a copy of the informed consent, and a copy of quality of life and performance questionnaires to assess urinary, rectal, and erectile functions (IPSS questionnaire for urinary, IIEF5 questionnaire for erectile function, for all). MR imaging at visit 2 will serve to determine if a single site of prostate cancer can be localized. At visit 3, 12 cores transrectal us guided prostate biopsy will confirm yet again that this is a unilateral, unifocal histologically proven tumour in the site recognized on the MRI. On preoperative examination (visit 4) - blood and urine samples will be taken prior to procedure. Visit 5 - the focal treatment will be performed under regional or general anesthesia, or conscious sedation, (as determined by the anesthesiologist) in the TGH research 1.5T MRI suite. MR guided FLA procedure is similar to MR guided brachytherapy, with fibers and probes inserted transperineally outside the bore of the MR and then the patient is moved inside the bore to verify position before deploying the laser. The treatment is expected to last 2-3 hours, and patients expected to have no pain during the whole procedure. Laser ablation will be monitored using MR thermometry14, 15.An MRI scan will be done immediately after the ablation, as initial assessment for ensuring complete treatment of the target volume, as well as ensuring that treatment does not extend to critical structures.

The size and location of the lesion will be compared to the planned target volume and the proximity of the lesion to the urethra and rectum. If the lesion does not encompass the target volume, and is still a safe distance from either critical structure, FLA may be continued.

On day 3, 7, 30, and 120 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. Free/Total PSA will be monitor on visit -1 and after the treatment on day 7, 30 and 120, in order to try to understand the effect of FLA on PSA. Four months after the focal procedure, a further 12 cores biopsy, plus 2 cores aimed to the ablated lesion will then be preformed to verify the oncological effectiveness of the treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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, University Health Network

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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
  • 12 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.

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, 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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Focal Laser Thermal Therapy
Thermal therapy delivered to lesion visible on MRI.
Procedure: MRI Targeted Focal Laser Thermal Therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Transrectal Ultrasound Guided Prostate Biopsy
Time Frame: 4 Months Post Treatment
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09-0689-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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