Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 550 for:    prostate cancer | ( Map: Canada )

MRI Guided Focal Laser Ablation of Prostate Cancer (MRgFLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03650595
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Clinical Laserthermia Systems AB
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Low and Intermediate Risk Prostate Cancer Device: The TRANBERGCLS|Thermal Therapy Not Applicable

Detailed Description:
Study Objectives are to evaluate the proportion of patients with low-intermediate risk prostate cancer undergoing focal laser ablation (MRgFLA) prostate treatment who will be free of clinically significant PCa, when using a > 5mm margins around the MR visible tumor in defining the ablation contour. The rationale of the study is to show that MRgFLA is a safe procedure that can significantly postpone or eliminate the need for patients with Low-Intermediate Risk prostate cancer to undergo a definitive treatment (i.e., Radical Prostatectomy or Radiation therapy) for their disease. Study population: patients with Low-Intermediate Risk Prostate Cancer who are willing to take part in the study and meet study eligibility criteria. Primary Study Objective is to show that MRgFLA can significantly reduce the need for definitive treatment (e.g., Radical Prostatectomy, or Radiation therapy) and is a safe procedure for patients with Low-Intermediate Risk Prostate Cancer defined in the current protocol as 1) Gleason score 6 and 7 (=3+4 or 4+3; No Grade 5 pattern), and 2) T1-T2, N0, M0.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, open-label single-arm effectiveness study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MRI Guided Focal Laser Ablation of Prostate Cancer
Actual Study Start Date : March 29, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Single arm prospective clinical trial
This is a single arm study where patients with low-intermediate risk MR visible locally confined prostate cancer will be treated with focal laser ablation under MRI guidance in the magnet. Following treatment, the patients will be assessed by MRI and Biopsy at 6 months and at 2 years, with PSA assessment at regular intervals during the time
Device: The TRANBERGCLS|Thermal Therapy
MRI Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS|Thermal Therapy




Primary Outcome Measures :
  1. The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment) [ Time Frame: 6 months after treatment completion ]
    Clinically significant PCa will be defined as recurrent/residual Gleason 3+4 or higher, and/or high volume Gleason 6 disease found at 6 month biopsy.

  2. The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment) [ Time Frame: 24 months after treatment completion ]
    Clinically significant PCa will be defined as recurrent/residual Gleason 3+4 or higher, and/or high volume Gleason 6 disease found at 24 month biopsy.


Secondary Outcome Measures :
  1. Treatment effect on patients' Quality of Life (QoL), the following validated self-reported urogenital functioning assessment instruments will be used before and following treatment at pre-specified interval [ Time Frame: 6 months and at 24 months following treatment ]
    Validate Patient-Reported Questionnaire (IPSS) will be completed by participants throughout the study to assess HRQOL.

  2. Treatment effect on patients' Quality of Life (QoL), the following validated self-reported urogenital functioning assessment instruments will be used before and following treatment at pre-specified interval [ Time Frame: 6 months and at 24 months following treatment ]
    Validate Patient-Reported Questionnaire (IIEF-15) will be completed by participants throughout the study to assess HRQOL.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men with prostate cancer
Accepts Healthy Volunteers:   No
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 less than 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 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;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650595


Contacts
Layout table for location contacts
Contact: Sangeet Ghai, MD 416-340-4800 ext 3385 sangeet.ghai@uhn.ca
Contact: Kateri Corr, RN 416-946-4501 ext 5501 kateri.corr@uhn.ca

Locations
Layout table for location information
Canada, Ontario
Sangeet Ghai, MD Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Sangeet Ghai, MD    416-340-4800 ext 3385    sangeet.ghai@uhn.ca   
Contact: Kateri Corr, RN    416-946-4501 ext 5501    kateri.corr@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Clinical Laserthermia Systems AB

Layout table for additonal information
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03650595     History of Changes
Other Study ID Numbers: 15-9002
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Health Network, Toronto:
MRI
Focal Laser Ablation
MR-Guided Focal Laser Ablation

Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases