MRI Guided Focal Laser Ablation of Prostate Cancer

NCT03650595 | Recruiting

• 1 other identifier: 15-9002
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Low and Intermediate Risk Prostate Cancer

Keywords

MRI; Focal Laser Ablation; MR-Guided Focal Laser Ablation

Outcome Measures

Primary Outcomes (2)

• The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment)

  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.

  6 months after treatment completion

• The proportion of study patients clinically free of clinically significant PCa (i.e. requires definitive treatment)

  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.

  24 months after treatment completion

Secondary Outcomes (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

  Baseline before treatment, 30 days, 6 months, 12 months and at 24 months following treatment

• 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

  Baseline before treatment, 30 days, 6 months, 12 months and at 24 months following treatment

Study Arms (1)

Single arm prospective clinical trial

EXPERIMENTAL

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

Interventions

The TRANBERGCLS|Thermal Therapy DEVICE

MRI Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS\|Thermal Therapy

Single arm prospective clinical trial

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Men with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<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.

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, 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 noncompliance 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Clinical Laserthermia Systems AB: collaborator

Study Sites (1)

Sangeet Ghai, MD

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

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 Officials

• Sangeet Ghai, MD

  Director; Biopsy Centre, Abdominal Division and Joint Department of Medical Imaging

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangeet Ghai, MD

CONTACT

416-340-4800; sangeet.ghai@uhn.ca

Kateri Corr, RPN

CONTACT

416-946-4501; kateri.corr@uhn.ca

Study Design

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

Model Details: 24 Month, Prospective, Interventional, Open-label Single-Arm Effectiveness Study

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 28, 2018
• Study Start: March 29, 2018
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)