Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer

NCT02766543 | Active Not Recruiting DMC

• 1 other identifier: GCP-10100
• Study Type: interventional
• Target: 150
• Locations: 5 countries
• Sites: 14

Brief Summary

A prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.

Conditions

Prostate Cancer

Keywords

prostate cancer; high intensity transurethral ultrasound ablation; MRI-guided; minimally invasive; real-time temperature feedback control; whole-gland; TULSA

Outcome Measures

Primary Outcomes (2)

• Safety Endpoint - Incidence of treatment-emergent adverse events

  Frequency and severity of all adverse events will be evaluated by attribution and reported in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard published by the National Cancer Institute (NCI).

  1 year

• Efficacy Endpoint - Proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.

  Prostate ablation efficacy will be evaluated using the proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.

  1 year

Secondary Outcomes (13)

• Erectile Dysfunction Endpoint

  At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).

• Erection Firmness Endpoint

  At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).

• Urinary Incontinence Endpoint

  At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).

• PSA Nadir Endpoint

  1 year

• PSA Stability Endpoint

  At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).

Study Arms (1)

MRI-guided Transurethral Ultrasound Ablation Device

EXPERIMENTAL

Magnetic resonance imaging-guided transurethral ultrasound ablation of whole-gland prostate tissue.

Device: MRI-guided Transurethral Ultrasound Ablation

Interventions

MRI-guided Transurethral Ultrasound Ablation DEVICE

Magnetic resonance imaging-guided transurethral ultrasound ablation is a novel minimally-invasive procedure where the therapeutic endpoint is prostate ablation through thermal coagulation.

Also known as: TULSA-PRO

MRI-guided Transurethral Ultrasound Ablation Device

Eligibility Criteria

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

You may qualify if:

• Male, age 45 to 80 years
• Biopsy-confirmed adenocarcinoma of the prostate. Biopsy (minimum 10 cores) obtained ≥ 6 weeks and ≤ 6 months before treatment (or at the discretion of PI and approval by the Sponsor).
• Clinical stage ≤ T2b
• Gleason score ≤ 3 + 4 (Part I only)
• Gleason score 3+4 (Part II only) \*now recruiting
• \. PSA ≤ 15 ng/ml
• \. Eligible for MRI \[Form GCP-10131\]
• \. Eligible for general anesthesia (ASA category ≤ 3)
• \. Prostate volume ≤ 90 cc, on Baseline MRI
• \. Prostate size ≤ 5.0 cm in sagittal length, and ≤ 6.0 cm in axial diameter, on Baseline MRI
• \. Life expectancy ≥ 10 years
• \. No calcifications in the planned ultrasound beam path, or at the discretion of the investigator with approval from the Sponsor.

You may not qualify if:

• Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases
• Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane
• Prior definitive treatment of prostate cancer
• Prior transurethral resection of the prostate (TURP)
• Use of 5-alpha reductase inhibitors (5-ARIs) or hormone therapy within 3 months prior to the baseline visit. Baseline PSA must be established after a minimum of 3 months following 5-ARIs discontinuation. Additionally, use of 5-ARIs is not permitted following treatment during the study follow-up period.
• Prostate calcifications \> 1 cm in largest diameter, on Baseline Ultrasound
• Cysts \> 1 cm in largest diameter, on Baseline MRI
• Bleeding disorder (INR \> ULN and PTT \> ULN)
• Acute unresolved Urinary Tract Infection (UTI)
• Interest in future fertility
• History of any other malignancy other than skin cancer, or low grade bladder cancer which has been completely resected, within the previous 2 years. Patients that have had curative treatment of a previous malignancy and no recurrence of that malignancy within the past 2 years will be allowed.
• Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome
• Patients with diabetes who have evidence of complications from their diabetes, such as end organ sequelae of diabetes or Hemoglobin A1c \> 7%.
• History of any major rectal or pelvic surgery or radiotherapy
• History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (includes rectal fistula, anal stenosis)

Sponsors & Collaborators

• Profound Medical Inc.: lead

Study Sites (14)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Yale Cancer Centre

New Haven, Connecticut, 06520-8058, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins Medicine

Baltimore, Maryland, 21231, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9105, United States

Location

London Health Sciences Centre

London, Ontario, N6C 2R5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Hospital of Cologne

Cologne, 50937, Germany

Location

Universitätsklinikum Heidelberg (University of Heidelberg, Dept of Urology)

Heidelberg, 69120, Germany

Location

Radboud University Medical Center

Nijmegen, 6500, Netherlands

Location

ResoFus Alomar (Hospital Universitari De Bellvitge)

Barcelona, 08029, Spain

Location

Related Publications (1)

• Wright C, Makela P, Bigot A, Anttinen M, Bostrom PJ, Blanco Sequeiros R. Deep learning prediction of non-perfused volume without contrast agents during prostate ablation therapy. Biomed Eng Lett. 2022 Nov 8;13(1):31-40. doi: 10.1007/s13534-022-00250-y. eCollection 2023 Feb.

  PMID: 36711157 DERIVED

Related Links

• FDA 510k Summary

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

• Scott Eggener, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 9, 2016
• Study Start: September 21, 2016
• Primary Completion: February 28, 2019
• Study Completion (Estimated): September 30, 2028
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8); CA (2); DE (2); NL (1); ES (1)