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

Sponsor
Profound Medical Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT02766543
Collaborator
(none)
150
Enrollment
15
Locations
1
Arm
116.3
Anticipated Duration (Months)
10
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: MRI-guided Transurethral Ultrasound Ablation
N/A

Detailed Description

Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral ultrasound therapy system (TULSA-PRO). The technology is developed for patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.

The treatment is conducted within a MRI suite, which enables real-time temperature images of the heated region to be acquired as the ultrasonic treatment is delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the pattern of thermal coagulation accurately and precisely in the prostate gland.

It provides advantages of a non-invasive procedure with short treatment times.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Treatment
Official Title:
Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study
Actual Study Start Date :
Sep 21, 2016
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

ArmIntervention/Treatment
Experimental: MRI-guided Transurethral Ultrasound Ablation Device

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

Device: MRI-guided Transurethral Ultrasound Ablation
Magnetic resonance imaging-guided transurethral ultrasound ablation is a novel minimally-invasive procedure where the therapeutic endpoint is prostate ablation through thermal coagulation.
Other Names:
  • TULSA-PRO
  • Outcome Measures

    Primary Outcome Measures

    1. Safety Endpoint - Incidence of treatment-emergent adverse events [1 year]

      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).

    2. Efficacy Endpoint - Proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value. [1 year]

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

    Secondary Outcome Measures

    1. 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).]

      Rate of erectile dysfunction, determined by the change from baseline of the proportion of patients with IIEF-5 < 17.

    2. 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).]

      Rate of erection firmness sufficient for penetration, determined by the change from baseline of the proportion of patients with IIEF item 2 ≥ 2.

    3. 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).]

      Rate of urinary incontinence, determined by the change from baseline of the proportion of patients with EPIC item 5 ≥ 1 (one or more pads per day).

    4. PSA Nadir Endpoint [1 year]

      Proportion of patients achieving PSA nadir ≤ 0.5 ng/ml.

    5. 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).]

      Proportion of patients with PSA ≤ 0.5 ng/ml at the most recent follow-up visit.

    6. Prostate Volume Endpoint [1 year]

      Prostate volume reduction, evaluated on MRI between the treatment day and 12-month follow-up visits.

    7. Prostate Biopsy Endpoint [1 year]

      Proportion of patients with negative prostate biopsy at the 12-month follow-up visit, determined by transrectal ultrasound-guided 10-core biopsy.

    8. IPSS 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).]

      Change in International Prostate Symptom Score (IPSS), between the baseline and most recent follow-up visit.

    9. IIEF 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).]

      Change in the Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Satisfaction domains of the International Index of Erectile Function (IIEF-15), between the baseline and most recent follow-up visit.

    10. EPIC 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).]

      Change in Urinary, Bowel, Sexual and Hormonal domains of the Expanded Prostate Cancer Index Composite (EPIC), between the baseline and most recent follow-up visit.

    11. Targeting Accuracy Endpoint [During treatment]

      Conformal prostate ablation, measured quantitatively between the target prostate volume and the target temperature isotherm on MRI thermometry acquired during the TULSA-PRO procedure, and described using three measures of targeting accuracy (Dice Similarity Coefficient; Over- and under-targeted volumes; Linear targeting in mm).

    12. CE-MRI Endpoint [Immediately after treatment]

      Conformal prostate ablation, assessed qualitatively by visualizing the peripheral region of enhancement surrounding the non-perfused volume (NPV) on contrast-enhanced (CE)-MRI acquired immediately after treatment.

    13. mpMRI Endpoint [1 year]

      Characterize the effect of the TULSA-PRO ablation on diagnostic multi-parametric prostate MRI (mpMRI), determined using PI-RADS v2 performed at the Baseline and 12-month follow-up visits.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Male, age 45 to 80 years

    2. 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).

    3. Clinical stage ≤ T2b

    4.1 Gleason score ≤ 3 + 4 (Part I only)

    4.2 Gleason score 3+4 (Part II only) *now recruiting

    1. PSA ≤ 15 ng/ml

    2. Eligible for MRI [Form GCP-10131]

    3. Eligible for general anesthesia (ASA category ≤ 3)

    4. Prostate volume ≤ 90 cc, on Baseline MRI

    5. Prostate size ≤ 5.0 cm in sagittal length, and ≤ 6.0 cm in axial diameter, on Baseline MRI

    6. Life expectancy ≥ 10 years

    7. No calcifications in the planned ultrasound beam path, or at the discretion of the investigator with approval from the Sponsor.

    Exclusion Criteria:
    1. Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases

    2. Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane

    3. Prior definitive treatment of prostate cancer

    4. Prior transurethral resection of the prostate (TURP)

    5. 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.

    6. Prostate calcifications > 1 cm in largest diameter, on Baseline Ultrasound

    7. Cysts > 1 cm in largest diameter, on Baseline MRI

    8. Bleeding disorder (INR > ULN and PTT > ULN)

    9. Abnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not exclusion criteria.

    10. Acute unresolved Urinary Tract Infection (UTI)

    11. Interest in future fertility

    12. 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.

    13. Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome

    14. Patients with diabetes who have evidence of complications from their diabetes, such as end organ sequelae of diabetes or Hemoglobin A1c > 7%.

    15. History of any major rectal or pelvic surgery or radiotherapy

    16. History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (includes rectal fistula, anal stenosis)

    17. Documented clinical prostatitis requiring therapy within 6 months prior to Treatment

    18. History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae, urethral stenting, urethral sling, urethroplasty or chronic indwelling urethral catheter

    19. Patients with artificial urinary sphincter or any penile implant

    20. Severe neurogenic bladder

    21. Untreated bladder stones

    22. History of acute urinary retention within the last 12 months

    23. Active untreated gross hematuria for any cause

    24. Post Void Residual (PVR) bladder volume > 250 mL

    25. Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder, sometimes referred to as "ball valve" median lobe, determined on Baseline MRI

    26. Any prostate related investigational therapy within 6 months of Visit 1

    27. History of Parkinson's disease or multiple sclerosis

    28. History of drug abuse

    29. Known infectious disease including HIV positivity or AIDS-related illness, HBV and HCV

    30. Current unilateral or bilateral hydronephrosis

    31. Allergy or contraindications to administration of the GI anti-spasmodic drug:

    32. Patients in the USA: Glucagon

    33. Patients in Canada and Europe: Buscopan (Hyoscine)

    34. Contraindications to administration of gadolinium-based MRI contrast agent (e.g. Magnevist), such as chronic, severe kidney disease, acute kidney injury, history of Sickle Cell Disease, history of anemia, or intolerance/allergy to the contrast agent

    35. Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of California Los AngelesLos AngelesCaliforniaUnited States90095
    2Yale Cancer CentreNew HavenConnecticutUnited States06520-8058
    3University of ChicagoChicagoIllinoisUnited States60637
    4Indiana UniversityIndianapolisIndianaUnited States46202
    5Johns Hopkins MedicineBaltimoreMarylandUnited States21231
    6William Beaumont HospitalRoyal OakMichiganUnited States48073
    7Vanderbilt University Medical CenterNashvilleTennesseeUnited States37232
    8University of Texas Southwestern Medical CenterDallasTexasUnited States75390-9105
    9London Health Sciences CentreLondonOntarioCanadaN6C 2R5
    10Sunnybrook Health Sciences CentreTorontoOntarioCanadaM4N 3M5
    11University Hospital of CologneCologneGermany50937
    12Universitätsklinikum Heidelberg (University of Heidelberg, Dept of Urology)HeidelbergGermany69120
    13Radboud University Medical CenterNijmegenNetherlands6500
    14Clinica Universidad de NavarraPamplonaNavarraSpain31008
    15ResoFus Alomar (Hospital Universitari De Bellvitge)BarcelonaSpain08029

    Sponsors and Collaborators

    • Profound Medical Inc.

    Investigators

    • Principal Investigator: Scott Eggener, MD, University of Chicago

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Profound Medical Inc.
    ClinicalTrials.gov Identifier:
    NCT02766543
    Other Study ID Numbers:
    • GCP-10100
    First Posted:
    May 9, 2016
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Profound Medical Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021