MRI Guided Transurethral HIFU for Various Prostate Diseases

NCT03350529 | Completed

• 1 other identifier: TO3/001/17
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses feasibility and safety, the primary outcomes, of MRI guided transurethral high intensity focused ultrasound (HIFU) ablation for prostate diseases (PD). We will enrol 10 patients to each group with criteria as follows: localised prostate cancer (PC); locally advanced PC; locally recurrent PC after external beam radiation therapy (EBRT); benign prostatic hyperplasia (BPH). Secondary outcomes are both oncologic and functional outcomes and imaging based follow up after HIFU therapy will be also assessed.

Conditions

Localised Prostate Cancer; Locally Advanced Prostate Cancer; Locally Recurrent Prostate Cancer; Benign Prostatic Hyperplasia

Keywords

prostate cancer; benign prostatic hyperplasia; benign prostatic obstruction; high intensity focused ultrasound; real-time temperature feedback control; magnetic resonance imaging

Outcome Measures

Primary Outcomes (8)

• Evaluate targeting accuracy of HIFU ablation separately in each study arm/group.

  Quantitative analysis of targeting accuracy is defined as spatial difference between target prostate region in treatment planning phase and the target temperature isotherm (57°C) at the end of HIFU treatment on MRI thermometry. The measure used is dice similarity coefficient (DSC - unitless from 0 to 1) which is a statistical validation metric to measure the degree of spatial overlap between two regions. The measure is a composite outcome measure reported as single value for each arm/group.

  The date of HIFU treatment

• Evaluate targeting accuracy volume of HIFU ablation separately in each study arm/group.

  Quantitative analysis of targeting accuracy volume illustrates over- and under-treatment representing the amount of tissue ≥ target temperature 57°C outside the target volume and \< target temperature 57°C inside the target volume, respectively. Over- and under-treatment volumes are expressed as a % of the target volume. The measure is a composite outcome measure reported as single value for each arm/group.

  The date of HIFU treatment

• Radiologically determined treatment accuracy of HIFU ablation in localised PC arm/group.

  Quantitative analysis of radiologically verified treatment accuracy; determined by comparing targeting volumes on MRI during treatment planning to immediate, 1 and 3 week NPV in CE-MRI following HIFU therapy. The ratio in percentage (%) between target prostate volume (ml) and NPV (ml) will be measured.

  3-4 weeks from the treatment date

• Histopathologically determined treatment accuracy of HIFU ablation in localised PC arm/group.

  Qualitative analysis of treatment accuracy; determined by comparing both targeting volume on MRI during treatment planning and immediate, 1 and 3 weeks NPV following HIFU therapy separately to histopathologically verified coagulation necrosis volume from the removed prostate at 3 week after HIFU therapy. The ratio in percentage between target prostate volume (ml) and NPV (ml) to coagulative necrosis volume (ml) will be measured.

  3-4 weeks from the treatment date

• Radiologically determined treatment accuracy of HIFU ablation in locally advanced PC arm/group.

  Quantitative analysis of treatment accuracy; determined by comparing targeting volume on MRI during treatment planning to immediate, 1 week and 12 months NPV in CE-MRI following HIFU therapy. The ratio in percentage between target prostate volume (ml) and NPV (ml) will be measured.

  12 months from the treatment date

• Radiologically determined treatment accuracy of HIFU ablation in locally recurrent PC after EBRT arm/group.

  Quantitative analysis of treatment accuracy; determined by comparing targeting volume on MRI during treatment planning to immediate, 1 week and 12 months NPV in CE-MRI following HIFU therapy. The ratio in percentage between target prostate volume (ml) and non-perfused volume (ml) will be measured.

  12 months from the treatment date

• Radiologically determined treatment accuracy of HIFU ablation in BPH arm/group.

  Quantitative analysis of treatment accuracy; determined by comparing targeting volume on MRI during treatment planning to immediate, 1 week and 12 months NPV in CE-MRI following HIFU therapy. The ratio in percentage between target prostate volume (ml) and NPV (ml) will be measured.

  12 months from the treatment date

• Safety of MRI guided transurethral HIFU ablation in various prostate diseases

  Safety is determined in each group and all group together by evaluation of the frequency and severity of device/treatment related adverse events associated with the use of TULSA-PRO system to ablate prostate tissue. The severity of the adverse events are graded according to the Clavien-Dindo Classification of surgical complications. The measure is a composite outcome measure reported as single value for each arm/group.

  12 months from the treatment date

Secondary Outcomes (2)

• Preliminary efficacy of HIFU ablation to achieve sufficient tumour control in patients having local recurrent PC after EBRT

  12 months from the treatment date

• Image based follow up following HIFU ablation

  12 months from the treatment date

Other Outcomes (7)

• Preliminary efficacy of MRI guided transurethral HIFU ablation in locally recurrent PC after EBRT in terms of serum PSA response.

  12 months from the treatment date

• Evaluate voiding function by using uroflowmetry before and after HIFU ablation separately in each arm/group.

  12 months from the treatment date

• Evaluate voiding function by measuring PVR before and after HIFU ablation separately in each arm/group.

  12 months from the treatment date

Study Arms (4)

Localised PC prior to RP

EXPERIMENTAL

MRI guided transurethral HIFU ablation is targeted to MRI visible, biopsy proven, index lesion(s) within prostate and if possible with 5mm angular extension (imaging based healthy tissue marginal) to both sides from the tumour boundary in transverse plane and 5 mm in coronal plane. The ablative effect is aimed to reach prostate capsule by heating the control boundary (3 mm from capsule) to temperature 57 °C. The focal approach is intended to be radical as for index lesion.

Device: MRI guided transurethral HIFU ablation of prostatic tissue

Symptomatic locally advanced PC

EXPERIMENTAL

MRI guided transurethral HIFU ablation is targeted to main prostatic malignant tumour squeezing and/or invading the prostatic urethra and/or bladder neck. The approach is intended to be palliative.

Device: MRI guided transurethral HIFU ablation of prostatic tissue

Locally recurrent PC after EBRT

EXPERIMENTAL

MRI guided transurethral HIFU ablation is targeted to MRI visible, biopsy proven, local recurrent index lesion(s) within and/or surrounding prostate and if possible with 5 mm angular extension to either side from the tumour boundary in transverse plane and 5 mm in coronal plane. The approach is intended to be focal and salvage. The whole-gland HIFU ablation approach will be considered in case of extensive organ confined recurrent prostate cancer (positive biopsies for malignancy from extensive/multiple area in prostate and/or extensive/multiple lesion(s) at baseline MRI) to cover whole prostate.

Device: MRI guided transurethral HIFU ablation of prostatic tissue

Symptomatic BPH

EXPERIMENTAL

MRI guided transurethral HIFU ablation is targeted to adenomas of the prostate. The HIFU sector encompasses bilateral (anterolateral) transitional zones between bladder neck and verumontanum (colliculus seminalis).

Device: MRI guided transurethral HIFU ablation of prostatic tissue

Interventions

MRI guided transurethral HIFU ablation of prostatic tissue DEVICE

The technology is developed to ablate targeted benign and malignant prostate tissue through transurethrally inserted probe that transmit ultrasound energy under MRI guidance and control. The therapeutic endpoint of this method is thermal coagulation of prostate tissue.

Also known as: TULSA-PRO (Profound Medical Inc), Device: PAD-105

Localised PC prior to RP; Locally recurrent PC after EBRT; Symptomatic BPH; Symptomatic locally advanced PC

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Language spoken: Finnish, English or Swedish
• Mental status: Patients must be able to understand the meaning of the study
• Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff.
• Potential prostate biopsies obtained \> 6 weeks before HIFU/TULSA-PRO treatment (or at the discretion of PI)
• Eligible for MRI
• Eligible for spinal or general anesthesia (ASA 3 or less)
• Succession of urethral catheterization/Patency of prostatic urethra confirmed if needed with pre-HIFU cystoscopy
• Group 1. Localized PC prior to RP
• All localized PC patients planned for robot assisted laparoscopic prostatectomy (RALP) with normal standards of care are eligible for this study (EAU guidelines)
• MRI-visible biopsy proven PC (biopsies obtained \< 6 months before treatment)
• Group 2. Locally symptomatic locally advanced and/or metastatic prostate cancer in need of palliative surgical intervention
• gross recurrent hematuria
• bladder outlet obstruction with intractable symptoms
• urinary retention
• Group 3. Locally recurrent PC after EBRT as a salvage approach

You may not qualify if:

• Prostate calcifications \>1cm in largest diameter located in the anticipated treatment sector on baseline TRUS or MRI
• Prostate cysts \>1cm in largest diameter located in the anticipated treatment sector on baseline TRUS or MRI
• History of chronic inflammatory conditions (e.g. inflammatory bowel disease) affecting rectum (also includes rectal fistula and anal/rectal stenosis)
• Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)
• Uncontrolled serious infection
• Claustrophobia
• Hip replacement surgery or other metal in the pelvic area
• Severe kidney failure (glomerular filtration rate (GFR) \<30ml/min/1.73m2) exclude usage of gadolinium in contrast-enhanced imaging unless justifiable based on the clinical judgment of the responsible radiologist and/or urologist.
• Known allergy to gadolinium
• Known allergy or contraindication to GI anti-spasmodic drug (e.g. glucagon, buscopan)
• Inability to insert urinary catheter (i.e. urethral stricture disease)
• Patients with artificial urinary sphincter, urethral sling or any penile implant
• Any other conditions that might compromise patient safety, based on the clinical judgment of the responsible urologist

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Turku: collaborator

Study Sites (1)

Department of Urology

Turku, 20521, Finland

Location

Related Publications (48)

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  PMID: 36711157 DERIVED

• Anttinen M, Makela P, Nurminen P, Yli-Pietila E, Suomi V, Sainio T, Saunavaara J, Taimen P, Blanco Sequeiros R, Bostrom PJ. Palliative MRI-guided transurethral ultrasound ablation for symptomatic locally advanced prostate cancer. Scand J Urol. 2020 Dec;54(6):481-486. doi: 10.1080/21681805.2020.1814857. Epub 2020 Sep 8.

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• Anttinen M, Yli-Pietila E, Suomi V, Makela P, Sainio T, Saunavaara J, Eklund L, Blanco Sequeiros R, Taimen P, Bostrom PJ. Histopathological evaluation of prostate specimens after thermal ablation may be confounded by the presence of thermally-fixed cells. Int J Hyperthermia. 2019;36(1):915-925. doi: 10.1080/02656736.2019.1652773.

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MeSH Terms

Conditions

Prostatic Hyperplasia; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Peter Boström, M.D.Ph.D

  Department of Urology, VSSHP, University of Turku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This study is an early phase 1 non-randomized prospective single-institutional and four arm study to determine the applicability, feasibility and safety of MRI guided transurethral HIFU ablation of prostate separately in each pre-specified group/arm (10 patients per group). Due to the encouraging feasibility and safety results, an amendment was made to the original study protocol to increase the amount of salvage group patients and BPH group patients. With the approval of the ethics committee, the sample size of the salvage group and BPH group was increased to a total of 40 patients and 30 patients, respectively.

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: November 22, 2017
• Study Start: July 24, 2017
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)