MRI Guided Transurethral HIFU for Various Prostate Diseases
NCT ID: NCT03350529
Last Updated: 2024-11-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
87 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-07-24
Study Completion Date
2024-05-31
Brief Summary
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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.
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Detailed Description
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Prostate cancer (PC) is the most common cancer among men in Finland with the highest incidence of all cancers. Benign prostate hyperplasia (BPH) also has high prevalence, increasing with age. BPH may cause harmful lower urinary tract symptoms (LUTS) and it is demonstrated that by the age of 60, over 50 % of men have clinically significant prostate BPH and up to 40 % of men over age 60 suffer from LUTS.
Currently curative intended therapies for PC, radiation therapy (RT) and radical prostatectomy (RP), offer desirable oncologic local control but have major impact on genitourinary function and quality of life (QoL). Some patients are unfit for surgical procedures or cannot tolerate RT due to concomitant medical conditions or prior therapies. At present lower risk PC is increasingly managed with active surveillance. However, diagnosis of PC and active surveillance itself may both lead to notable psychological and emotional burden impairing QoL. Further, significant amount of cases in some point end up in radical treatment resulted from either risk profile upgrade or patients preference. For these patients optimal treatment might be a focal therapy with sufficient oncologic control and minor impact on QoL.
There is controversy related to optimal treatment in local recurrence after RT. 45% of patients will have local recurrence after RT within 8 years after treatment. Androgen deprivation therapy (ADT) decelerate disease only temporarily and salvage RP includes major risks and is technically demanding, but can provide long-term cure in selected patients.
On the aspect of palliation, there is an eminent need for less invasive supplementary therapies since patients presenting with metastatic or locally advanced PC, generally have low performance status.
Management of benign prostatic obstruction has also faced challenges with conventional treatment modalities, since ageing and profuse co-morbidities among patients have increased. Transurethral resection of prostate (TURP) is still the standard treatment in severe LUTS caused by BPH.
Recently the major development of magnetic resonance imaging (MRI) has been achieved improving PC diagnosis and local staging. Even though PC is often multifocal, evidence indicates that both clinical outcome and prognosis of PC is determined predominantly by index lesion. Because of the notable risk of morbidities involving radical treatments and significant evolution of MRI, focal therapies have attained wide interest. One of the most interesting focal mini-invasive treatment is high intensity focused ultrasound (HIFU). HIFU technique exploits thermal energy; by raising target temperature over 55°C target volume is destroyed due to acute coagulation necrosis. Modern devices delivering HIFU to the prostate are transurethral and emit directional high intensity ultrasound to the focused regions utilising superior MRI guidance compared to older generation ultrasound guidance. Magnetic resonance thermometry technique utilizes noninvasive measurement of tissue temperature allowing monitoring real time temperature changes during treatment. The MRI treatment system is equipped with active dynamic temperature feedback control designed to maintain a constant temperature inside the target volume and at the boundary of the target area. By this way conformal three-dimensional ablative volumes with great spatial accuracy and precision can be achieved simultaneously avoiding damages to the surrounding sensitive tissues. Therapy verification is confirmed instantaneously after treatment by acquiring contrast enhanced MRI (CE-MRI) that visualise the non-perfused-volume (NPV) describing the success of total ablation of the target prostate volume.
This prospective clinical single center feasibility and safety study will evaluate the role of MRI guided transurethral HIFU ablation for various PD and clinical settings. All enrolled patients have prostate pathology and different clinical situation with need of definitive interventions and they are divided to four arms/groups according to specific inclusion criterion. Group 1 localised PC prior to RP, group 2 symptomatic locally advanced PC in need of palliative surgical intervention, group 3 locally recurrent PC after EBRT and group 4 symptomatic BPH in need for intervention.
The hypothesis is that MRI guided transurethral HIFU is feasible and safe in various prostate diseases and clinical settings. If hypothesis is proven for certain or for all groups, the investigators will continue with that group or groups to phase 2 clinical multi-institutional studies.
Currently curative intended therapies for PC, radiation therapy (RT) and radical prostatectomy (RP), offer desirable oncologic local control but have major impact on genitourinary function and quality of life (QoL). Some patients are unfit for surgical procedures or cannot tolerate RT due to concomitant medical conditions or prior therapies. At present lower risk PC is increasingly managed with active surveillance. However, diagnosis of PC and active surveillance itself may both lead to notable psychological and emotional burden impairing QoL. Further, significant amount of cases in some point end up in radical treatment resulted from either risk profile upgrade or patients preference. For these patients optimal treatment might be a focal therapy with sufficient oncologic control and minor impact on QoL.
There is controversy related to optimal treatment in local recurrence after RT. 45% of patients will have local recurrence after RT within 8 years after treatment. Androgen deprivation therapy (ADT) decelerate disease only temporarily and salvage RP includes major risks and is technically demanding, but can provide long-term cure in selected patients.
On the aspect of palliation, there is an eminent need for less invasive supplementary therapies since patients presenting with metastatic or locally advanced PC, generally have low performance status.
Management of benign prostatic obstruction has also faced challenges with conventional treatment modalities, since ageing and profuse co-morbidities among patients have increased. Transurethral resection of prostate (TURP) is still the standard treatment in severe LUTS caused by BPH.
Recently the major development of magnetic resonance imaging (MRI) has been achieved improving PC diagnosis and local staging. Even though PC is often multifocal, evidence indicates that both clinical outcome and prognosis of PC is determined predominantly by index lesion. Because of the notable risk of morbidities involving radical treatments and significant evolution of MRI, focal therapies have attained wide interest. One of the most interesting focal mini-invasive treatment is high intensity focused ultrasound (HIFU). HIFU technique exploits thermal energy; by raising target temperature over 55°C target volume is destroyed due to acute coagulation necrosis. Modern devices delivering HIFU to the prostate are transurethral and emit directional high intensity ultrasound to the focused regions utilising superior MRI guidance compared to older generation ultrasound guidance. Magnetic resonance thermometry technique utilizes noninvasive measurement of tissue temperature allowing monitoring real time temperature changes during treatment. The MRI treatment system is equipped with active dynamic temperature feedback control designed to maintain a constant temperature inside the target volume and at the boundary of the target area. By this way conformal three-dimensional ablative volumes with great spatial accuracy and precision can be achieved simultaneously avoiding damages to the surrounding sensitive tissues. Therapy verification is confirmed instantaneously after treatment by acquiring contrast enhanced MRI (CE-MRI) that visualise the non-perfused-volume (NPV) describing the success of total ablation of the target prostate volume.
This prospective clinical single center feasibility and safety study will evaluate the role of MRI guided transurethral HIFU ablation for various PD and clinical settings. All enrolled patients have prostate pathology and different clinical situation with need of definitive interventions and they are divided to four arms/groups according to specific inclusion criterion. Group 1 localised PC prior to RP, group 2 symptomatic locally advanced PC in need of palliative surgical intervention, group 3 locally recurrent PC after EBRT and group 4 symptomatic BPH in need for intervention.
The hypothesis is that MRI guided transurethral HIFU is feasible and safe in various prostate diseases and clinical settings. If hypothesis is proven for certain or for all groups, the investigators will continue with that group or groups to phase 2 clinical multi-institutional studies.
Conditions
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Localised Prostate Cancer
Locally Advanced Prostate Cancer
Locally Recurrent Prostate Cancer
Benign Prostatic Hyperplasia
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
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.
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.
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Localised PC prior to RP
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.
Group Type
EXPERIMENTAL
MRI guided transurethral HIFU ablation of prostatic tissue
Intervention Type
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.
Symptomatic locally advanced PC
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.
Group Type
EXPERIMENTAL
MRI guided transurethral HIFU ablation of prostatic tissue
Intervention Type
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.
Locally recurrent PC after EBRT
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.
Group Type
EXPERIMENTAL
MRI guided transurethral HIFU ablation of prostatic tissue
Intervention Type
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.
Symptomatic BPH
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).
Group Type
EXPERIMENTAL
MRI guided transurethral HIFU ablation of prostatic tissue
Intervention Type
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.
Interventions
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MRI guided transurethral HIFU ablation of prostatic tissue
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.
Intervention Type
DEVICE
Other Intervention Names
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TULSA-PRO (Profound Medical Inc), Device: PAD-105
Eligibility Criteria
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Inclusion Criteria
* 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
* Phoenix criteria of biochemical relapse (PSA nadir + 2 ng/ml)
* MRI-visible, biopsy proven local recurrence
* No evidence of distant metastasis in PSMA-PET/CT
Group 4. Symptomatic BPH with need for intervention
* Patients planned for surgical procedure (e.g. TURP, laservaporization or open adenomectomy) with normal standards of care are eligible for this study
* Bilobular hyperplasia (enlarged transition zone lobes) without dominant enlargement of periurethral zone "median lobe" assessed in cystoscopy and TRUS
* No suspicion of cancer on baseline MRI (PI-RADS v2 lesion \< 3)
* 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
* Phoenix criteria of biochemical relapse (PSA nadir + 2 ng/ml)
* MRI-visible, biopsy proven local recurrence
* No evidence of distant metastasis in PSMA-PET/CT
Group 4. Symptomatic BPH with need for intervention
* Patients planned for surgical procedure (e.g. TURP, laservaporization or open adenomectomy) with normal standards of care are eligible for this study
* Bilobular hyperplasia (enlarged transition zone lobes) without dominant enlargement of periurethral zone "median lobe" assessed in cystoscopy and TRUS
* No suspicion of cancer on baseline MRI (PI-RADS v2 lesion \< 3)
Exclusion Criteria
* 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
* 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
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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University of Turku
OTHER
Sponsor Role
collaborator
Turku University Hospital
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Peter Boström, M.D.Ph.D
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, VSSHP, University of Turku
Locations
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Department of Urology
Turku, , Finland
Site Status
Countries
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Finland
References
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Siddiqui K, Chopra R, Vedula S, Sugar L, Haider M, Boyes A, Musquera M, Bronskill M, Klotz L. MRI-guided transurethral ultrasound therapy of the prostate gland using real-time thermal mapping: initial studies. Urology. 2010 Dec;76(6):1506-11. doi: 10.1016/j.urology.2010.04.046. Epub 2010 Aug 14.
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Partanen A, Yerram NK, Trivedi H, Dreher MR, Oila J, Hoang AN, Volkin D, Nix J, Turkbey B, Bernardo M, Haines DC, Benjamin CJ, Linehan WM, Choyke P, Wood BJ, Ehnholm GJ, Venkatesan AM, Pinto PA. Magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy of the prostate: a preclinical study with radiological and pathological correlation using customised MRI-based moulds. BJU Int. 2013 Aug;112(4):508-16. doi: 10.1111/bju.12126. Epub 2013 Jun 7.
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Burtnyk M, Hill T, Cadieux-Pitre H, Welch I. Magnetic resonance image guided transurethral ultrasound prostate ablation: a preclinical safety and feasibility study with 28-day followup. J Urol. 2015 May;193(5):1669-75. doi: 10.1016/j.juro.2014.11.089. Epub 2014 Nov 22.
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Sammet S, Partanen A, Yousuf A, Sammet CL, Ward EV, Wardrip C, Niekrasz M, Antic T, Razmaria A, Farahani K, Sokka S, Karczmar G, Oto A. Cavernosal nerve functionality evaluation after magnetic resonance imaging-guided transurethral ultrasound treatment of the prostate. World J Radiol. 2015 Dec 28;7(12):521-30. doi: 10.4329/wjr.v7.i12.521.
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Chopra R, Colquhoun A, Burtnyk M, N'djin WA, Kobelevskiy I, Boyes A, Siddiqui K, Foster H, Sugar L, Haider MA, Bronskill M, Klotz L. MR imaging-controlled transurethral ultrasound therapy for conformal treatment of prostate tissue: initial feasibility in humans. Radiology. 2012 Oct;265(1):303-13. doi: 10.1148/radiol.12112263. Epub 2012 Aug 28.
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Chin JL, Billia M, Relle J, Roethke MC, Popeneciu IV, Kuru TH, Hatiboglu G, Mueller-Wolf MB, Motsch J, Romagnoli C, Kassam Z, Harle CC, Hafron J, Nandalur KR, Chronik BA, Burtnyk M, Schlemmer HP, Pahernik S. Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue in Patients with Localized Prostate Cancer: A Prospective Phase 1 Clinical Trial. Eur Urol. 2016 Sep;70(3):447-55. doi: 10.1016/j.eururo.2015.12.029. Epub 2016 Jan 6.
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Ramsay E, Mougenot C, Kohler M, Bronskill M, Klotz L, Haider MA, Chopra R. MR thermometry in the human prostate gland at 3.0T for transurethral ultrasound therapy. J Magn Reson Imaging. 2013 Dec;38(6):1564-71. doi: 10.1002/jmri.24063. Epub 2013 Feb 25.
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Ramsay E, Mougenot C, Staruch R, Boyes A, Kazem M, Bronskill M, Foster H, Sugar L, Haider M, Klotz L, Chopra R. Evaluation of Focal Ablation of Magnetic Resonance Imaging Defined Prostate Cancer Using Magnetic Resonance Imaging Controlled Transurethral Ultrasound Therapy with Prostatectomy as the Reference Standard. J Urol. 2017 Jan;197(1):255-261. doi: 10.1016/j.juro.2016.06.100. Epub 2016 Aug 18.
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Sommer G, Pauly KB, Holbrook A, Plata J, Daniel B, Bouley D, Gill H, Prakash P, Salgaonkar V, Jones P, Diederich C. Applicators for magnetic resonance-guided ultrasonic ablation of benign prostatic hyperplasia. Invest Radiol. 2013 Jun;48(6):387-94. doi: 10.1097/RLI.0b013e31827fe91e.
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Roach M 3rd, Hanks G, Thames H Jr, Schellhammer P, Shipley WU, Sokol GH, Sandler H. Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):965-74. doi: 10.1016/j.ijrobp.2006.04.029.
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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.
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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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TO3/001/17
Identifier Type: -
Identifier Source: org_study_id
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