Evaluation of an Alternative Treatment of Localized Prostate Cancer by Guided MRI Transurtral Ultrasound With 1-year Control of the Absence of Cancer
Phase: NA
Conditions: MRI Guided Transurethral Ultrasound Ablation, Localized Prostate Cancer, Ablation Therapy
Sponsor: University Hospital, Strasbourg, France

Direction de la Recherche Clinique et des Innovations  
PRI 2019 - HUS N° 7429 
 
 
V3.1 du 20/10/2020 approuvée par le CPP Sud Méditerranée IV  le 09/11/2021 
1/4 
 
 
STUDY SUMMARY 
RESEARCH TITLE:  
Evaluation of an alternative treatment for localized prostate cancer using MRI-guided transurethral 
ultrasound with 1-year control for absence of cancer. 
Abbreviated Title : MRI-TULSA 
Sponsor : Hôpitaux Universitaires de Strasbourg 
Principal Investigator: Dr Thibault TRICARD 
N° HUS : 7429 
N° IDRCB: 2019-A01537-50 
Research justification:   
Evaluation of a comprehensive alternative prostate treatment for the management of localized 
prostate cancer. 
Primary objective: 
Demonstrate that mri-guided transurethral ultrasound (mri-tulsa) enables disease control with 
absence of clinically significant cancer at the 1-year control biopsy. 
Secondary objectives: 
1. Evaluate biological response (psa) after treatment. 
2. Verify absence of any cancer at 1-year control biopsies. 
3. Calculate survival without radical salvage treatment (surgery, radiotherapy, or cryotherapy). 
4. Evaluate side effects, complications, and hospitalizations related to device use. 
5. Assess satisfactory clinical tolerance post-treatment (urinary functional symptoms, urinary 
continence, erectile dysfunction, quality of life). 
Primary evaluation criterion 
Absence of clinically significant cancer at 1-year prostate biopsy. 
Clinically significant cancer defined by: 
- 
Gleason ≥ 7, or 
- 
3 mm cumulative positive biopsy regardless of gleason score, or 
- 
2 positive biopsies 
Critères d’évaluation secondaires : 
1. Psa variation between pre- and post-operative periods. 
2. Presence of non-clinically and clinically significant cancer at 1-year control biopsies. 
3. Absence of salvage treatment. 
4. Presence of complications requiring hospitalization. 
5. Assessment of functional impact and quality of life: 
a. Urinary continence (usp) 
b. Erectile function (iief-15 ≤16) 
c. Quality of life (eortc qlq-c30) 
d. Ipss score 
Experimental plan 
Prospective, monocentric, interventional study on patients. 
Inclusion criteria :  
- Male ≥50 years, no upper age limit 

Direction de la Recherche Clinique et des Innovations  
PRI 2019 - HUS N° 7429 
 
 
V3.1 du 20/10/2020 approuvée par le CPP Sud Méditerranée IV  le 09/11/2021 
2/4 
 
- Histological proof of prostate adenocarcinoma 
- Gleason ≤ 7(3+4) 
- <t3 clinical, n0, m0 
- Psa <15 ng/ml 
- Prostate volume < 90 cc 
- Ecog performance status 0-1 
- Radiological tnm t≤ 2, n0, m0 
- First-line treatment or relapse after primary radiotherapy 
- Subject affiliated with a social security health insurance regime 
- Subject able to understand study objectives and risks and provide informed consent 
- Subject informed of pre-study medical visit results 
Non-inclusion criteria 
 
Prostate gland size exceeding 5 cm length and 6 cm axial diameter on reference mri 
 
Prostate tissue containing cysts and/or calcifications > 1 cm (calcifications or cysts < 1 cm 
tolerated if not located near the periphery where temperature control occurs) 
 
Contraindication to mri (e.g., electrical or metallic implants, metallic fragments in body) 
 
Contraindication to gadolinium contrast (hypersensitivity to gadoteric acid, meglumine, or 
gadolinium-containing drugs) 
 
Contraindication to general anesthesia 
 
Metastatic cancer on imaging 
 
History of other cancer except non-melanoma tumor effectively treated 2 years prior to 
inclusion 
 
Irreversible hemostasis disorders 
 
Inability to provide informed information (emergency situation, comprehension difficulties) 
 
Urinary infection on ecbu 10 days before procedure not effectively treated at least 48 hours 
prior 
 
Subject under judicial protection 
 
Subject under guardianship or curatorship 
 
Subject in exclusion period from previous or ongoing study 
Trial procedure 
Information visit: consultation in urology surgery department for histologically confirmed localized 
prostate cancer. Patient informed about study. Pelvic mri and bone scintigraphy performed prior to 
inclusion in study. 
Inclusion visit: informed consent and pre-therapeutic clinical evaluation (usp, ipss, iief-15, eortc qlq-
c30). 
Anesthesia consultation: approximately 3 weeks before surgery. 
Hospitalization: 2-3 days for comprehensive prostate treatment. 

Direction de la Recherche Clinique et des Innovations  
PRI 2019 - HUS N° 7429 
 
 
V3.1 du 20/10/2020 approuvée par le CPP Sud Méditerranée IV  le 09/11/2021 
3/4 
 
Follow-up consultations: clinical and biological follow-up at 15 days, 3 months, 6 months, and 12 
months with control mri at 3, 6, and 12 months. 
End-of-study visit: 1 year post-treatment with systematic prostate biopsy at 12 months post-
treatment and/or if suspicious lesion on mri or psa > nadir+2 ng/ml. 
Experimental drug 
Not applicable. 
Medical device (non-experimental) 
Tulsa-pro® is a medical device marketed by profound medical inc., toronto, canada, which obtained 
its ce (european conformity) marking in january 2018. 
This device combines mri imaging with focused transurethral ultrasound treatment of the prostate. 
Authorized and/or prohibited treatments 
Authorized treatments: 
 
Usual analgesics levels I to III 
 
Antiepileptics or antidepressants with marketing authorization for neuropathic pain 
 
Capsaicin patch for local application 
 
Gadoteric acid 
 
Non-adrenaline lidocaine 
 
Treatments administered for general anesthesia and during post-operative period 
 
Systematic antibiotic prophylaxis: cefazoline, cefuroxine, gentamicin 
Prohibited treatments: 
 
Anticoagulant treatments constitute a relative contraindication and must be relayed by 
heparin treatment to allow a therapeutic window (during biopsies and during the therapeutic 
procedure) 
 
Radiological procedure, radiotherapy, or prostate cryotherapy during the study period 
Antiplatelet agent is not a contraindication; in case of dual  Antiplatelet aggregation , a period of 5-10 
days of monotherapy should be recommended 
Number of subjects required : 25 
Statistical method 
Statistical analyses will include a descriptive phase and an inferential phase using fully bayesian 
techniques. 
All analyses will be performed using r software. 
In the absence of statistical testing, there is no type i error rate to set. Credibility intervals will be 
symmetric intervals at the 5% level. 

Direction de la Recherche Clinique et des Innovations  
PRI 2019 - HUS N° 7429 
 
 
V3.1 du 20/10/2020 approuvée par le CPP Sud Méditerranée IV  le 09/11/2021 
4/4 
 
 
 
Survival analysis without radical salvage treatment will be performed using the kaplan-meier 
technique. 
Provisional timeline 
Inclusion period duration: 36 months 
Individual subject participation duration: 12 months 
Total study duration: 48 months 
Exclusion duration: 
 
During the study: 12 months 
 
At the end of the study: not applicable 
 
In case of premature exit: not applicable