MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer

Localized Prostate Cancer Clinical Trial

— MRI-TULSAP  

Official title:

Evaluation of an Alternative Treatment of Localized Prostate Cancer by Guided MRI Transurtral Ultrasound With 1-year Control of the Absence of Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03996005
• Other study ID #: 7429
• Status: Completed
• Phase: N/A
• Start date: September 24, 2019
• Est. completion date: July 25, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary purpose : Evaluation of the efficiency and safety of an alternative global prostate treatment in localized prostate cancer. Primary Objective: Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up. Secondary Objectives: 1. Biochemical response 2. Presence of any CSC on biopsy at 1- and 2-year follow-up 3. Radical treatment free survival 4. Adverse events, clinical tolerance 5. Urinary continence 6. Erectile function 7. Quality of life

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• Male patient = 50 years old
• Histologically confirmed adenocarcinoma of the prostate
• Gleason = 7 (3 + 4) ; Grade group = 2 according to Epstein
• Clinically <T3, N0, M0
• PSA < 15 ng/mL
• Prostate volume <100g
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Life expectancy higher than 12 months in the judgement of the investigator
• Radiological TNM (prostate MRI) T = 2 (absence of extra-capsular extension, absence of seminal vesicle invasion), N = 0, M = 0
• First line of treatment or relapse after initial radiotherapy
• Willing to give signed, informed consent freely
• Able to adhere to the follow-up schedule and other protocol requirements.

Exclusion Criteria:

• Contraindication to MRI
• Contraindication to general anesthesia
• Presence or history of any other malignancy except for non-melanoma skin cancer adequately treated at least 2 years before study entry
• Unreversible haemostasis disorder

Related Conditions & MeSH terms

• Ablation Therapy
• Localized Prostate Cancer
• MRI Guided Transurethral Ultrasound Ablation
• Prostatic Neoplasms

Intervention

Procedure:
• Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up.	Clinically significant cancer (CSC) defined by at least one of the following criteria: Gleason score = 7; cancer core length > 3 mm regardless of Gleason score; > 2 positive cores.	1 year
Secondary	Biochemical response	PSA	Month 3
Secondary	Biochemical response	PSA	Month 6
Secondary	Biochemical response	PSA	Month 12
Secondary	Presence of any CSC on biopsy at 1-year follow-up	Pathology analysis of the biopsy	at 1-year follow-up
Secondary	Radical treatment free survival	Evaluation of the complication according to Dindo-Clavien	at 1-year follow-up
Secondary	Adverse events, clinical tolerance		at 1-year follow-up
Secondary	Urinary continence	Urinary continence evaluation by using the USP scale	Month 3
Secondary	Urinary continence	Urinary continence evaluation by using the USP scale	Month 6
Secondary	Urinary continence	Urinary continence evaluation by using the USP scale	Month 12
Secondary	Erectile function	Erectile function evaluated by using the IIEF15 scale	Month 3
Secondary	Erectile function	Erectile function evaluated by using the IIEF15 scale	Month 6
Secondary	Erectile function	Erectile function evaluated by using the IIEF15 scale	Month 12
Secondary	Quality of life EORTC QLQ-C30 scale.	EORTC QLQ-C30 scale.	Month 3
Secondary	Quality of life EORTC QLQ-C30 scale.	EORTC QLQ-C30 scale.	Month 6
Secondary	Quality of life EORTC QLQ-C30 scale.	EORTC QLQ-C30 scale.	Month 12