Clinical trial NCT03996005: MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MRI Guided Transurethral Ultrasound Ablation
Localized Prostate Cancer
Ablation Therapy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 25
Sex: MALE
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up.
timeFrame: 1 year
Secondary outcomes:
measure: Biochemical response
timeFrame: Month 3
measure: Biochemical response
timeFrame: Month 6
measure: Biochemical response
timeFrame: Month 12
measure: Presence of any CSC on biopsy at 1-year follow-up
timeFrame: at 1-year follow-up
measure: Radical treatment free survival
timeFrame: at 1-year follow-up
measure: Adverse events, clinical tolerance
timeFrame: at 1-year follow-up
measure: Urinary continence
timeFrame: Month 3
measure: Urinary continence
timeFrame: Month 6
measure: Urinary continence
timeFrame: Month 12
measure: Erectile function
timeFrame: Month 3
measure: Erectile function
timeFrame: Month 6
measure: Erectile function
timeFrame: Month 12
measure: Quality of life EORTC QLQ-C30 scale.
timeFrame: Month 3
measure: Quality of life EORTC QLQ-C30 scale.
timeFrame: Month 6
measure: Quality of life EORTC QLQ-C30 scale.
timeFrame: Month 12
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de strasbourg
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Thibault TRICARD, MD
role: PRINCIPAL_INVESTIGATOR
References: