Evaluation of an Alternative Treatment of Localized Prostate Cancer by Guided MRI Transurtral Ultrasound With 1-year Control of the Absence of Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Absence of Clinically Significant Cancer (CSC) on Control Biopsy at 1-year Follow-up.
Study Overview
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:
- Biochemical response
- Presence of any CSC on biopsy at 1- and 2-year follow-up
- Radical treatment free survival
- Adverse events, clinical tolerance
- Urinary continence
- Erectile function
- Quality of life
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 80 Years to — (Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MRI Guided Transurethral Ultrasound
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Intervention: Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue (Procedure)
Outcomes
Primary Outcomes
Absence of Clinically Significant Cancer (CSC) on Control Biopsy at 1-year Follow-up.
Time Frame: 1 year
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.
Secondary Outcomes
No secondary outcomes reported