Ablation Therapy, Localized Prostate Cancer, MRI Guided Transurethral Ultrasound Ablation
Conditions
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
Interventions
PROCEDUREMagnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
80 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Clinically Significant Cancer (CSC) on Control Biopsy at 1-year Follow-up. | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MRI Guided Transurethral Ultrasound Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | MRI Guided Transurethral Ultrasound | — |
|---|---|---|
| Age, Continuous | 72.8 years STANDARD_DEVIATION 7 | — |
| Clinically significant cancer (CSC) on biopsy | 10 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 24 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 3 / 25 |
Outcome results
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.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI Guided Transurethral Ultrasound | Absence of Clinically Significant Cancer (CSC) on Control Biopsy at 1-year Follow-up. | 8 Participants |