Clinical trial · Interventional
Focal Therapy Using HIFU for Localised Prostate Cancer
Focal Therapy Using High Intensity Focused Ultrasound (ABLATHERM®) for Localised Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the rate of patients without cancer detected by biopsies performed six months after hemi-ablation with high intensity focused ultrasound (HIFU) (Ablatherm ®). Evaluate the impact of the HIFU treatment on continence, sexuality and quality of life at one year. Evaluate the cost of hemi-ablation HIFU treatment. A prospective single -centre phase II, single arm, cohort study (therapeutic confirmatory) offering focal therapy using HIFU (Ablatherm ®) to 25 men with histologically proven localised low to intermediate risk prostate cancer (PSA ≤10ng/ml, Gleason score ≤ 7 ,T1c or T2b ). Precise mapping and characterisation of the disease will be established using multi-parametric (mp)-MRI and prostate biopsies. Only the lobe with disease will be treated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Intensity Focused Ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- HIFU hemi-ablation
- description
- Focal Therapy Using High Intensity Focused Ultrasound (Ablatherm)
- interventionNames
- Procedure: High Intensity Focused Ultrasound
Primary outcomes (1)
- measure
- Rate of patients without cancer
- timeFrame
- Six months
- description
- MRI,Biopsy,PSA
Secondary outcomes (3)
- measure
- Immediate tolerance of hemi-ablation
- timeFrame
- One year
- description
- Adverse events
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Age≥ 50 years * Clinical stage T1c (normal digital rectal examination) or T2a (one palpable nodule on digital rectal examination) * PSA ≤10 ng / mL * Presence of cancer on biopsies (12 sampling biopsies plus 2-4 targeted biopsies on one side and limited to one or two contiguous areas of prostate: basic and middle or middle and apex). * Gleason score ≤ 7 (3+4) * Flowmetry \> 12 mL / sec for a voided volume of 125 mL * PVR \<100 mL * Patient with normal anal and rectal anatomy. * Patient with a condition corresponding to a classification of ASA 1 or 2. * Patient signing ICF and agreed for following monitoring Exclusion Criteria: * Patient with an ASA score 3. * Patient in clinical stage T1a, T1b, T2b, T2c or T3. * Patient with a tumor visible on MRI: Located at a distance less than 5 mm from the midline. Located less than 6 mm from the apex real * Metastatic lymph node or metastasis discovered by MRI and bone scan. * Patient previously treated for his prostate cancer by hormone therapy. * Patient with a distance between the rectal mucosa and prostate capsule over 8 mm thick * History of inflammatory bowel disease * Rectal fistula. * History of pelvic radiotherapy. * History of bladder cancer. * History of bladder neck sclerosis or urethral stenosis. * Patient with an implant located less than 1 cm from the treatment zone (stent, catheter). * Urogenital infection. * Latex allergy * Contraindication to MRI (pacemaker,metal prosthesis ...) * Patient participated in another clinical study within 30 days. * Illiterate patients * Legally incapable patients
References
Publications (0)
Data not yet available