Focal Therapy Using HIFU for Localised Prostate Cancer

Trial Title: Focal Therapy Using HIFU for Localised Prostate Cancer

NCT ID: NCT02016040

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
Prostate cancer
HIFU Hemi-ablation
Prostate biopsies

Study type: Interventional

Study phase: Phase 2/Phase 3

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: High Intensity Focused Ultrasound
Arm group label: HIFU hemi-ablation

Summary: 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.

Criteria for eligibility:
Criteria:
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

Gender: Male

Minimum age: 50 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Jewish General Hospital,Urology Department

Address:
City: Montreal
Zip: H3T 1E2
Country: Canada

Start date: March 17, 2013

Completion date: November 2017

Lead sponsor:
Agency: Jewish General Hospital
Agency class: Other

Source: Jewish General Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02016040