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Focal Therapy Using HIFU for Localised Prostate Cancer
Conditions
Prostate Cancer
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
Prostate cancer, HIFU Hemi-ablation, Prostate biopsies
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: High Intensity Focused Ultrasound
Type: Procedure
Overall Status
Recruiting
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.
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 50 Years
Gender: Male
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
- 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
Location
Jewish General Hospital,Urology Department
Montreal, Quebec, Canada
Status: Recruiting
Contact: Franck Bladou, MD - 1-514-340-8222 - fbladou@jgh.mcgill.ca
Start Date
September 2013
Completion Date
September 2016
Sponsors
Jewish General Hospital
Source
Jewish General Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page