Focal Therapy Using HIFU for Localised Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Focal Therapy Using High Intensity Focused Ultrasound (ABLATHERM®) for Localised Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02016040
• Other study ID #: #12-030
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: December 3, 2013
• Last updated: April 18, 2017
• Start date: March 17, 2013
• Est. completion date: November 2017

Study information

• Verified date: April 2017
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• High Intensity Focused Ultrasound

Locations

Country	Name	City	State
Canada	Jewish General Hospital,Urology Department	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients without cancer	MRI,Biopsy,PSA	Six months
Secondary	Immediate tolerance of hemi-ablation	Adverse events	One year
Secondary	Impact of the hemi-ablation HIFU treatment on continence, sexuality and quality of life	Questionnaires	One year
Secondary	Cost of hemi-ablation HIFU treatment		One year