Dynamic Focusing Evaluation for Prostate Cancer Treatment

Cancer of Prostate Clinical Trial

— FOC/DYN  

Official title:

Evaluation of a Dynamic Focusing Ultrasonic Transducer for High Intensity Focused Ultrasound (HIFU) Treatment of Localized Prostate Adenocarcinoma - Dose Escalation Trial to Define the Best Acoustic Parameters

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03632980
• Other study ID #: HIFU/F/10.08
• Secondary ID: 2011-A00313-38
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2011
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: EDAP TMS S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Define the best acoustic parameters for the dynamic focusing HIFU transducer in the treatment of localized Prostate Cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 70 Years and older

Eligibility

Inclusion Criteria for primary care patients:

• Age > 70 years

• T1 or T2

• PSA < 15 ng/mL

• 12 randomized biopsies

• Gleason score = 3+4

• Normal anal and rectal anatomy

• American Society of Anesthesiologists risk (ASA) 1 or 2

Exclusion Criteria for primary care patients:

• T3 patients

• American Society of Anesthesiologists risk (ASA) 3

• Metastatic disease (Bone scan…)

• Previous prostate cancer therapy

• Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness

• Prostate volume over 50cc

• Previous bladder cancer

• contraindication to MRI

• previous rectal or urinary fistulae

Inclusion Criteria for salvage patients:

• Age > 50 years

• T1 or T2

• Biochemical recurrence after radiotherapy (Phoenix definition: nadir+2ng/ml)

• 12 randomized biopsies

• Normal anal and rectal anatomy

• ASA 1 or 2

Exclusion Criteria for salvage patients:

• T3 patients

• ASA 3

• Metastatic disease (Bone scan…)

• Distance between rectal mucosa and prostatic capsule of more than 8 mm thickness

• Prostate volume over 50cc

• Previous bladder cancer

• contraindication to MRI

• previous rectal or urinary fistulae

Related Conditions & MeSH terms

• Cancer of Prostate
• Prostatic Neoplasms

Intervention

Device:
• "Ablatherm Foc/Dyn" or "Focal One" HIFU treatment
Non invasive treatment of localized prostate cancer by High Intensity Focused Ultrasound therapy, endorectal application. or Non invasive treatment of localized prostate cancer recurrency by High Intensity Focused Ultrasound therapy after radiotherapy failure, endorectal application.

Locations

Country	Name	City	State
France	Edouard Herriot Hospital	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
EDAP TMS S.A.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Necrosis measurement (immediate efficacy)	The coagulation necrosis induced by the HIFU dynamic focusing treatment of the prostate is evaluated by MRI in the first week post treatment.	Day 7
Secondary	Histological marker measurement (mid term efficacy)	The mid term efficacy is evaluated by the rate of negative biopsy at 6 months.	6 months
Secondary	Biochemical marker measurement (mid term efficacy)	The mid term efficacy is evaluated by the percentage of patient with a PSA nadir = 0.3ng/mL	6 months
Secondary	Rectal wall preservation (immediate safety and morbidity)	Evaluate the rectal wall preservation by MRI in the first week post treatment.	Day 7
Secondary	Adverse events reporting rates (safety and the morbidity) at 6 months	Adverse Events reporting	6 months
Secondary	Adverse events reporting rates (safety and the morbidity) at 24 months	Adverse Events reporting	24 months
Secondary	Quality of life score	Quality of life will be assessed using the QLQC30 (Quality of Life questionnaire) questionnaire.; It is a specific questionnaire to determine the quality of life a patient with cancer. It is composed of 30 questions with 4 potential answers going from: not at all, a little, enough or a lot, within 28 questions and with a visual scale going from 1 to 7 (7 being excellent and 1 being very bad) for the last 2 questions. The raw score is established by adding the score of each question and a linear transformation range it from 0 to 100. The higher the score, the worse the quality of life.	3 months
Secondary	Quality of life score	Quality of life will be assessed using the QLQC30 (Quality of Life questionnaire) questionnaire.; It is a specific questionnaire to determine the quality of life a patient with cancer. It is composed of 30 questions with 4 potential answers going from: not at all, a little, enough or a lot, within 28 questions and with a visual scale going from 1 to 7 (7 being excellent and 1 being very bad) for the last 2 questions. The raw score is established by adding the score of each question and a linear transformation range it from 0 to 100. The higher the score, the worse the quality of life.	6 months
Secondary	IPSS score	Urinary function will be assessed using the IPSS (International Prostate Score Symptom) questionnaire.; The IPSS questionnaire is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The score is then categorized as follow: Mild (symptoms score less than or equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35). The higher the score, the worse the symptoms.	3 months
Secondary	IPSS score	Urinary function will be assessed using the IPSS (International Prostate Score Symptom) questionnaire.; The IPSS questionnaire is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35. The score is then categorized as follow: Mild (symptoms score less than or equal to 7), Moderate (symptom score range 8-19), Severe (symptom score range 20-35). The higher the score, the worse the symptoms.	6 months
Secondary	IIEF-5 score	Sexual function will be assessed using the IIEF-5 (The International Index of Erectile Function) questionnaire.; The IIEF-5 Questionnaire is composed of 5 items with 5 possible answers rating from 1 to 5 (very low, low, moderate, high, very high).; The score is the sum of the ordinal responses to the 56 items. It is then categorized as follow: 22-25: No erectile dysfunction, 17-21: Mild erectile dysfunction, 12-16: Mild to moderate erectile dysfunction, 8-11: Moderate erectile dysfunction, 5-7: Severe erectile dysfunction. The higher the score, the better the sexual function.	3 months
Secondary	IIEF-5 score	Sexual function will be assessed using the IIEF-5 (The International Index of Erectile Function) questionnaire.; The IIEF-5 Questionnaire is composed of 5 items with 5 possible answers rating from 1 to 5 (very low, low, moderate, high, very high).; The score is the sum of the ordinal responses to the 56 items. It is then categorized as follow: 22-25: No erectile dysfunction, 17-21: Mild erectile dysfunction, 12-16: Mild to moderate erectile dysfunction, 8-11: Moderate erectile dysfunction, 5-7: Severe erectile dysfunction. The higher the score, the better the sexual function.	6 months