Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer

EDAP TMS

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Prostate Cancer

Treatments

Device: Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)

Device: Integrated Imaging High Intensity Focused Ultrasound

Study type

Interventional

Funder types

Industry

Identifiers

NCT00295802

G050103

Details and patient eligibility

About

The purpose of this study is to determine the substantial equivalence of the Ablatherm high intensity focused ultrasound (HIFU) as compared to cryotherapy for the treatment of low risk, localized prostate cancer.

Full description

Primary hypothesis of this clinical investigation is that HIFU with the Ablatherm Integrated Imaging is non-inferior to minimally invasive cryosurgery as an effective treatment method for low risk, localized prostate cancer.

Enrollment

141 patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of prostate cancer confirmed by PSA and prostate biopsy
Male subjects, aged equal to or over 50 years
Organ-confined prostate cancer, clinical stage T1a, b, or c or T2a
At least one positive biopsy within the previous 6 months
PSA equal to or less than 10 ng/ml
Gleason score equal to or less than 6
Histological grading of 3+3, 3+2, 2+3, 2+4, or 2+2 based upon the baseline transrectal ultrasound (TRUS)-guided 10 core biopsy results. A subject with a histological grading of primary 4 will not be permitted for study enrollment.
Prostate volume equal to or less than 40 cc
Prostate anteroposterior (AP) diameter equal to or less than 25 mm
Normal rectal anatomy and rectal mucosa
Maximum rectal wall measurement 6 mm
The Investigator has completed a medical history and a physical examination to assure that the subjects meet all study enrollment criteria
The subject is willing and able to read, understand, and sign the study specific informed consent form
The subject agrees to comply with study protocol requirements, including HIFU or cryotherapy treatment and all follow up visit requirements through 24 months of follow up treatment.

Exclusion criteria

Evidence of seminal vesicle involvement
Evidence of lymph node involvement or metastasis
Any previous treatment for prostate cancer including: external beam radiation therapy (EBRT), hormone therapy and/or previous bilateral orchiectomy
Previous surgery or procedure of the prostate (except prostate biopsy) or urethra within the prior one year
Calcification inducing a shadow in the prostate which cannot be included in the targeted volume
Large median lobe of the prostate which cannot be included in the target volume
Use within the previous 2 months of finasteride
Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease
Active inflammatory bowel syndrome
Current superficial bladder cancer, urethral stricture, or bladder neck contracture
Active urinary tract infection or prostatitis (the subject may be enrolled once the infection has been treated and has resolved)
Compromised renal function or upper urinary tract disease as a result of urinary obstruction
A history of bleeding disorders/coagulopathy or ongoing treatment for this condition
Urinary tract or rectal fistula
Rectal fibrosis, rectal stenosis, or other anomalies making the Ablatherm Integrated Imaging rectal probe insertion difficult
Anatomical anomaly of the rectum or anomaly of the rectal mucous membrane
Prostate seroma, prostate abscess, or urethral stenosis
An intraprostatic implant such as a stent or catheter, or any implant or prosthesis at less than 1 cm from the prostate
Interest in future fertility
Concurrent illness, disability, or geographical residence would hamper attendance at required study visits
Known latex hypersensitivity
Current participation in another clinical investigation of a medical device or a drug or has participated in such a study within 30 days prior to study enrollment
The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the HIFU or cryotherapy procedure and study-related follow up visit requirements.