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Prostate CancerPhase 2/3NCT00295802

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

A Phase 2/3 study testing Integrated Imaging High Intensity Focused Ultrasound and Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy) in people with Prostate Cancer, run by EDAP TMS S.A. at 15 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Integrated Imaging High Intensity Focused Ultrasound and Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
15 sitesin 2 countries
Study dates
Apr 2006to Sep 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States14 sites

  • Chinn & Chinn Urology Associates

    Arcadia, California, 91006

  • Urolgoy Associates of North Texas

    Arlington, Texas, 76017

  • Univeristy of Colorado Hospital and Health Science Center

    Aurora, Colorado, 80010

  • Brooklyn Urology Research Group

    Brooklyn, New York, 11215

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77230

  • Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-2765

  • Sloan-Kettering Institute

    New York, New York, 10021

  • Florida Foundation for Healthcare Research Inc

    Ocala, Florida, 34474

  • Virginia Urology Center

    Richmond, Virginia, 23235

Other trials in United States

Canada1 site

  • Maple Leaf HIFU

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

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.

Read the detailed 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.

Conditions
Prostate Cancer
Being tested
Integrated Imaging High Intensity Focused Ultrasound, Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)
Keywords
Prostate Cancer, HIFU, EDAP, Low Risk, Localized Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated Imaging High Intensity Focused UltrasoundDevice

    Also called HIFU

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

    Also called Endocare CRYOcare Cryosurgical, Galil Medical CRYO-HIT Systems (cryotherapy)

    Cryotherapy

Study groups in NCT00295802
Study groupRoleWhat they receive
HIFUExperimentalIntegrated Imaging High Intensity Focused Ultrasound using the Ablatherm Device
Receives: Device: Integrated Imaging High Intensity Focused Ultrasound
CryotherapyActive comparatorEndocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)
Receives: Device: Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Attainment achievement of prostate-specific antigen (PSA) nadir < 0.5 ng/ml and stability of PSA according to American Society for Therapeutic Radiology and Oncology (ASTRO) criteria through 24 month follow up without a positive biopsy

    Measured: Through 24 month period

Secondary outcomes (5)

  1. Achievement of a nadir PSA within 6 months < 0.5 ng/ml

    Measured: 6 months

  2. Overall survival, defined as time to death due to any cause

    Measured: From date of treatment until the date of death due to any cause

  3. Disease specific survival, defined as the time to death due to the underlying disease

    Measured: "From date of treatment until the date of death due to the underlying cause

  4. Change from baseline in the University of California, Los Angeles Quality of Life (UCLA QOL)

    Measured: 1 month, 6 months, 12 months, 24 months

  5. Change from baseline in the International Prostate Symptom Score (IPSS)

    Measured: 1 month, 6 months, 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionAug 2012
  4. Study completionSep 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00295802
Sponsor's protocol ID
G050103
Status last verified
Feb 2014
First submitted
22 Feb 2006
Last updated
7 Feb 2014
Results posted
No
Data monitoring committee
No

Publications

  • Thuroff S, Chaussy C, Vallancien G, Wieland W, Kiel HJ, Le Duc A, Desgrandchamps F, De La Rosette JJ, Gelet A. High-intensity focused ultrasound and localized prostate cancer: efficacy results from the European multicentric study. J Endourol. 2003 Oct;17(8):673-7. doi: 10.1089/089277903322518699.

    PubMed 14622488

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Integrated Imaging High Intensity Focused Ultrasound and Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy) in people with Prostate Cancer, run by EDAP TMS S.A. at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Attainment achievement of prostate-specific antigen (PSA) nadir < 0.5 ng/ml and stability of PSA according to American Society for Therapeutic Radiology and Oncology (ASTRO) criteria through 24 month follow up without a positive biopsy (time frame: Through 24 month period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00295802, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2014.

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