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Prostate CancerPhase 3NCT00005075

Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer

A Phase 3 study testing high-intensity focused ultrasound ablation in people with Prostate Cancer, run by EDAP Technomed at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Ultrasound therapy kills tumor cells by heating them to several degrees above body temperature. This treatment may be effective for prostate cancer. PURPOSE: Phase III trial to determine the effectiveness of ultrasound therapy in treating patients who have stage I or stage II prostate cancer that has… 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?
high-intensity focused ultrasound ablation
Type of treatment
Surgery or procedure
How many people
Not given
Where
2 sitesUnited States
Study dates
Jul 1999to not given
Phase
Phase 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

DISEASE CHARACTERISTICS: Histologically proven stage I or II prostate cancer Organ confined (T1 or T2) At least 1 current positive biopsy Failed prior external beam radiotherapy for T1-T2 prostate cancer within last 18 months (with no worsening of the cancer in the first 12 months after radiotherapy) PSA nadir less than 4 ng/mL after external beam radiotherapy If prior hormonal therapy, PSA must be greater than 1.0 ng/mL and testosterone level normal after therapy Prostate volume no greater than 35 g, or 35-50 g if maximum anterior posterior diameter no greater than 2.5 cm Kattan Nomogram at least .50 60-month recurrence-free probability prior to external beam radiotherapy ASA Classification 1-3 No lymph node involvement by CT scan No metastases No prostate seroma, prostate abscess, or active prostatitis Must meet the following conditions: No artificial sphincter, penile prosthesis, or intraprostatic implant such as stent or catheter Normal rectal anatomy and rectal mucosa Rectal wall measurement no greater than 6 mm with treatment probe in place No calcification inducing a shadow in the prostate that would preclude study No significant rectal or bladder morbidity after radiotherapy (RTOG/EORTC rectal or bladder scores at least 2) No rectal fibrosis, stenosis, fistula, disease, or other rectal anomalies that would make rectal probe insertion difficult

PATIENT CHARACTERISTICS: Age: 50 and over Performance status: Not specified Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine greater than 1.8 mg/dL No prior superficial bladder cancer, urethral stricture, or bladder neck contracture No active urinary tract infection No upper urinary tract disease No compromised renal function No urinary tract fistula No urethral stenosis Other: No inflammatory bowel disease No interest in future fertility No prior HIV infection, AIDS, or other immunosuppression No known latex hypersensitivity Mentally coherent and capable of completing symptom and quality of life questionnaires No prior or concurrent illness or surgery that would preclude study or follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics At least 6 months since prior hormonal therapy Radiotherapy: See Disease Characteristics No more than 10 permanent radioactive seed implants Less than 1 cm from prostate apex or less than 1.2 cm from rectal wall Surgery: At least 6 weeks since prior transurethral resection of the prostate or other prostate surgery No prior rectal surgery except hemorrhoidectomy Other: No definitive local treatment for prostate cancer since completion of external beam radiotherapy At least 2 months since prior finasteride or other agents that affect PSA (e.g., saw palmetto) At least 3 months since prior benign prostatic hypertrophy thermotherapy or hyperthermia treatment At least 30 days since prior investigational drug or device No concurrent participation in another clinical trial

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Baylor College of Medicine

    Houston, Texas, 77030

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94143-0128

Other trials in United States

About this study

Official title: Evaluation of the Ablatherm High Intensity Focused Ultrasound Device After Failed Radiation Therapy for Localized Prostate Cancer

RATIONALE: Ultrasound therapy kills tumor cells by heating them to several degrees above body temperature. This treatment may be effective for prostate cancer.

PURPOSE: Phase III trial to determine the effectiveness of ultrasound therapy in treating patients who have stage I or stage II prostate cancer that has recurred following radiation therapy.

Read the detailed description

OBJECTIVES: I. Determine the effectiveness of the Ablatherm high-intensity focused ultrasound device in providing control of disease for at least 12 months after treatment in patients with stage I or II prostate cancer recurring after external beam radiotherapy. II. Determine the safety of this treatment device in these patients.

OUTLINE: This is an open-label, multicenter study. A probe is inserted into the rectum. Ultrasound energy is then delivered through probe to prostate tissue over 2-3 hours. Quality of life is assessed at study initiation; at 14 days and 3, 6, and 12 months; and then annually thereafter. Patients are followed at 14 days; at 3, 6, 9, and 12 months; and then annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Conditions
Prostate Cancer
Being tested
high-intensity focused ultrasound ablation
Keywords
stage I prostate cancer, stage II prostate cancer, recurrent 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.

  • high-intensity focused ultrasound ablationProcedure or surgery

Timeline

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

  1. First posted25 Feb 2004 (estimated)
  2. Study startJul 1999

Why it stopped: Withdrawn because Ablatherm devices were not available anymore at trial centers

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 3
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005075
Sponsor's protocol ID
CDR0000067682
Other IDs
EDAP-G980308, GUMC-99034
Status last verified
May 2009
First submitted
6 Apr 2000
Last updated
6 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing high-intensity focused ultrasound ablation in people with Prostate Cancer, run by EDAP Technomed at 2 sites in United States.

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

Who may be eligible to take part?

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: stopped early, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 phase mean?

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?

The study was stopped early (reason given: Withdrawn because Ablatherm devices were not available anymore at trial centers). 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.

Where can I read the original study information?
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 6 Nov 2013.

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