Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Cancer

  • STATUS
    Recruiting
  • sponsor
    InSightec
Updated on 25 March 2021

Summary

Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Cancer

Description

The MR-guided ExAblate Focused Ultrasound study is being conducted to assess the safety and effectiveness of an investigational device for the treatment of prostate cancer.

The ExAblate treatment is a focal treatment where a small portion of the prostate is treated, only where the cancer is located.

The study will enroll 100 patients with intermediate risk, localized, organ confined prostate cancer. For most study patients, this study will last for up to 26 – 30 months. If you qualify for the study, you will receive the ExAblate treatment.

This clinical research study will evaluate the safety and effectiveness of ExAblate for the treatment of intermediate risk, localized, organ confined prostate cancer.

If you are eligible, you will receive:
  • The ExAblate treatment at no cost
  • Study-related care from a local study doctor

We encourage you to discuss study participation with your physician, family and friends.

For more information, you may also visit: https://www.clinicaltrials.gov/ct2/show/NCT01657942?term=PCa003&rank=1

Details
Condition Prostate Cancer
Clinical Study IdentifierTX149745
SponsorInSightec
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Males age 50 and older
Biopsy proven adenocarcinoma of the prostate
Patient with intermediate risk, early-stage organ-confined prostate cancer and voluntarily chooses ExAblate thermal ablation as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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