New Phase I/II trial of InSightec’s MRI-guided focal ultrasound therapy


According to a media release issued yesterday by the City of Hope medical center in Los Angeles, they have become the first center in the USA to treat a patient with focused, MRI-guided, ultrasound technology using the InSightec system.

The initial patient appears to have been treated under this clinical trial protocol described on the ClinicalTrials.gov web site.

InSightec’s MRI-guided ultrasound system is approved by the US Food and Drug Administration to treat painful bone metastases, and has been used in other countries to treat localized prostate cancer. Application of this technology permits focal therapy of small areas of the prostate as opposed to ablation of the entire prostate.

The current trial is limited to men between 55 and 75 years of age with low-risk, early-stage, organ-confined prostate cancer (clinical stages T1c and T2a) who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy. Patient must have a PSA level of ≤ 10 ng/m, a PSA density < 0.15 ng/ml/g and a Gleason score of 3 + 3 = 6 or less (with no Gleason pattern 4 or 5 cancer) based on a TRUS-guided mapping prostate biopsy, as defined in the protocol.

Only 40 patients are supposedly going to be enrolled in this initial trial, so it is clearly a Phase I/II “proof of concept” study.

 

3 Responses

  1. INTERESTING, BUT PUZZLING CHOICE OF STUDY GROUP

    It’s always good to see new options explored that have some credibility.

    However, I’m curious about the choice of men with low- to very low-risk prostate cancer as the study group. While the protocol should smoke out side effects during the first 6 months, the protocol also looks at effectiveness in terms of tumor control. The eligibility and exclusion criteria will result in a group that should do fine, especially as early as 6 months after treatment, even if they have no treatment of any kind. Indeed, these patients are being recruited from patients following watchful waiting or active surveillance.

    If I were judging this study during proposal review, my enthusiasm for the study would be greatly decreased by the seeming lack of any challenge in coping with cancer. Am I missing something here?

    The ClinicalTrials.gov site is not yet showing this trial, but details are available on the City of Hope site.

  2. Dear Jim (and others):

    Actually, this trial protocol is accessible through ClinicalTrials.gov. There must have been a typo when I inserted the link originally. Sorry.

  3. Very interested in what the urology chair at City of Hope has to say. I will write him. They are known for some excellent surgeons. This is an interesting deviation.

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