• linkedin
  • Increase Font
  • Sharebar

    Uro Pipeline: NDA submitted for non-metastatic castration-resistant PCa agent



    Imaging modality leads to changes in prostate cancer management

    Results of a recent interim analysis showed that 61.2% (52/85) of prostate cancer patients had their clinical management changed when results of fluciclovine (18F) positron emission tomography/computed tomography imaging were added to the standard-of-care diagnostic workup. Results from the phase III FALCON trial were presented at the American Society for Radiation Oncology annual meeting in San Diego. The study is evaluating the clinical impact of fluciclovine (18F) PET/CT imaging on patient management decisions in men with biochemically recurrent prostate cancer, according to Blue Earth Diagnostics. Fluciclovine F 18 injection (Axumin) is an FDA-approved molecular imaging agent for use in PET imaging in men with suspected prostate cancer recurrence based on elevated PSA levels following prior treatment. It is not currently approved in the United States for treatment planning in men with biochemically recurrent prostate cancer.


    Treatment underway for patients in clinical trial of BPH treatment

    The first patients have been treated in the WATER II Study (Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue). The WATER II study is a U.S. investigational device exemption clinical trial evaluating the safety and efficacy of Aquablation, delivered with PROCEPT BioRobotics’ AQUABEAM System, in large prostates (80 mL to 150 mL) for the treatment of BPH. The study will enroll 100 patients at up to 20 sites in the U.S. and Canada, with patient follow-up out to 12 months. The WATER II Study is a follow-up study to the successful WATER Study, which showed a superior safety profile for Aquablation with very strong efficacy outcomes comparable to transurethral resection of the prostate for the treatment of BPH in prostates 30 mL to 80 mL, according to PROCEPT BioRobotics.

    Next: Urinary incontinence agent’s new drug application accepted by FDA


    You must be signed in to leave a comment. Registering is fast and free!

    All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

    • No comments available


    View Results