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  • MC230502 Dynamic InVestigator INitiated Enterprise (DIVINE) In Prostate Cancer Scottsdale/Phoenix, AZ Jacksonville, FL Rochester, MN

    Prostate cancer is one of the most prevalent malignancies affecting men worldwide, ranging from localized tumors to aggressive, metastatic disease (Siegel et al. 2023). An enormous array of treatments is available for treating prostate cancers, but the field faces a critical challenge in the lack of reliable biomarkers across the spectrum of disease that can direct treatment. This challenge is especially pressing in the current landscape where novel therapeutic approaches and personalized treatments are transforming prostate cancer for our patients.

    This clinical trial aims to address the critical gap in prostate cancer management by rigorously evaluating and validating prostate cancer-derived extracellular vesicles (PC-EVs) across time and treatments. Critically, we seek to define these questions for patients among under-represented populations in this multi-group, multi-department, multi-center, investigator-initiated trial.
  • Positron Emission Tomography Using 64Cu-SAR-bisPSMA In Participants With High-risk Prostate Cancer Prior To Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study Scottsdale/Phoenix, AZ Jacksonville, FL Rochester, MN

    The purpose of this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
  • RAP: Prospective Pragmatic Multi-Site Trial Evaluating The Feasibility And Effect Of Wrapping The Cavernous Nerves With A Novel Multi-Layer Perinatal Tissue Allograft During Prostatectomy Jacksonville, FL This clinical trial studies whether a new multi-layer perinatal tissue allograft, MLG-Complete (Trademark), can be used to improve complications after nerve-sparing robot-assisted radical prostatectomy (RARP) in patients with prostate cancer that has not spread to other parts of the body (localized). Two major complications that can happen after complete surgical removal of the prostate (radical prostatectomy) include erectile dysfunction and urinary incontinence, both of which greatly affect a patient's quality of life and social well-being. The goal of nerve-sparing radical prostatectomy is to preserve erectile and urinary function, but damage to the surrounding nerves and blood vessels can still occur causing the patient to experience the complications. An allograft is the transplant of an organ, tissue, or cells from one individual to another individual of the same species who is not an identical twin. The MLG-Complete allograft is made up of perinatal tissue and is placed on the nerve bundles during a nerve-sparing RARP. It is meant to serve as a barrier and provide coverage to the nerve bundles from the surrounding environment, which may improve post-nerve-sparing RARP complications.

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  • Integration Of PSMA PET Imaging And Extracellular Vesicle-Based Tumor Monitoring For Biochemically Recurrent Prostate Cancer Scottsdale/Phoenix, AZ

    The purpose of this study is to develop an inexpensive and non-invasive blood test that can help refine the identification of patients with PSMA-positive metastatic lesions following biochemical recurrence. 
  • RAP: Prospective Pragmatic Multi-Site Trial Evaluating The Feasibility And Effect Of Wrapping The Cavernous Nerves With A Novel Multi-Layer Perinatal Tissue Allograft During Prostatectomy Scottsdale/Phoenix, AZ Rochester, MN This clinical trial studies whether a new multi-layer perinatal tissue allograft, MLG-Complete (Trademark), can be used to improve complications after nerve-sparing robot-assisted radical prostatectomy (RARP) in patients with prostate cancer that has not spread to other parts of the body (localized). Two major complications that can happen after complete surgical removal of the prostate (radical prostatectomy) include erectile dysfunction and urinary incontinence, both of which greatly affect a patient's quality of life and social well-being. The goal of nerve-sparing radical prostatectomy is to preserve erectile and urinary function, but damage to the surrounding nerves and blood vessels can still occur causing the patient to experience the complications. An allograft is the transplant of an organ, tissue, or cells from one individual to another individual of the same species who is not an identical twin. The MLG-Complete allograft is made up of perinatal tissue and is placed on the nerve bundles during a nerve-sparing RARP. It is meant to serve as a barrier and provide coverage to the nerve bundles from the surrounding environment, which may improve post-nerve-sparing RARP complications.

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