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ProstAtakTrial- Newly Diagnosed Intermediate and High Prostate Cancer



The American Cancer Society estimates that each year in the U.S. more than 240,000 men are diagnosed with prostate cancer and approximately 30% are at significant risk of disease recurrence with current treatments.  Standard therapy for recurrent prostate cancer is physical or pharmacological castration and chemotherapy or autologous cellular immunotherapy. Chemical castration is not curative and has significant economic, societal, and personal quality-of-life costs. Prevention of prostate cancer recurrence in intermediate and high risk patients is the goal of Advantagene’s Phase 3 study. There is currently no other pharmaceutical or biopharmaceutical treatment approved for this indication or in late state clinical development.  Successful development of GMCI for this indication will provide urologists with a new treatment option for their patients, likely change the standard of care for this disease, result each year in the prevention of tens of thousands of recurrences (and thereby the need for castration therapy) and deaths and save payors billions of dollars.


Results to date from our early clinical studies in prostate cancer, including newly diagnosed prostate cancer, have been extremely promising.  We are currently conducting a randomized, fully blinded, placebo controlled Phase 3 clinical study examining GMCI (ProstAtak) in combination with standard radiation therapy in patients with newly diagnosed, intermediate to high risk localized prostate cancer.  This 711 patient study is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.

 

Study Co-chairs:

Peter Scardino, MD,

Chairman of the Department of Surgery

Memorial Sloan Kettering Cancer Center



Theodore DeWeese, MD

Chairman, Department of Radiation Oncology and Molecular Radiation Sciences

Johns Hopkins Medical Institute     




To download a copy of patient brochure, Click ProstAtak™ patient brochure

Prostate Cancer

“Proactive Surveillance” - Newly Diagnosed Low Risk Prostate Cancer


More than 50% of patients are diagnosed at early stages of disease with low grade, low volume, asymptomatic prostate cancer. Treatments for newly diagnosed prostate cancer include radical prostatectomy, radiation and androgen deprivation therapy (ADT). These treatments have significant short and long-term side effects, including incontinence and impotence.  Postponing treatment is an approach that may preserve quality of life and avoid overtreatment of indolent disease. Active surveillance (AS) is an approach to manage patients with regular PSA and biopsy monitoring of disease status with the intent of deferring radical treatment. AS is currently recommended for men with low risk prostate cancer and is even an alternative for some men with intermediate risk prostate cancer.  Radical treatment is initiated in 25-30% of patients that commence AS within 2-3 years of diagnosis due to Gleason grade, tumor volume and/or PSA progression or patient choice due to “PSA anxiety.”  A low risk active intervention for these patients, such as the administration of GMCI, has the potential to delay or prevent progression without the need for surgery or radiation and their related side effects.  We call this course of action “Proactive Surveillance.”  We have initiated late stage clinical studies using GMCI for this indication with a regional partner.

 

For more information on  PrTK03 study , Click

Clinicaltrials.gov