Dendreon Finally Completes Its FDA Submission for the Approval of Provenge

Finally, on Monday, Dendreon announced that it completed its Food and Drug Administration (FDA) application for the approval of Provenge (sipuleucel-T). Provenge is designed as a vaccine that stimulates the body's own immune system to fight prostate cancer. It is a different type of vaccine from what most of us knows as it is given [...]

On the Horizon – Phase III Trial of MDV3100 in Advanced Prostate Cancer Begins

Medivation, Inc. (MDVN) has formally begun its phase III trial of the investigational drug MDV3100 with men who have advanced prostate cancer. The clinical trial known as AFFIRM will evaluate the novel androgen receptor antagonist, MDV3100, in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. AFFIRM is a randomized, placebo-controlled, double-blind, [...]

Abiraterone Acetate (CB7630) Phase II Data Released At The ASCO Annual Meeting

At the ASCO Annual meeting in Orlando Florida, Cougar Biotechnology, Inc. announced perliminary results from their ongoing Phase II clinical trials of their much discussed investigational drug abiraterone acetate (CB7630). The company released some preliminary encouraging data in three separate poster presentations. First, I want to tell you what abiraterone acetate is. In scientific jargon [...]

Late Stage Clinical Trials

I compiled a list of trials that are activily recruiting men with hormone refractory prostate cancer (HRPC) who have also failed chemotherapy (taxotere). Being at this point in the disease process is by far the scariest time. We face the reality that there are no more approved treatments available to control the cancer. Clinical trials [...]

On The Horizon- FDA Grants Fast Track Designation for OGX-011 in The Treatment of Prostate Cancer

OncoGenex Pharmaceuticals, Inc. (OGXI) announced that it's experimental product, OGX-011, also known as custirsen sodium, received fast track designation from the U.S. Food & Drug Administration (FDA) for the treatment of progressive metastatic prostate cancer in combination with first-line docetaxel treatment (chemotherapy). OGXI had previously received this same designation for second-line docetaxel treatment with OGX-011 [...]

On The Horizon – Sunitinib Malate for Metastatic Castration-Resistant Prostate Cancer Following Docetaxel Chemotherapy

Dr. Guru Sonpavde, MD (Clinical Assistant Professor, Baylor College of Medicine) reported about an open label, phase II trial of sunitinib (Sunitinib, marketed as Sutent, and previously known as SU11248 is an oral, small-molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor that was approved by the FDA for the treatment of renal cell carcinoma (RCC) and [...]

On the Horizon – Estrogen Receptor Modulator Reduces Bone Complications from Androgen Deprivation Therapy for Prostate Cancer

A multi-center Phase III study discussed at the 2009 meeting of the American Urological Association,[1] has demonstrated that the risk for bone fractures in men on androgen deprivation therapy (ADT) can be reduced by using toremifene (Acapodene). Men, fighting advanced prostate cancer, often receive long-term ADT, which along with other side effects will increase their [...]

On the Horizon – Estrogen Receptor Modulator Reduces Bone Complications from Androgen Deprivation Therapy for Prostate Cancer

A multi-center Phase III study was discussed at the 2009 meeting of the American Urological Association.[1] The perliminar results of this study has demonstrated that the risk for incurring bone fractures in men on androgen deprivation therapy (ADT) is reduced when the drug toremifene (Acapodene) is administered. Men, fighting advanced prostate cancer, often receive long-term [...]

PET/CT Scans May Help Detect Recurring Prostate Cancer Earlier

The September issue of The Journal of Nuclear Medicine published a study that shows that positron emission tomography (PET)/computer tomography (CT) scans using the imaging agent choline could detect recurring prostate cancer sooner than conventional imaging technologies in some patients who have had their prostates surgically removed. Men who elect to have a radical prostatectomy [...]

On the Horizon – Sunitinib Malate for Metastatic Castration-Resistant Prostate Cancer Following Docetaxel Chemotherapy

Docetaxel (Taxotere), or chemotherapy, will as all other treatments for advanced prostate cancer stop working. Many of us will progress quickly to this stage and eventually face a situation where there are no longer any approved treatments available to control our prostate cancer. If you are lucky enough to have an oncologist who is creative [...]

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