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Prostate Cancer

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GPC Biotech announced that the Oncologic Drugs Advisory Committee (ODAC) for the US Food and Drug Administration (FDA) recommended (12–0) that the FDA should wait for the final survival analysis of the SPARC trial before deciding whether satraplatin is approvable for the treatment of hormone-refractory prostate cancer patients whose prior chemotherapy has failed.

GPC Biotech had sought accelerated approval for its drug for the treatment of hormone-refractory (androgen-independent) prostate cancer (HRPC) that had failed prior chemotherapy on the basis of findings from a protocol-specified preliminary analysis that showed a 33% reduction in the risk of disease progression

Prostate cancer patients who showed central abdominal uptake (CAU) on imaging with capromab pendetide (ProstaScint) had prostate-cancer-specific death rates 10 times higher than those without CAU

Prostatic acid phosphatase (PAP) emerged as the world's first clinically useful tumor marker in the 1940s and 1950s. With the introduction of the prostate-specific antigen (PSA) test in the 1980s, which performed significantly better than PAP in terms of screening and monitoring response to treatment, PAP fell into disfavor. An increasing number of recent studies have identified PAP as a significant prognostic factor for patients with intermediate- and high-risk prostate cancer. PAP appears to be particularly valuable in predicting distant failure in higher-risk patients for whom high levels of local control are achieved with aggressive initial local treatment. As prostate cancer care becomes increasingly focused on identifying the minority of patients who would benefit from aggressive systemic therapy, a reevaluation of the potential contribution of the prostatic acid phosphatase test seems timely.

LOS ANGELES—Cougar Biotechnology, Inc.'s CB7630 (abiraterone acetate) was well tolerated at doses as high as 2,000 mg/d with minimal toxicity in a phase I/II trial of chemotherapy-naive patients with castration-refractory prostate cancer, who had progressive disease despite treatment with LHRH analogs and multiple other hormonal therapies. Of 30 evaluable patients, 18 (60%) had a confirmed decline in PSA of greater than 50%, while 10 (33%) had declines greater than 90%. Of 20 evaluable patients with measurable lesions, 11 (55%) had a partial radiological response, while 7 had ongoing stable disease and 3 had regressing bone disease. The data were presented at the American Urological Association (AUA) annual meeting.

Dendreon Corporation recently announced that it received a Complete Response Letter, commonly referred to as an "approvable" letter, on May 8, 2007 from the US Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for sipuleucel-T (Provenge) for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer.

Endocare, Inc, a medical device company focused on the development of minimally invasive technologies for tissue and tumor ablation, announced that a randomized clinical trial of 244 men with localized prostate cancer demonstrated that cryoablation, a minimally invasive method of freezing cancerous tumors to destroy them, is at least as effective as external-beam radiation when used to treat localized prostate cancer

Dendreon Corporation recently announced that it received a Complete Response Letter, commonly referred to as an "approvable" letter, on May 8, 2007 from the US Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for sipuleucel-T (Provenge) for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer.

The advent of prostate-specific antigen (PSA) screening has increased early detection and treatment of prostate cancer. Most patients respond well to prostatectomy or localized radiation therapy if the cancer is diagnosed before it metastasizes. As a result, the mortality rate from prostate cancer has fallen significantly since the late 1980s.

The American Society of Clinical Oncology (ASCO) has updated its 2004 clinical practice guideline on the initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer

Spectrum Pharmaceuticals, Inc, recently announced that the New Drug Application (NDA) for satraplatin has been accepted for priority review by the US Food and Drug Administration (FDA). A Prescription Drug User Fee Act date of August 15, 2007, has been established by the FDA for a decision regarding the approval of the satraplatin application. Satraplatin is an investigational drug for the treatment of hormone-refractory prostate cancer in patients who have failed prior chemotherapy.

The advent of prostate-specific antigen (PSA) screening has increased early detection and treatment of prostate cancer. Most patients respond well to prostatectomy or localized radiation therapy if the cancer is diagnosed before it metastasizes. As a result, the mortality rate from prostate cancer has fallen significantly since the late 1980s.

patient is a 67-year-old male with mild obstructive symptoms and an American Urology Association symptom score of 8.[1] He was noted to have a prostate-specific antigen (PSA) level of 3.2 ng/mL. Because this represented a significant increase in his PSA velocity (rate of change over time), he proceeded to have a biopsy, which was positive for prostate cancer. He has no other complaints and visits us for an opinion on the treatment of his prostate cancer.