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NOTE: This set of pages will be updated on or around May 1,2007.  Meanwhile, please visit our news blog for advanced and recurrent prostate cancer, http://www.advancedprostatecancer.net   
Provenge
is a vaccine currently in two randomized double-blind, placebo-controlled trials for patients with asymptomatic metastatic hormone-refractory prostate cancer and patients with rising PSA after prostatectomy but no other signs of disease. Patients in the hormone refractory trial must have a pathology record stating that their original tumor was graded as a Gleason Score of 7 or lower. Patients are randomized to either the treatment or control group in a 2: 1 ratio. In the metastatic trial, approximately 275 patients will be enrolled in approximately 60 sites in the United States. The treatment group receives Provenge, which consists of APCs loaded with prostatic acid phosphatase.

The control group receives placebo. At baseline, before the first apheresis (blood filtering for dendritic cells), the patient must undergo screening tests to determine eligibility. At weeks 0, 2, and 4, all patients undergo apheresis followed by an infusion 2 days later with either Provenge or a control. This is the active treatment phase. If a patient's disease progresses after the active treatment phase, further treatment is at the physician's discretion. If the patient is in the control group and progresses, he may have the option to join the open-label salvage protocol (i.e., receive the active vaccine).

Potential adverse effects can occur during the collection of dendritic cell precursors (leukopheresis) and during and after reinfusion of Provenge. During apheresis, patients may experience citrate toxicity (numbness and tingling around the mouth and hands) and, rarely, arrhythmias due to low calcium secondary to anticoagulants used during apheresis. In addition, hypovolemia (decrease in the volume of circulating blood) and low blood pressure may occur, as well as pain, bruising, and infection at the venous catheter site. Reinfusion can be complicated by chills, fevers, muscle ache, pain, and fatigue (Burch et al., 2000). In addition to apheresis or infusion- related incidents, there is the theoretical possibility that patients may experience prostatitis due to the induction of an immune response to PAP; therefore, the PSA may rise without disease progression.

Phase I and II trials of Provenge at the University of California at San Francisco and the Mayo Clinic demonstrated that Provenge is generally well tolerated (Valone et al., 2001). In the Mayo Clinic trial, patients received two doses of intravenous Provenge every 4 weeks, followed by three doses of PAP-GM-CSF subcutaneously every 4 weeks. The UCSF trial used Provenge only. Patients in the UCSF study had a higher frequency of antibody responses and higher antibody titers. A substantial number of patients experienced disease stabilization and a longer than expected time to disease progression. Several patients had objective tumor regression on CT scan, and there was decreased PSA in about 20 percent. Both trials supported the efficacy, safety, and tolerability of Provenge in treating hormone-refractory prostate cancer patients.

A double-blind placebo-controlled, randomized, phase III trial was initiated in late 1999 and completed enrollment by mid-2001. A second phase III trial is currently in progress. In late 2002, the Dendreon Corporation announced the results of its first placebo-controlled phase III trial of Provenge: "In addition to delaying the time to disease progression, the investigational cancer vaccine delayed the onset of disease-related pain in patients with hormone-resistant prostate cancer with a Gleason score of 7 or less." For these patients, the probability of remaining free of cancer-related pain while in the study was over 2.5 times higher than forpatients treated with placebo. In the same group of patients, median time to disease progression was 9.1 weeks among placebo patients compared to 16.1 weeks in the Provenge-treated group, with a highly significant p value of 0.001 and a treatment effect of 77 percent. In addition, after 6 months of follow-up, the patients receiving Provenge had a progression-free survival nine times that of patients who received placebo (35.9% versus 4%).

In the future, Provenge may be used to delay the need for androgen- deprivation therapy. This is being tested in another trial in patients with hormone-sensitive prostate cancer who have a rising PSA level as the only sign of disease recurrence after radical prostatectomy. Entry into this trial is not restricted on the basis of Gleason Score. In the future, it is hoped that Provenge will be given to prostate cancer patients at high risk of developing a recurrence or at the first detection to enhance the immune system's ability to eradicate cancer cells in the microscopic stage before development of a tumor.

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