While Provenge (Sipuleucel-T) is not yet FDA approved, it may be available in a new Dendreon-sponsored multicenter, open label (no placebo), phase 2 study for men with metastatic castrate-resistant prostate cancer, if a man fits the eligibility requirements. (Note: This trial is different from the previous ProACT trial, which used lower concentrations of Sipuleucel-T, and required that men live close to the trial site). The trial is also available to those men who received placebo during the previous trial.

Some basic criteria (see link below for the full list) for being considered include having:

Metastatic disease
Castrate-resistant prostate cancer (this means men who no longer respond to surgical or medical castration, such as hormone therapy)

PSA of at least 5.0 ng/mL
(* NOTE - watch for this criteria to change in a few days. )
watch at http://www.clinicaltrials.gov/ct2/show/NCT00901342?term=provenge&recr=Open&rank=2

Castrate level of testosterone (less than 50 ng/dL) achieved via medical or surgical castration
Life expectancy of at least 3 months
Adequate hematologic, renal and liver function
No lung, liver, or brain metastases

It must also be at least 28 days since a man has: used systemic corticosteroids (use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (ie, less than or equal to 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans); used non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide); had external beam radiation therapy or major surgery requiring general anesthetic; had any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace), diethylstilbestrol (DES), and ketoconazole; received chemotherapy; or had treatment with any other investigational product.

Current trial sites include Park Ridge, Illinois; Greenbelt, Maryland; Durham, North Carolina; Norfolk, Virginia; New York, New York; and Seattle, Washington. Men must contact the trial site they are interested in to find out if they meet all the criteria. To learn more, including the phone numbers of the trial sites, click here>>

Link to Trial:  http://www.clinicaltrials.gov/ct2/show/NCT00901342?term=provenge&recr=Open&rank=2Video re: Provenge - http://activation.dendreon.com

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Tags: Dendreon, Prostate Cancer, prostate cancer trials, provenge, sipuleucel-t

This entry was posted on Wednesday, November 25th, 2009 at 1:43 pm and is filed under The Cause, The Dysfunctional FDA. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.