According to a corporate press release just issued, Dendreon has initiated a Phase 2 trial of PROVENGE® (sipuleucel-T) in men with localized prostate cancer who are scheduled to undergo a radical prostatectomy. The so-called NeoACT (NEOadjuvant Active Cellular immunoTherapy) trial will be conducted at the UCSF Helen Diller Family Comprehensive Cancer Center, and will enroll approximately 40 patients. NeoACT is the first of two new Phase 2 trials of PROVENGE being initiated this year.
Each patient will receive a complete course of active treatment over a 1-month period beginning 6-7 weeks prior to the patient’s radical prostatectomy. The course of treatment will consist of three infusions of PROVENGE, each 2 weeks apart. Following radical prostatectomy, patients will be randomized to receive either a booster of PROVENGE or no booster. Patients interested in additional information about this trial will find the details on the ClinicalTrials.gov web site.
The “New” Prostate Cancer InfoLink believes that the potential of Provenge in treatment of early stage disease may be significantly higher than its potential in late stage disease, where prior trials have been carried out. It will be interesting to see whether such potential is demonstrated in this early stage trial.
Filed under: Drugs in development, Management, Treatment
