An open-label study of Sipuleucel-T (Provenge) is ongoing at 8 centers across the USA. This is a Phase 2 Study enrolling men with Metastatic Castrate Resistant Prostate Cancer (CRPC).
The aim of this study is to measure the immune responses to treatment with sipuleucel-T (Provenge). All participants will receive the drug.
"Subjects will receive the investigational product, sipuleucel-T, at approximately 2-week intervals, for a total of 3 infusions. The study will evaluate the safety of and magnitude of the immune responses to treatment with sipuleucel-T. All subjects will be followed for 30 days following the last infusion of sipuleucel-T. The study is also available to placebo subjects who participated in the D9902B study."
If you want to participate and believe you may fit the profile, you or your doctor should contact one of the 8 study centers. Here are the basics:
Men are eligible for this trial if they have:
- Hormone refractory prostate cancer, testosterone below 50
- Metastatic stage disease
- PSA at least 5.0
- no lung, liver, or brain mets
- No evidence of neuroendocrine or small cell PCa.
- No imminent danger of spontaneous bone fracture or spinal cord compression.
In addition, at least 28 days since:
- radiation or surgery
- PC-SPES (or PC-SPEC) or Saw Palmetto
- Megace(R), diethylstilbesterol (DES), ketoconazole (Nizoral), or cyproterone acetate
- 5-alpha-reductase inhibitors (Proscar or Avodart)
- Antiandrogens (Casodex, flutamide, Nilandron)
- High dose calcitriol (i.e., > 0.5 mg/day)
More details are available from clinicaltrials.gov (link below)
Current Trial Sites:
- Park Ridge, Illinois
- Greenbelt, Maryland
- Durham, North Carolina
- Norfolk, Virginia
- NY, NY (2 centers)
- Seattle, WA
Full outline of the trial requirements at clinicaltrials.gov:
Open Label Study of Sipuleucel-T