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. Author manuscript; available in PMC: 2016 May 31.
Published in final edited form as: Urol Oncol. 2007 Dec 21;26(4):438–444. doi: 10.1016/j.urolonc.2007.03.029

Table 2.

Ongoing single-agent trialsa

Agent Phase Target population No. patients Comments
ProVenge® (sipuleucel-T) IIII Metastatic HRPC 500 IMPACT (immunotherapy in metastatic prostate adenocarcinoma treatment), 2:1 randomized, double-blinded trial comparing ProVenge I.V. q 2 weeks × 3 to empty vector. Primary endpoint is overall survival. Crossover to a second-line active treatment protocol is allowed for the control group upon progression.
GVAX® prostate III Progressive, metastatic HRPC, asymptomatic 600 VITAL-1 (vaccine immunotherapy with allogeneic prostate cancer cell Lines), 1:1 randomized, unblinded trial comparing first line immunotherapy (GVAX q 2 weeks × 13) to standard chemotherapy (docetaxel q 3 weeks × 9). Primary endpoint is overall survival.
Ipilimumab (MDX-010) I/II Metastatic HRPC, no chronic narcotic pain medication, prior chemotherapy allowed 34 Open-label, multi-site dose-escalation study of MDX-010 q 3 weeks × 4 doses.
a

Current data available at www.clinicaltrials.gov.

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