drugset

drugset / Trial / NCT00715104

Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer

NCT00715104 ↗

Phase 2 Completed 42 enrolled Dendreon University of California, San Francisco · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.

Timeline

Start: 2008-07
Primary completion: 2012-12
Completion: 2013-12

Outcome

Mixed primary results

registry Biopsy Benign Tissue vs Post-RP Benign Tissue; p = 1.000 NCT00715104 ↗

registry Biopsy Benign Tissue vs Post-RP Tumor Tissue; p = 1.000 NCT00715104 ↗

registry Biopsy Benign Tissue vs Post-RP Tumor Interface; p <0.001 NCT00715104 ↗

registry MEAN Biopsy Benign Tissue: 2.33 (Standard Error 0.34) cells/μm2 NCT00715104 ↗

registry MEAN Post-RP Tumor Interface: 6.39 (Standard Error 0.61) cells/μm2 NCT00715104 ↗

Publications

Sheikh N, Cham J, Zhang L, DeVries T, Letarte S, Pufnock J, Hamm D, Trager J, Fong L. Clonotypic Diversification of Intratumoral T Cells Following Sipuleucel-T Treatment in Prostate Cancer Subjects. Cancer Res. 2016 Jul 1;76(13):3711-8. doi: 10.1158/0008-5472.CAN-15-3173. Epub 2016 May 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sipuleucel-T	Cell therapy	—	—

Indications