An Open Label Phase II Study of Oral Treatment With Sunitinib (SUTENT) in Patients Suffering From Hormone Refractory Prostate Cancer After Progression With Docetaxel Based Regimen
- Antitumor efficacy of sunitinib will be assessed as follows:
- PSA response rate and PSA progression according Working Group Criteria,
- Variation of PSA doubling time (PSADT) before and after initiation of the
- Objective response rate (ORR) according to RECIST criteria,
- Clinical benefit,
- Overall survival (OS).
- Pharmacokinetic endpoints will include sunitinib and its metabolite, SU012662, plasma
levels and estimation of the population pharmacokinetic parameters as well as the
inter-individual variability of these parameters, for a subgroup of 30 patients.
- The biological effects of sunitinib in patients with metastatic prostate carcinoma will
be evaluated by measurements of the different biological markers that could be
modulated by this antiangiogenic therapeutic, and could then predict and monitor
disease progression and response to treatment:
- Bone tumor markers: bone resorption markers (uCTX, uCTX, ICTP, CTX-MMP and
TRACP-5b), bone formation markers (OC, PINP and BALP), osteoclastogenesis markers
(OPG and RANKL) and parameters as calcium, phosphate, creatinine, albumin, PTH and
- Angiogenesis markers: bFGF, SDF-1, VEGF-A, VEGFR1 and VEGFR2, CECs and CEPs,
endothelial and platelet microparticles.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
progression-free survival (PFS) defined as the time from start of study treatment to first documentation of objective progressive disease, pain progression or to death on-study due to any cause.
stephane OUDARD, professor
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health