An Open-label Phase II Study With SUTENT in Patients Suffering From Hormone Refractory Prostate Cancer (PROSUT)
as second-line treatment in metastatic prostate cancer, the present study will investigate the efficacy of sunitinib (SUTENT) given orally at a dose of 37.5 mg continuously, for 6 cycles of 6 consecutive weeks .Patients who are still responders after 6 cycles will be treated until disease progression, pain progression, unacceptable toxicity or death due to any cause.
Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based on individual safety and tolerability.
Follow-up for up to 1 year from the last dose of sunitinib.
Tumor Markers, Biological
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Incidence and intensity of Adverse Events (NCI CTCAE version 3.0). [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
37.5 mg orally once daily, continuously, for 6 cycles of 6 consecutive weeks.Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based on individual safety and tolerability.
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 treatment,
- 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 25(OH)D.
- Angiogenesis markers: bFGF, SDF-1, VEGF-A, VEGFR1 and VEGFR2, CECs and CEPs, endothelial and platelet microparticles.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748358
|Service Oncologie Médicale, Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Principal Investigator:||stephane OUDARD, professor||Assistance Publique - Hôpitaux de Paris|