Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer

• Status: Unknown status
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes induced by docetaxel in HRPC patients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Docetaxel; Sunitinib

Criteria

Inclusion Criteria:

• WHO performance status of 0-2.

• Histologically proven prostate adenocarcinoma.

• All patients must have prostate adenocarcinoma that is unresponsive or refractory to androgen ablation with biochemical progression

• Measurable and/or evaluable progressive disease, which is defined by one of the following three criteria:

• 25% increase in bidimensionally measurable soft tissue metastases

• Appearance of new metastatic lesions (proven by CT scan, X-ray or bone scan)

• PSA level of at least 10ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart

• If the patient has been treated with antiandrogens, treatment must have been stopped at least 6 weeks prior to study randomization

Exclusion Criteria:

• prior chemotherapy for prostate cancer