Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer

Medical University of Vienna60 enrolled

Overview

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

Docetaxel (75mg/m2 q21d) is standard of care for patients with hormone refractory prostate cancer (HRPC). Recent data indicate, that chemotherapeutics given at MTD induce, besides their cytotoxic effects, mobilization of circulating endothelial cells (CEC) and - progenitors (CEP) in drug-free breaks of each cycle. In preclinical models, mobilized CEC/CEP result in tumor vasculogenesis and progression of disease. We hypothesize that treatment with sunitinib, an anti-angiogenic tyrosine kinase inhibitor, in between 3 weekly docetaxel disrupts CEC/CEP spikes following docetaxel leading to chemosensitization and reduced tumor re-growth in HRPC patients responding to docetaxel.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Hormone Refractory Prostate Cancer

Interventions

Docetaxel * SunitinibDRUG

docetaxel 75mg/m2 day1 q 21d x 4 cycles, sunitinib 37.5mg/d day2 -day15 x 4 cycles

DocetaxelDRUG

docetaxel 75mg/m2 day1 q 21d x 4 cycles

DocetaxelDRUG

Docetaxel 75mg/m2 q21d for 4 cycles

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept of Internal Medicine

Vienna, Austria

RECRUITING

Outcomes

Primary Outcomes

Primary: CEC/CEP spikes induced by MTD docetaxel in patients treated with docetaxel/sunitinib relative to docetaxel monotherapy

Time frame: 12 weeks

Secondary Outcomes

Response rate and length of treatment holidays relative to docetaxel monotherapy

Time frame: 6 months

Central Contacts

Michael MK Krainer, MD

CONTACT

+43 1 40400 michael.krainer@meduniwien.ac.at

Data from ClinicalTrials.gov

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