Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT00757692
Brief Summary:
Purpose To define the efficacy, tolerability and safety of Vandetanib in combination with bicalutamide in patients with chemotherapy naive hormone refractory prostate cancer
Hypothesis There will be a PSA response when Vandetanib is given in combination with Bicalutamide in Chemotherapy Naive Hormone refractory prostate cancer patients.
Detailed Description:
With the advent of PSA surveillance, many patients diagnosed with hormone refractory disease, have PSA rising disease only, are asymptomatic, with no evidence of metastatic disease. There is no standard of care in this patient population. A standard treatment in this population has been the addition of a non-steroidal anti androgen such as bicalutamide. PSA response rate (defined as a 50% decrease) have been reported in 20% range with bicalutamide.
Even in patients with hormone refractory prostate cancer (HRPC) and metastases that have no cancer related symptoms, initiation of chemotherapy is controversial given the palliative nature of chemotherapy and potential for serious toxicity.
These patients are generally well enough to to undergo trials of novel agents and achieve adequate drug exposure, such that any cytostatic effect will be apparent.
Study:
NCT00757692
Study Brief:
Protocol Section:
NCT00757692