Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-Resistant Prostate Cancer

Not Applicable

• Conditions: -C61 Malignant neoplasm of prostate; Malignant neoplasm of prostate; C61

• Registration Number: PER-131-08
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-28
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 39

Inclusion Criteria

• Patients must sign an informed consent stating that they have understood the investigative nature of the proposed treatment.
• History of histologically diagnosed prostate cancer.
• Evidence of metastatic disease by one of the following means: CT, MRI, bone scintigraphy or skeletal analysis.
• Evidence of progression by any of the following means: Increasing PSA values ​​with at least 1 week difference and a final value> 2 ng / ml, or Progression of measurable ganglionic or visceral disease, or Two (2) or newer obvious lesions due to bone scintigraphy compared to a previous scintigraphy, or local recurrence in the prostate or prostate bed
• Maintenance of castration status: patients who did not undergo surgical orchiectomy should have received and continued medical treatments [such as gonadotropin-releasing hormone analogues (GnRH analogues)] to maintain castration levels in serum testosterone <50 ng / dl (1.7 nmol / 1).
• General status ECOG 0-2.
• At least 4 weeks after major surgery, radiation therapy and a research agent.
• At least 8 weeks after a radioisotope treatment (for example, strontium 89, samarium 153 or similar agents)
• Recovery of local primary treatment by surgery or radiation.
• Only men at least 18 years of age.

Exclusion Criteria

• Women.
• Sexually active fertile men who do not use an effective contraceptive method if their partners are women of childbearing age.
• Patients with active brain or leptomeningeal metastases will be excluded from this study.
• Clinically significant cardiovascular diseases, including myocardial infarction or ventricular tachyarrhythmia within a period of 6 months, prolonged QTc> 450 msec, ejection fraction (EF) <40% or major conduction abnormalities (unless there is a pacemaker).
• Pre-existing pleural or pericardial effusion with CTC of any grade.
• Peripheral neuropathy with CTC grade> 2.
• Patients with a second currently active malignant cancer that is not nonmelanoma skin cancer will not be included in the study. Patients will not be considered to have a currently active malignant disease if they have finished a treatment and their doctor currently considers that they have less than 30% risk of recurrence.
• Concurrent uncontrolled disease, such as continuous or active infection, cardiac arrhythmia, psychiatric illness or social situations that would limit compliance with the study requirements.
• HIV positive patients receiving combined antiretroviral treatment.
• History of allergic reactions attributed to compounds of chemical or biological composition similar to that of the agents under investigation.
• Patients cannot receive any other investigating agent for prostate cancer.
• Patients should not have previously received cytotoxic chemotherapy for metastatic disease, with the exception of estramustine.
• Patients may continue taking daily multivitamins, but all dietary, alternative or herbal supplements (such as PC-Spes, serenoa rapens (dwarf palm), St. John´s Wort, etc.) should be discontinued before entering the study.
• Ketoconazole should be discontinued four weeks before starting the study treatment.
• Antiandrogens should be discontinued before beginning study treatment. Patients with a history of antiandrogen response and subsequent progression with the administration of the same agent should undergo controls to detect responses that would withdraw them from the study for 4 weeks. This control will not be necessary for patients who have never responded to antiandrogens.
• Do not start taking bisphosphonates within 28 days before the start of the study treatment.
• QT interval prolongation agents associated with Torsade de Pointes arrhythmia

Study & Design

• Study Type: Interventional
• Study Design: Not specified