Status:
UNKNOWN
Prostate Cancer, Androgen Deprivation Withdrawal and Intermittent Chemotherapy
Lead Sponsor:
University of Turin, Italy
Conditions:
Advanced Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
The study includes the recruitment of patients with advanced prostate cancer resistant to chemical castration This is a multicenter prospective trial randomized phase III
Detailed Description
The study includes the recruitment of patients with advanced prostate cancer resistant to chemical castration This is a multicenter prospective trial randomized phase III This study design that includ...
Eligibility Criteria
Inclusion
- age over 18 years,
- histologically documented adenocarcinoma of the prostate,
- written informed consent to the study,
- Castrate resistant metastatic prostate cancer in the presence of castrate levels of testosterone (\<50 ng/ml) and eligible to docetaxel chemotherapy. The condition of castrate resistant prostate cancer is the defined either as the documentation of a new metastasis or PSA increase more than 50% or increase more than 25% from a lower PSA value during previous hormone therapy in case of disease response or stabilization to previous hormone therapy, respectively. Absolute PSA increase should be greater than 5 ng/ml,
- an elevated PSA level must have been documented within 4 weeks of initiating docetaxel chemotherapy,
- more than 4 weeks since major surgery and fully recovered,
- more than 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to grade 1 or less,
- more than 8 weeks since the last dose of strontium or samarium,
- ECOG Performance Status more than/equal to 2,
- life expectancy \>6 months,
- required initial laboratory values: absolute neutrophil count \> 1500/ul Platelets \> 100,000/ul., Hemoglobin \> 8.0 g/dl, Creatinine, SGOT, SGPT less than 2.0 X upper limit of normal, Bilirubin less than/equal to upper limit of normal (ULN).
- Appropriate patient compliance
Exclusion
- Patients with increased serum PSA levels with negative bone scan and CT scan.
- Prior systemic chemotherapy for prostate cancer. Prior neoadjuvant or adjuvant chemotherapy is permitted if there was no evidence of disease relapse within 12 months of the last dose of chemotherapy,
- Peripheral neuropathy \>grade 1,
- myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (NYHA Class III or higher) or uncontrolled cardiac arrhythmia,
- patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80,
- poorly controlled diabetes (fasting blood glucose \>250) despite optimization of medical therapy, peptic ulcers or other contraindications to steroid therapy,
- previous history of malignant disease with the exception of non melanoma skin cancer curatively treated,
- significant neurologic or psychiatric diseases preventing patients to give a valid informed consent,
- brain metastases,
- prisoner status
- because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded.
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Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01224405
Start Date
April 1 2010
End Date
April 1 2016
Last Update
October 20 2010
Active Locations (32)
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1
Davide Perroni
Saluzzo, Cuneo, Italy
2
Roberto Faggiuolo
Alba, Italy
3
Franco Testore
Asti, Italy
4
Mario Clerico
Biella, Italy