Overview

This trial is active, not recruiting.

Condition advanced prostate cancer
Treatments docetaxel + lh-rh analogues, docetaxel, continuous docetaxel
Phase phase 3
Sponsor University of Turin, Italy
Start date April 2010
End date August 2010
Trial size 600 participants
Trial identifier NCT01224405, EudraCT 2010-019004-24

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
ten docetaxel cycles + maintenance androgen deprivation.
docetaxel + lh-rh analogues
Docetaxel will be administered at a dose of 75 mg/m2 per square meter as a 1-hour intravenous infusion on day 1 every 21 days in association to 5 mg of prednisone orally twice daily. In patients randomised to arms A up to 10 cycles of docetaxel will be planned in association to maintenance of LH-RH analogues administration.
(Experimental)
Ten Docetaxel cycles + stop androgen deprivation therapy
docetaxel
Docetaxel will be administered at a dose of 75 mg/m2 per square meter as a 1-hour intravenous infusion on day 1 every 21 days in association to 5 mg of prednisone orally twice daily. In patients randomised to arms B up to 10 cycles of docetaxel will be planned, in association to stopping LH-RH analogues.
(Experimental)
Intermittent Docetaxel
docetaxel
Patients randomised in the arms AB1 (intermittent docetaxel) will suspend treatment after at least 4 cycles if their PSA level will be reduced >50%. Docetaxel treatment will be resumed when the serum PSA will rise by >50% from the lowest PSA level recorded and will be >10 ng/mL or when there will be other evidence of disease progression. PSA progression must to be confirmed with a second assessment after 2 weeks before deciding to resume docetaxel administration.
(Active Comparator)
Continuous Docetaxel
continuous docetaxel
Patients randomised in the arms AB2 (continuous docetaxel) will continue treatment up to ten cycles after even if their PSA level at 4 cycles will be reduced >50% or will reach a level <4 ng/mL.
continuous docetaxel
Patients randomised in the arms AB1(intermittent docetaxel) will continue treatment up to ten cycles even if their PSA level after 4 cycles will be reduced >50% or will reach a level <4 ng/mL.

Primary Outcomes

Measure
overall survival
time frame: six years

Secondary Outcomes

Measure
Toxicity
time frame: six years
Progression free survival
time frame: six years
Quality of life
time frame: six years
Pain
time frame: six years
Cost Analysis
time frame: six years

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: 1. age over 18 years, 2. histologically documented adenocarcinoma of the prostate, 3. written informed consent to the study, 4. 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, 5. an elevated PSA level must have been documented within 4 weeks of initiating docetaxel chemotherapy, 6. more than 4 weeks since major surgery and fully recovered, 7. more than 4 weeks since any prior radiation with any toxicity attributable to radiation resolved to grade 1 or less, 8. more than 8 weeks since the last dose of strontium or samarium, 9. ECOG Performance Status more than/equal to 2, 10. life expectancy >6 months, 11. 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). 12. Appropriate patient compliance Exclusion Criteria: 1. Patients with increased serum PSA levels with negative bone scan and CT scan. 2. 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, 3. Peripheral neuropathy >grade 1, 4. 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, 5. patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80, 6. poorly controlled diabetes (fasting blood glucose >250) despite optimization of medical therapy, peptic ulcers or other contraindications to steroid therapy, 7. previous history of malignant disease with the exception of non melanoma skin cancer curatively treated, 8. significant neurologic or psychiatric diseases preventing patients to give a valid informed consent, 9. brain metastases, 10. prisoner status 11. 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. -

Additional Information

Official title Androgen Deprivation Withdrawal Versus Maintenance and Intermittent Chemotherapy Versus Continuous in Prostate Cancer Patients With Castrate Resistant Disease
Principal investigator Marcello Tucci, MD
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 includes a double randomizzzazione aims generally demonstrating non-inferiority in terms of survival of the suspension dell'ormonoterapia versus the maintenance and / or administration of intermittent versus continuous administration of chemotherapy in patients with prostate cancer resistant to chemical castration I started to line chemotherapy with Docetaxel.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by University of Turin, Italy.