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Androgen Deprivation Withdrawal Versus Maintenance and Intermittent Chemotherapy Versus Continuous in Prostate Cancer Patients With Castrate Resistant Disease

Phase 3
18 Years
Open (Enrolling)
Advanced Prostate Cancer

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Trial Information

Androgen Deprivation Withdrawal Versus Maintenance and Intermittent Chemotherapy Versus Continuous in Prostate Cancer Patients With Castrate Resistant Disease

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

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.


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Description:

The primary aim of the study will be the demonstration of non inferiority in terms of overall survival of stopping androgen deprivation therapy (arm B) versus maintenance androgen deprivation therapy (arms A) and intermittent docetaxel therapy (arm AB1) versus continuous docetaxel therapy (arms AB2) up to ten cycles.

Outcome Time Frame:

six years

Safety Issue:


Principal Investigator

Alfredo Berruti, PHD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical Oncology - Hospital San Luigi Gonzaga Orbassano (TO) - Italy


Italy: The Italian Medicines Agency

Study ID:

EudraCT 2010-019004-24



Start Date:

April 2010

Completion Date:

April 2016

Related Keywords:

  • Advanced Prostate Cancer
  • Prostatic Neoplasms