Status:
UNKNOWN
Androgen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer
Lead Sponsor:
A.O.U. San Giovanni Battista di Torino, Italy
Conditions:
Pain
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work i...
Detailed Description
OBJECTIVES: Primary * Compare the 2-year progression-free survival rate (biological progression and/or clinical progression) in patients with advanced prostate cancer treated with androgen ablation ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Meets one of the following criteria
- Metastatic disease
- Systemic progressive disease after locoregional therapy (surgery or radiotherapy)
- No metastatic disease AND meets one of the following criteria:
- Circulating PSA levels ≥ 50 ng/mL (confirmed by ≥ 2 subsequent evaluations)
- Biochemical progression with a PSA doubling time \< 6 months (with ≥ 3 measurements taken 1 month apart) after primary locoregional treatment (radical prostatectomy or radiotherapy) with curative intent
- Prostate-confined tumor with high-risk features whose therapy of choice is androgen deprivation
- No symptomatic brain metastases or leptomeningeal disease
- PATIENT CHARACTERISTICS:
- ECOG or Zubrod performance status 0-2
- Life expectancy ≥ 6 months
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- Bilirubin ≤ 2.0 mg/dL
- AST/ALT ≤ 1.5 times upper limit of normal
- Creatinine ≤ 1.5 mg/dL
- No active infection requiring IV antibiotics
- No active ulcer, unstable diabetes mellitus, or other contraindication to corticotherapy
- None of the following cardiovascular conditions:
- Uncompensated heart failure (ejection fraction \< 40%)
- Myocardial infarction or revascularization procedure within the past 6 months
- Unstable angina pectoris
- Uncontrolled cardiac arrhythmia
- No other severe clinical condition that, in the judgment of the local investigator, would place the patient at undue risk or interfere with the study
- Not a prisoner
- No prior malignancy, except for non-melanoma skin cancer, in situ cervical carcinoma, or other cancer that was curatively treated with no evidence of disease for ≥ 5 years
- No familial, social, or geographical condition or significant neurologic or psychiatric disorder that would preclude understanding or rendering informed consent or fully complying with study treatment and follow-up
- PRIOR CONCURRENT THERAPY:
- At least 5 years since prior radiotherapy outside the prostate
- Prior hormonal therapy allowed provided it was administered for ≤ 6 months
- At least 12 months since prior hormonal therapy
- More than 30 days since prior participation in another clinical trial involving investigational agents
- No prior surgical castration
- Concurrent androgen deprivation for prostate cancer allowed provided it was started ≤ 3 months prior to initiation of study treatment
- Concurrent anticoagulant treatment allowed
- No other concurrent investigational drugs
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00796458
Start Date
April 1 2005
Last Update
August 12 2013
Active Locations (1)
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1
Rete Oncologica Piemontese - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
Turin, Italy, 10126