Androgen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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 in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving androgen ablation therapy together with docetaxel is more effective than giving androgen ablation therapy alone in treating patients with advanced prostate cancer.

PURPOSE: This randomized phase III trial is studying androgen ablation and docetaxel to see how well they work compared with androgen ablation alone in treating patients with advanced prostate cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: A.O.U. San Giovanni Battista di Torino, Italy
• Treatments: Docetaxel; Hormones

Criteria

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