Finding studies
Finding studies
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Lead
ECOG-ACRIN Cancer Research Group
With
OBJECTIVES: Primary * Evaluate the ability of early chemotherapy to improve overall survival of patients commencing androgen deprivation for metastatic prostate cancer. Secondary * Determine whether early chemotherapy can increase the time to clinical progression (radiographic or symptomatic deterioration due to disease) over hormonal therapy alone. * Determine whether early chemotherapy can increase the time to development of hormone-refractory disease over hormonal therapy alone. * Determine whether early chemotherapy can increase the time to serological progression over hormonal therapy alone. * Determine rates of biochemical response at 6 months and 12 months in the chemohormonal arm versus the hormonal therapy alone arm. * Determine the frequency of adverse events and the tolerability of chemotherapy combined with hormonal therapy versus hormonal therapy alone. * Determine whether the postulated clinically meaningful increase in disease control is associated with an alteration in overall quality of life using the Functional Assessment of Cancer Therapy-Prostate questionnaire. * Determine the ability of prostate-specific antigen (PSA) changes to be a surrogate for clinical benefit from therapy and overall survival. Tertiary * Determine whether there are proteins differentially translated from the genome in hormone-sensitive prostate cancer, prostate cancer that has responded to hormonal therapy, and hormone-refractory prostate cancer. * Determine the frequency of constitutive polymorphisms of enzymes involved in steroid metabolism and other carcinogenic processes. * Determine whether the amount and frequency of certain carcinogenic proteins in prostate cancer tissue such as C-X-C chemokine receptor type 4 (CXCR-4) and manganese superoxide dismutase can be correlated with a poor prognosis. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (≥ 70 vs \< 70), ECOG performance status (0-1 vs 2), combined androgen blockade for \> 30 days (yes vs no), duration of prior adjuvant hormonal therapy (\> 12 months vs ≤ 12 months), concurrent bisphosphonate use (yes vs no), and volume of disease (low vs high). Patients are randomized to 1 of 2 treatment arms. * Arm A (Androgen-Deprivation Therapy and Docetaxel): Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone \[LHRH\] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel intravenously (IV) over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. * Arm B (Androgen-Deprivation Therapy alone): Patients receive androgen-deprivation therapy (as in arm A) alone. Quality of life is assessed at baseline and at months 3, 6, 9 and 12. After completion of study treatment, patients are followed up periodically for up to 10 years.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
