Phase III Study of Chemo-Hormonal Therapy Versus Hormonal Therapy Alone in Advanced Hormone-Naives Prostate Cancer Patients.
- Compare the 2-year progression-free survival rate (biological progression and/or
clinical progression) in patients with advanced prostate cancer treated with androgen
ablation with vs without docetaxel.
- Compare the overall survival of patients treated with these regimens.
- Compare the time to treatment failure in patients treated with these regimens.
- Compare the toxicity profiles of these regimens in these patients.
- Compare the PSA response rate in patients treated with these regimens.
- Compare the response rate in patients with measurable disease treated with these
- Compare the percentage of patients who undergo PSA normalization.
- Compare the quality of life of patients treated with these regimens.
- Compare the efficacy of these regimens in controlling bone pain in these patients.
- Compare the changes in chromogranin A levels in patients treated with these regimens.
- Compare the total cost of care of patients treated with these regimens.
OUTLINE: This is a multicenter study.
Patients receive luteinizing hormone-releasing hormone analogue (LHRH-A) therapy for 6
months. Patients also receive antiandrogen therapy during the first 5 weeks of LHRH-A
therapy. After 6 months of LHRH-A therapy, patients with PSA response are randomized to 1 of
2 treatment arms.
- Arm I: Patients continue to receive LHRH-A therapy until disease progression.
- Arm II:Patients receive LHRH-A therapy as in arm I. Patients also receive docetaxel IV
on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses in the
absence of disease progression or unacceptable toxicity.
Patients complete questionnaires during treatment to assess bone pain. Quality of life is
After completion to study therapy, patients are followed for ≥ 2 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
2-year progression-free survival rate
Oscar Bertetto, MD
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino