Intermittent Hormonal Therapy With Leuprorelin and Flutamide in the Treatment of Stage D2 or TxNxM1b,c
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
This study is aimed at evaluating the effects of intermittent hormonal treatment with
complete androgen suppression (Leuprorelin 3.75 milligram [mg] sustained release [SR] and
Flutamide) in patients presenting with stage D2 or Tx Nx M1 ≠ M1a metastatic prostrate
cancer, with a prostate specific antigen (PSA) level 5-fold higher than normal (PSA greater
than or equal to [≥] 20 nanogram per milliliter [ng/mL], as quantitated by the Hybritech
radioimmunoassay) and with a subsequent decline to normal (PSA less than [<] 4 ng/mL) during
the initial 6 months of induction treatment. The results will be compared with those obtained
after continuous hormonal therapy with complete androgen suppression.