Intermittent Hormonal Therapy With Leuprorelin and Flutamide in the Treatment of Stage D2 or TxNxM1b,c

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.

Timeline

Start

1996-12

Primary completion

2005-09

Completion

2008-12

Drugs

Indications