Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Eastern Cooperative Oncology Group
With
OBJECTIVES: Primary * To compare the two regimens on the proportion of patients with undetectable prostate-specific antigen (PSA) level (\< 0.2 ng/mL) at 44 weeks. Secondary * To assess the proportion of patients with PSA decline \> 85% at 44 weeks on the combination therapy arm compared to that of bicalutamide monotherapy arm. * To assess the distribution of best PSA response in each study arm. * To assess the time to PSA progression and the time to PSA nadir in each arm of the study. * To assess the duration of PSA response in each arm of the study. * To characterize the PSA slope before, during, and after treatment. * To evaluate the safety and tolerability of enzastaurin hydrochloride in this patient population. * To determine whether Gleason score or prior hormonal therapy has any effect on PSA response to treatment. OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≤ 6 vs 7 vs 8-10) and prior hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm A: * Weeks 1-12: Patients are observed without treatment. Patients with a prostate-specific antigen (PSA) rise of \> 50% above baseline or nadir (whichever is lowest) and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, may be started on bicalutamide before the end of week 12 at the discretion of the treating physician. * Weeks 13-44: Patients with a rise PSA ≥ 50% above baseline or nadir, and a PSA rise of at least 5 ng/mL confirmed by a repeat PSA at least 2 weeks later, are removed from study. Patients receive oral bicalutamide once daily. Patients achieving a PSA decline ≥ 50% in the absence of toxicity may continue to receive bicalutamide up to 72 weeks. * Arm B: * Weeks 1-12: Patients receive oral enzastaurin hydrochloride twice daily. Patients with a PSA rise of \> 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, may be started on bicalutamide before the end of week 12 at the discretion of the treating physician. * Weeks 13-44: Patients with a PSA rise of ≥ 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, are removed from study. Patients receive oral enzastaurin twice daily and oral bicalutamide once daily. Patients achieving a PSA decline ≥ 50% in the absence of toxicity may continue on this combination therapy up to 72 weeks. After completion of study treatment, patients are followed every 3 months for 5 years, and then every 6 months for up to 10 years.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
