Phase II Trial of Temporary Androgen Deprivation Therapy in High Risk Prostate Cancer Following Radical Prostatectomy
I. To compare the difference in the biochemical progression-free survival rate (bPFS) at
2-years between immediate ADT for nine months in high risk prostate cancer patients
following radical prostatectomy and a similar high risk patient population followed without
initiation of immediate ADT treatment.
I. To determine the three year difference in bPFS, prostate cancer specific survival, and
overall survival between immediate ADT for nine months and observation for high risk
prostate cancer patients following radical prostatectomy. II. To evaluate the toxicity
profile and quality of life (QOL) measured by FACT-P and linear analogue self assessment
(LASA) between two treatment arms.
I. To explore if serum and urine biomarker(s) levels at study entry, 9 months, or 24 months
in the two treatment arms are correlated with biochemical progression-free survival rate.
II. To explore if > 5 circulating tumor cells (CTCs) or circulating endothelial cells (CECs)
following study treatments are associated with biochemical progression-free survival rate.
III. To explore the prognostic and predictive value of tissue based biomarkers in high risk
prostate cancer patients.
This is a randomized phase II study.
Patients are stratified according to pathological Gleason score (6-7 vs >=8) and baseline
PSA at diagnosis (<10 ng/mL vs >=10 ng/mL). Patients are randomized to 1 of 2 arms.
Arm A: Patients receive leuprolide acetate intramuscularly on day 1 OR goserelin acetate
subcutaneously on day 1. Treatment repeats every 3 months for a up to 3 courses in the
absence of disease progression or unacceptable toxicity.
Arm B: Patients undergo observation every 3 months for 9 months. After completion of study
treatment, patients are followed every three months for 2 years. PROJECTED ACCRUAL: A total
of 128 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Biochemical progression-free survival rate
Robert Karnes, M.D.
United States: Federal Government
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