Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
|Prostate Adenocarcinoma Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer||Drug: Goserelin Acetate Other: Laboratory Biomarker Analysis Drug: Leuprolide Acetate Other: Quality-of-Life Assessment||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Temporary Androgen Deprivation Therapy in High Risk Prostate Cancer Following Radical Prostatectomy|
- Biochemical Progression-free Survival Rate [ Time Frame: 2 years ]
- Biochemical Progression-free Survival (BPFS), Overall Survival (OS), and Prostate Cancer Specific Survival (PCS)
- Toxicity as Per NCI CTCAE Version 3
- Quality of Life as Assessed by the FACT-P and LASA Tool Within and Between the Two Treatment Arms [ Time Frame: Baseline and months 3, 6, 9, 12, 15, 18, 21, and 24 ]
- Measurements of Serum and Urine Biomarkers, and Comparison Between the Two Arms
- Correlation of Circulating Tumor Cells or Circulating Endothelial Cells Following Study Treatments With Biochemical Progression-free Survival Rate
- Evaluation of Prognostic and Predictive Tissue Based Biomarkers (CTCs, CECs)
|Study Start Date:||July 2009|
|Study Completion Date:||July 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm A (antihormone therapy)
Patients receive leuprolide acetate IM on day 1 OR goserelin acetate SC on day 1. Courses repeat every 3 months for 9 months in the absence of disease progression or unacceptable toxicity.
Drug: Goserelin Acetate
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesDrug: Leuprolide Acetate
Other Names:Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
No Intervention: Arm B (no antihormone therapy)
Patients undergo observation every 3 months for 9 months.
I. To compare the difference in the biochemical progression-free survival rate (bPFS) at 2-years between immediate androgen deprivation therapy (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 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 Functional Assessment of Cancer Therapy-Prostate (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.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1. Courses repeat every 3 months for 9 months 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 up every three months for 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937768
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Robert Karnes||Mayo Clinic|