Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin acetate and leuprolide acetate, may lessen the amount of androgens made by the body and thus control prostate cancer growth. Many times, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. However in some prostate cancers there is a chance that tumors can re-grow despite surgery based on certain high risk features.
PURPOSE: This phase II trial is studying the side effects and how well leuprolide acetate or goserelin acetate work compared to observation) in treating patients with high-risk prostate cancer who have undergone radical prostatectomy.
Drug: leuprolide acetate
Other: laboratory biomarker analysis
Other: quality-of-life assessment
Other: pharmacological study
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
- Biochemical Progression-free Survival (BPFS), Overall Survival (OS), and Prostate Cancer Specific Survival (PCS) [ Designated as safety issue: No ]
- Toxicity as Per NCI CTCAE Version 3 [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Measurements of Serum and Urine Biomarkers, and Comparison Between the Two Arms [ Designated as safety issue: No ]
- Correlation of Circulating Tumor Cells or Circulating Endothelial Cells Following Study Treatments With Biochemical Progression-free Survival Rate [ Designated as safety issue: No ]
- Evaluation of Prognostic and Predictive Tissue Based Biomarkers (CTCs, CECs) [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
Drug: leuprolide acetate
Other Names:Drug: goserelin
Other Names:Other: laboratory biomarker analysis
Correlative studyOther: quality-of-life assessment
Other Name: quality of life assessmentOther: pharmacological study
Other Name: pharmacological studies
No Intervention: Arm B
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 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937768
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Robert Karnes, M.D.||Mayo Clinic|