A Prospective Phase II Study of Preoperative, Controlled Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis
40 Years
N/A
Male
Prostate Cancer
Trial Information
A Prospective Phase II Study of Preoperative, Controlled Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis
OBJECTIVES:
Primary
- Compare the effect of neoadjuvant exisulind vs no neoadjuvant treatment on apoptosis in
patients with stage II or III prostate cancer undergoing radical prostatectomy.
Secondary
- Determine the effect of this drug (preoperatively) on surrogate endpoint biomarkers
(i.e., prostate-specific antigen, high-grade prostatic intraepithelial neoplasia,
MIB-1, and DNA ploidy) in these patients.
OUTLINE: This is a nonrandomized, controlled study. Patients are assigned to 1 of 2 groups
based on the treating physician.
- Control group: Patients undergo radical prostatectomy only.
- Treatment group: Patients receive oral exisulind once daily for 4 weeks. Patients then
undergo radical prostatectomy.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 130 patients (65 per group) will be accrued for this study
within approximately 10-12 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Clinical stage T1c-3b, N0-X, M0
- Gleason score ≥ 6
- Planning to undergo pelvic lymphadenectomy and radical prostatectomy at Mayo Clinic
Rochester
- Interval from biopsy to prostatectomy is at least 4, but no more than 14, weeks
- Selected patients of Dr. R. P. Myers who are undergoing prostatectomy during the
enrollment period will be assigned to the control group* NOTE: *Additional
historical controls may be selected from Dr. Myers' patients who underwent
prostatectomy within the past 4 years
PATIENT CHARACTERISTICS:
Age
- 40 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- ALT normal (10-45 U/L)
- AST normal (12-31 U/L)
- Alkaline phosphatase normal (119-309 U/L)
- Bilirubin normal (0.1-1.0 mg/dL)
- No history of hepatitis, cirrhosis, or other hepatic dysfunction
Renal
- Creatinine < 1.5 mg/dL
Other
- Fertile patients must use effective contraception
- No hypersensitivity to sulindac (treatment group)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- No prior ablation (treatment group)
- No prior hormone replacement or antiandrogen therapy (e.g., testosterone,
diethylstilbestrol, leuprolide, goserelin, flutamide, bicalutamide, finasteride,
nilutamide, or megestrol)
- No concurrent antiandrogen therapy, luteinizing hormone-releasing hormone agonists,
finasteride, or diethylstilbestrol
Radiotherapy
- No prior pelvic radiotherapy
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
Other
- No prior treatment for prostate cancer before prostatectomy (control group)
- No concurrent cyclooxygenase-2 inhibitors
- No concurrent sulindac
- No concurrent nonsteroidal anti-inflammatory drugs except low-dose (no more than 325
mg/day) aspirin for cardiovascular prophylaxis
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Apoptosis 4 weeks after completion of study as assessed by marker analysis (bcl-2, Bax, Par-4, M30, TUNEL assay, PTEN)
Safety Issue:
No
Principal Investigator
Bradley C. Leibovich, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000353196
NCT ID:
NCT00078910
Start Date:
August 2003
Completion Date:
September 2006
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
