A Prospective Phase II Study of Preoperative, Controlled Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis
Data Collection
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: August 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.130 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Mayo Clinic - Jacksonville
Jacksonville, United StatesMayo Clinic Cancer Center
Rochester, United States