A Prospective Phase II Study of Preoperative, Controlled Exisulind Therapy Initiated Prior to Radical Prostatectomy: Effect on Apoptosis
Colección de datos
Enfermedades Urogenitales+6
+ Enfermedades Genitales
+ Enfermedades Genitales Masculinas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de agosto de 2003
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 130 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Hombre
Sexo biológico de los participantes elegibles para inscribirse.A partir de 40 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 3 ubicaciones
Mayo Clinic - Jacksonville
Jacksonville, United StatesMayo Clinic Cancer Center
Rochester, United States