Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III
bicalutamide
+ goserelin acetate
+ bicalutamide
Enfermedades Urogenitales+6
+ Enfermedades Genitales
+ Enfermedades Genitales Masculinas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 1995
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary Compare the survival of patients with metastatic stage IV prostate cancer responsive to combined androgen-deprivation therapy (CAD) treated with intermittent vs continuous CAD. Compare the effects of these treatment regimens on impotence, libido, and vitality/fatigue as well as the physical and emotional well-being of these patients. Secondary Compare general symptoms, role functioning, global perception of quality of life, and social functioning of patients treated with these regimens. Assess prostate-specific antigen (PSA) levels after continuous CAD administered before randomization and evaluate PSA changes throughout randomized treatment of these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to SWOG performance status (0-1 vs 2), severity of disease (minimal vs extensive), and prior hormonal therapy (neoadjuvant hormonal therapy vs finasteride vs neither). Induction therapy: Patients receive combined androgen-deprivation (CAD) therapy comprising goserelin subcutaneously once a month and oral bicalutamide once daily for 8 courses (7 months). Consolidation therapy: Patients are randomized to 1 of 2 consolidation regimens. Arm I (continuous CAD therapy): Patients continue CAD therapy as in induction therapy. Treatment continues in the absence of disease progression. Arm II (intermittent CAD therapy): Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. Patients with rising PSA or progressive disease begin CAD therapy as in induction therapy. Patients whose PSA normalizes after 8 courses return to observation. Patients whose PSA does not normalize after 8 courses continue CAD therapy. Quality of life is assessed before induction therapy, at 3 months (before consolidation therapy), and then at 9 and 15 months. Patients are followed every 6-12 months for at least 10 years. PROJECTED ACCRUAL: Approximately 1,500 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 3040 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 18 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 or cytologically confirmed adenocarcinoma of the prostate Metastatic stage IV (stage D2) Any number of bone metastases by bone scan allowed Unequivocal visceral organ metastases (liver, brain, or lung) allowed No suspected second primary tumors unless metastases are histologically confirmed, including special stains (e.g., prostate specific antigen [PSA] and prostatic alkaline phosphatase [PAP]) For entry into late induction therapy: No more than 1 month from the beginning of antiandrogen therapy to the beginning of luteinizing hormone-releasing hormone (LHRH) agonist therapy No more than 6 months since initiation of current combined androgen-deprivation therapy (LHRH agonist and antiandrogen) The effectiveness of the current depot LHRH agonist would not extend beyond 8 months after initiation of combined androgen therapy PSA at least 5 ng/mL No acute spinal cord compression PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Recovered from any major infection No active medical illness that would preclude study or limit survival No other malignancy within the past 5 years except: Adequately treated basal cell or squamous cell skin cancer Adequately treated carcinoma in situ of the bladder Adequately treated other superficial cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biological response modifier therapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: See Disease Characteristics More than 1 year since any prior neoadjuvant or adjuvant hormonal therapy for a duration of no more than 4 months Single or combination therapy allowed More than 1 year since prior finasteride for prostate cancer for a duration of no more than 9 months (less than 6 months for benign prostatic hypertrophy) Prior or concurrent megestrol for hot flashes allowed No other concurrent hormonal therapy Radiotherapy: No concurrent radiotherapy other than palliation of painful bone metastases Surgery: No prior bilateral orchiectomy Recovered from any prior major surgery
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
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 14 ubicaciones
Tom Baker Cancer Centre - Calgary
Calgary, CanadaAbrir Tom Baker Cancer Centre - Calgary en Google MapsCross Cancer Institute at University of Alberta
Edmonton, CanadaUniversity of British Columbia
Vancouver, CanadaNova Scotia Cancer Centre
Halifax, Canada