- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00243646
Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In calender year 2005, 220, 000 men will be diagnosed with prostate cancer and approximately 30,000 will subsequently die of metastatic disease. Although the vast majority of men will be diagnosed with clinically localized and potentially curable disease, the selection of one local modality over another remains a focus of significant controversy within the uro-oncology community. However, patients with higher risk features are most often managed with radiotherapeutic approaches to include androgen deprivation therapy.
Prostate brachytherapy represents the ultimate-three dimensional conformal therapy and permits dose escalation far exceeding other modalities. Following permanent prostate brachytherapy with or without supplemental external beam radiation therapy, favorable long-term biochemical outcomes have been reported for patients with low, intermediate and high risk features with a morbidity profile that compares favorably with competing local modalities (1,2).
Several prospective randomized trials have demonstrated that androgen deprivation therapy in conjunction with conventional doses of external beam radiation therapy (65-70 Gy)results in improvement in disease-free and overall survival in patients with locally advanced prostate cancer (3,4).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98104
- Seattle Prostate Institute
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Seattle, Washington, Estados Unidos, 98108
- Groupe Health Cooperative, Veterans Adminstration Hospital and University of Washington
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West Virginia
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Wheeling, West Virginia, Estados Unidos, 26003
- Schiffler Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- High risk patients - Two to three of the following: PSA 10-30 ng/mL, Gleason score greater than or equal to 6, clinical stage greater than or equal to T2c (2002 ACJJ).
- CT of the abdomen and pelvis and bone scan without evidence of metastases.
- An enzymatic prostatic acid phosphatase must be obtained prior to randomization.
- A serum testosterone must be obtained prior to initiation of androgen deprivation therapy.
- No prior pelvic external beam radiation therapy for prostate cancer or other malignancies.
- No prior androgen deprivation therapy.
- Minimum 5 year life expectancy.
- No other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years.
Exclusion Criteria:
- Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: no hormones
All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with no hormones
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All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant
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Comparador activo: 9 months of hormone therapy
All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with a 9 month course of hormone therapy
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All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant
9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).
9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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PSA 3 and 6 months following implantation then every 6 months.
Periodo de tiempo: 3 and 6 months following implantation then every 6 months
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PSA 3 and 6 months following implantation then every 6 months.
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3 and 6 months following implantation then every 6 months
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Serum testosterone levels at 3 and 6 months in hormonally manipulated patients.
Periodo de tiempo: 3 and 6 months
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Serum testosterone levels at 3 and 6 months in hormonally manipulated patients
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3 and 6 months
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Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected.
Periodo de tiempo: as needed
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Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected.
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as needed
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
EPIC on 6 and 12 months and then annually.
Periodo de tiempo: 6 and 12 months and then annually.
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EPIC on 6 and 12 months and then annually.
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6 and 12 months and then annually.
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Hormonally manipulated patients will obtain a DEXA scan.
Periodo de tiempo: as needed
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Hormonally manipulated patients will obtain a DEXA scan.
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as needed
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For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended.
Periodo de tiempo: every 3 months is recommended.
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For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended.
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every 3 months is recommended.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gregory S Merrick, MD, Schiffler Cancer Center, Wheeling, WV
- Silla de estudio: Kent E. Wallner, MD, Group Health Cooperative, Veterans Administration Hospital, and University of Washington
- Silla de estudio: John Sylvester, MD, Seattle Prostate Institute Seattle, WA 98104
Publicaciones y enlaces útiles
Publicaciones Generales
- Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000 Dec 20;56(6):899-905. doi: 10.1016/s0090-4295(00)00858-x.
- D'Amico AV, Manola J, Loffredo M, Renshaw AA, DellaCroce A, Kantoff PW. 6-month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized prostate cancer: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):821-7. doi: 10.1001/jama.292.7.821.
- Wallner K, Merrick G, True L, Sutlief S, Cavanagh W, Butler W. 125I versus 103Pd for low-risk prostate cancer: preliminary PSA outcomes from a prospective randomized multicenter trial. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1297-303. doi: 10.1016/s0360-3016(03)01448-2.
- Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4.
- Crook J, Ludgate C, Malone S, Lim J, Perry G, Eapen L, Bowen J, Robertson S, Lockwood G. Report of a multicenter Canadian phase III randomized trial of 3 months vs. 8 months neoadjuvant androgen deprivation before standard-dose radiotherapy for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2004 Sep 1;60(1):15-23. doi: 10.1016/j.ijrobp.2004.02.022.
- Roach M 3rd, DeSilvio M, Lawton C, Uhl V, Machtay M, Seider MJ, Rotman M, Jones C, Asbell SO, Valicenti RK, Han S, Thomas CR Jr, Shipley WS; Radiation Therapy Oncology Group 9413. Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol. 2003 May 15;21(10):1904-11. doi: 10.1200/JCO.2003.05.004.
- Merrick GS, Wallner KE, Butler WM. Permanent interstitial brachytherapy for the management of carcinoma of the prostate gland. J Urol. 2003 May;169(5):1643-52. doi: 10.1097/01.ju.0000035544.25483.61.
- Merrick GS, Butler WM. Modified uniform seed loading for prostate brachytherapy: rationale, design, and evaluation. Tech Urol. 2000 Jun;6(2):78-84.
- Consensus statement: guidelines for PSA following radiation therapy. American Society for Therapeutic Radiology and Oncology Consensus Panel. Int J Radiat Oncol Biol Phys. 1997 Mar 15;37(5):1035-41. No abstract available.
- Pilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D. Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31. J Clin Oncol. 1997 Mar;15(3):1013-21. doi: 10.1200/JCO.1997.15.3.1013.
- Merrick GS, Butler WM, Galbreath RW, Lief JH, Adamovich E. Does hormonal manipulation in conjunction with permanent interstitial brachytherapy, with or without supplemental external beam irradiation, improve the biochemical outcome for men with intermediate or high-risk prostate cancer? BJU Int. 2003 Jan;91(1):23-9. doi: 10.1046/j.1464-410x.2003.04024.x.
- Merrick GS, Butler WM, Wallner KE, Galbreath RW, Lief JH, Allen Z, Adamovich E. Impact of supplemental external beam radiotherapy and/or androgen deprivation therapy on biochemical outcome after permanent prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):32-43. doi: 10.1016/j.ijrobp.2004.05.003.
- Lee LN, Stock RG, Stone NN. Role of hormonal therapy in the management of intermediate- to high-risk prostate cancer treated with permanent radioactive seed implantation. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):444-52. doi: 10.1016/s0360-3016(01)02598-6.
- Stock RG, Cahlon O, Cesaretti JA, Kollmeier MA, Stone NN. Combined modality treatment in the management of high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2004 Aug 1;59(5):1352-9. doi: 10.1016/j.ijrobp.2004.01.023.
- Sylvester J, Blasko JC, Grimm PD, Meier R, Goy B, Colburn G, Cavanagh W. Neoadjuvant Androgen Ablation Combined with External-Beam Radiation Therapy and Permanent Interstitial Brachytherapy Boost in Localized Prostate Cancer. Mol Urol. 1999;3(3):231-236.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias Genitales Masculinas
- Enfermedades prostáticas
- Neoplasias prostáticas
- Efectos fisiológicos de las drogas
- Agentes antineoplásicos
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Antagonistas de hormonas
- Antagonistas de andrógenos
- Bicalutamida
Otros números de identificación del estudio
- 05-8-4
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