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Efficacy Study Evaluating Chemotherapy in Prostate Cancer (SensiCab)

3 de mayo de 2016 actualizado por: Ove Andrén, Örebro University, Sweden

Randomized Phase III Trial Comparing Cabazitaxel Combination Hormone Therapy to Hormone Therapy Alone in Metastatic Prostate Cancer or High Risk Disease

This clinical trial is designed on the basis of an unmet clinical need, as well as other factors including: 1) the ability to identify subjects at high risk of dying early from their disease, 2) the fact that hormonal therapy has already been shown to improve survival when applied early in the natural history, 3) the availability of chemotherapy such as cabazitaxel that can improve survival in subjects with advanced disease and 4) that chemotherapy (docetaxel) given concomitant with hormone treatment has proven to prolong time to progression.

It is the investigators hypothesis that a more appropriate group of patients who may benefit from the curative potential of systemic chemo-hormonal modality is that with minimal, but detectable disease who have a high probability of developing metastatic disease, clinical symptoms and eventually death from prostate cancer in a defined time frame. The investigators hypothesize further that the approach is likely to be more effective at a time of minimal tumour burden, resulting in minimization of the overall burden of therapy and better quality of life while on treatment.

This trial will determine whether any benefit is gained by adding chemotherapy before hormonal therapy to hormonal therapy alone in the population of subjects with metastatic or high risk disease.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

This clinical trial is designed on the basis of an unmet clinical need, as well as other factors including: 1) the ability to identify subjects at high risk of dying early from their disease, 2) the fact that hormonal therapy has already been shown to improve survival when applied early in the natural history, 3) the availability of chemotherapy such as cabazitaxel that can improve survival in subjects with advanced disease and 4) that chemotherapy (docetaxel) given concomitant with hormone treatment has proven to prolong time to progression.

It is the investigators hypothesis that a more appropriate group of patients who may benefit from the curative potential of systemic chemo-hormonal modality is that with minimal, but detectable disease who have a high probability of developing metastatic disease, clinical symptoms and eventually death from prostate cancer in a defined time frame. The investigators hypothesize further that the approach is likely to be more effective at a time of minimal tumour burden, resulting in minimization of the overall burden of therapy and better quality of life while on treatment.

This trial will determine whether any benefit is gained by adding chemotherapy before hormonal therapy to hormonal therapy alone in the population of subjects with metastatic or high risk disease. Two therapeutic approaches will be compared in this two-arm randomized clinical trial. The control Arm A provides hormonal therapy alone. The experimental Arm B involves treatment with hormone therapy + Cabazitaxel 25 mg / m² / day on day 1 every 3 weeks continued if the patient has stable or responding disease up to 10 cycles. For the schematic representation of study design please see Section 7.3.1.

Subjects with primary metastatic or N+ or high risk disease (PSA>100) will be eligible. The primary endpoint of the trial is overall survival.

Based on the yearly number of prostate cancer patients who are diagnosed with metastatic or high risk disease, approximately 1200 men per year (if +15% improvement)are potential candidates for this approach in the Scandinavian countries .

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

400

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Suecia
      • Örebro, Suecia, 70185
        • Reclutamiento
        • University Hospital of Örebro
        • Contacto:
        • Investigador principal:
          • Ove Andren, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Masculino

Descripción

Inclusion Criteria:

  • Histological or cytological confirmed prostate adenocarcinoma Metastatic PC (Prostate cancer) with measurable or evaluable disease or High risk PC (PSA > 100) or Node positive disease (N+)
  • No prior treatment for prostate cancer (including bisfosfonate)
  • Age above 18 years
  • ECOG 0- 2
  • Estimated survival > 3 months
  • WBC 2000 / mm 3, neutrophils ≥1500 / mm 3, platelets 100,000 / mm 3
  • Satisfactory liver function: bilirubin, transaminases ≤ 1.5 times the upper limit of normal.
  • Satisfactory renal function. Serum creatinine <1.5 x ULN (150 mmol/l). If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance >60 mL/min are accepted in the study. https://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfr
  • Patient information and signature of informed consent

Exclusion Criteria:

  • Cardiovascular disease (severe symptomatic coronary artery disease, congenital heart failure, class 3 and 4 of the NYHA)
  • Severe peripheral neuropathy
  • Active infection or other serious underlying pathology that could prevent patients from receiving treatment
  • History of cancer within 5 years before inclusion in the study other than basal cell or squamous cell skin cancer adequately treated
  • Brain metastases, uncontrolled symptomatic or asymptomatic
  • Patient participating in another clinical trial protocol with a molecule during this experimental study or treated four weeks prior to randomization.
  • Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B)
  • Systemic treatment with high dose steroids
  • Any severe acute or chronic medical condition which would impair the ability of the patient to participate to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures.
  • History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Experimental: Arm A:
  • Cabazitaxel 25 mg / m² / day on day 1 every 3 weeks continued if the patient has stable disease or responding to up to 10 cycles. Cabazitaxel will be administered in combination with oral prednisone or prednisolone (Prednisolon 10mg 1x1)
  • Hormones will be initiated in conjunction with the last cycle of chemotherapy. Consists of the administration of a luteinizing hormone-releasing hormone (LHRH) agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device. G-CSF treatment according to ASCO guidelines is recommended.
Droga: Cabazitaxel + Androgen deprivation therapy
Cabazitaxel + LHRH agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device.
Otros nombres:
  • Jevtana-Leuporelin
Comparador activo: Arm B:
-Hormone: LHRH agonist antiandrogens for 30 days + OR surgical castration OR CAB complete androgen blockade by LHRH agonist + antiandrogen device.
Droga: Androgen deprivation therapy
LHRH agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device.
Otros nombres:
  • Leuporelin

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Overall survival
Periodo de tiempo: From date of randomization until date of death from any cause, assessed up to 7 years.
From date of randomization until date of death from any cause, assessed up to 7 years.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression free survival
Periodo de tiempo: From date of randomization until progression, assessed up to 3 years.
Ct and bonescan at three and six months and then at progession. PSA assesments every three moths during the first year and then every six months until progression.
From date of randomization until progression, assessed up to 3 years.
PSA response
Periodo de tiempo: From date of randomization up to 7 years.
Assements every three months during the first year. Then every six months until progression. Then after progression every 12 months.
From date of randomization up to 7 years.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Örebro University, Sweden

Investigadores

  • Investigador principal: Ove Andrén, Ass Prof., University hospital Örebro
  • Investigador principal: Marie Hjelm-Eriksson, MD, Karolinska University Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de noviembre de 2012

Finalización primaria (Anticipado)

1 de noviembre de 2018

Finalización del estudio (Anticipado)

1 de noviembre de 2019

Fechas de registro del estudio

Enviado por primera vez

14 de febrero de 2013

Primero enviado que cumplió con los criterios de control de calidad

1 de noviembre de 2013

Publicado por primera vez (Estimar)

8 de noviembre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

4 de mayo de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

3 de mayo de 2016

Última verificación

1 de mayo de 2016

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2011-0030-78-10
  • 2011-003078-10 (Número EudraCT)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

All data from the main study will be made public available after the publication of the study.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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