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Efficacy Study Evaluating Chemotherapy in Prostate Cancer (SensiCab)

3 mai 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

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 .

Type d'étude

Interventionnel

Inscription (Anticipé)

400

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Suède
      • Örebro, Suède, 70185
        • Recrutement
        • University Hospital of Örebro
        • Contact:
        • Chercheur principal:
          • Ove Andren, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: Cabazitaxel + Androgen deprivation therapy
Cabazitaxel + LHRH agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device.
Autres noms:
  • Jevtana-Leuporelin
Comparateur actif: Arm B:
-Hormone: LHRH agonist antiandrogens for 30 days + OR surgical castration OR CAB complete androgen blockade by LHRH agonist + antiandrogen device.
Médicament: Androgen deprivation therapy
LHRH agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device.
Autres noms:
  • Leuporelin

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Overall survival
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Progression free survival
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Örebro University, Sweden

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 novembre 2012

Achèvement primaire (Anticipé)

1 novembre 2018

Achèvement de l'étude (Anticipé)

1 novembre 2019

Dates d'inscription aux études

Première soumission

14 février 2013

Première soumission répondant aux critères de contrôle qualité

1 novembre 2013

Première publication (Estimation)

8 novembre 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

4 mai 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 mai 2016

Dernière vérification

1 mai 2016

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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