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Efficacy Study Evaluating Chemotherapy in Prostate Cancer (SensiCab)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01978873
Recruitment Status : Unknown
Verified May 2016 by Ove Andrén, Örebro University, Sweden.
Recruitment status was:  Recruiting
First Posted : November 8, 2013
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Ove Andrén, Örebro University, Sweden

Tracking Information
First Submitted Date  ICMJE February 14, 2013
First Posted Date  ICMJE November 8, 2013
Last Update Posted Date May 4, 2016
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2013)
Overall survival [ Time Frame: From date of randomization until date of death from any cause, assessed up to 7 years. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2013)
  • Progression free survival [ Time Frame: 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.
  • PSA response [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study Evaluating Chemotherapy in Prostate Cancer
Official Title  ICMJE Randomized Phase III Trial Comparing Cabazitaxel Combination Hormone Therapy to Hormone Therapy Alone in Metastatic Prostate Cancer or High Risk Disease
Brief Summary

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.

Detailed Description

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 .

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Cabazitaxel + Androgen deprivation therapy
    Cabazitaxel + LHRH agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device.
    Other Name: Jevtana-Leuporelin
  • Drug: Androgen deprivation therapy
    LHRH agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device.
    Other Name: Leuporelin
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Cabazitaxel + Androgen deprivation therapy
  • Active Comparator: Arm B:
    -Hormone: LHRH agonist antiandrogens for 30 days + OR surgical castration OR CAB complete androgen blockade by LHRH agonist + antiandrogen device.
    Intervention: Drug: Androgen deprivation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 1, 2013)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01978873
Other Study ID Numbers  ICMJE 2011-0030-78-10
2011-003078-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All data from the main study will be made public available after the publication of the study.
Responsible Party Ove Andrén, Örebro University, Sweden
Study Sponsor  ICMJE Örebro University, Sweden
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ove Andrén, Ass Prof. University Hospital Örebro
Principal Investigator: Marie Hjelm-Eriksson, MD Karolinska University Hospital
PRS Account Örebro University, Sweden
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP