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Cabazitaxel vs Abiraterone or Enzalutamide in Patients With Poor Prognosis Metastatic Castration-resistant Prostate Cancer

This study is currently recruiting participants.
Verified September 2016 by British Columbia Cancer Agency
Sponsor:
ClinicalTrials.gov Identifier:
NCT02254785
First Posted: October 2, 2014
Last Update Posted: March 3, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Sanofi
Ozmosis Research Inc.
Information provided by (Responsible Party):
British Columbia Cancer Agency
  Purpose

The purpose of this study is to assess and compare the clinical benefit rate in patients with metastatic castrate-resistant prostate cancer and poor prognostic factors treated with cabazitaxel or novel hormonal agents (abiraterone or enzalutamide) as initial therapy, to determine which treatment is most active in this population. Clinical benefit rate is defined as PSA or measurable radiological response of any duration or stable disease for > or equal to 12 weeks, in the absence of other indicators of progression.

There is option to cross-over onto the other arm if the patient progresses.


Condition Intervention Phase
Metastatic Castration-Resistant Prostatic Cancer Drug: cabazitaxel Drug: Abiraterone Drug: Enzalutamide 160mg daily (oral) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Multi-center Study of Cabazitaxel Versus Abiraterone or Enzalutamide in Poor Prognosis-metastatic Castration-resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • Clinical benefit rate [ Time Frame: 12 weeks or more ]
    To assess and compare the clinical benefit rate in patients with mCRPC and poor prognostic factors treated with cabazitaxel or novel hormonal agents (abiraterone or enzalutamide) as initial therapy, to determine which treatment is most active in this population. Clinical benefit rate is defined as PSA or measurable radiological response of any duration or stable disease for greater than or equal to 12 weeks, in the absence of other indicators of progression.


Secondary Outcome Measures:
  • Duration of treatment time to progression [ Time Frame: 12 weeks until disease progression ]
    To measure the treatment time before any type of progression (symptomatic, PSA, or radiological) between Arm A and Arm B

  • Progression Free Survival [ Time Frame: 12 weeks until disease progression ]
    To measure the progression-free survival of metastatic castration-resistant prostate cancer patients following treatment with cabazitaxel or abiraterone/enzalutamide as initial therapy.

  • Overall Survival [ Time Frame: 12 weeks until 2 years after last study visit ]
    To measure the overall survival of metastatic castration-resistant prostate cancer patients following treatment with cabazitaxel or abiraterone/enzalutamide as initial therapy.


Estimated Enrollment: 120
Study Start Date: October 2014
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabazitaxel Drug: cabazitaxel
Cabazitaxel 25mg/m2 intravenous every 3 weeks until disease progression
Other Name: Jevtana
Active Comparator: Abiraterone or enzalutamide Drug: Abiraterone
Abiraterone 1000mg daily (oral) until disease progression
Other Name: Zytiga
Drug: Enzalutamide 160mg daily (oral)
Enzalutamide 160mg daily (oral) until disease progression
Other Name: Xtandi

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological diagnosis of prostate adenocarcinoma.
  • Able and willing to provide informed consent and to comply with the study procedures
  • Age ≥18
  • Evidence of metastatic disease on a chest, abdominal, or pelvic CT scan and/or bone scan within 6 weeks of registration
  • Castration resistant disease defined as evidence of radiological and/or PSA progression despite castrate levels of testosterone (serum testosterone < 50 ng/dL (1.7 nmol/L)). For PSA progression, there must be at least 2 sequential rises at a minimum of 1-week intervals. The first PSA value must be ≥ 2. (Prostate Cancer Working Group 2 (PCWG2) criteria)
  • Poor prognosis disease as defined by any of the following:

the presence of liver metastases OR development of castration-resistance within 12 months of orchiectomy or commencement of LHRH antagonist/agonist for metastatic disease OR the presence of 4 or more of the following factors:

  • LDH > ULN
  • ECOG Performance status (PS) 2
  • visceral metastatic disease
  • serum albumin less than or equal to 4 g/dL
  • ALP > ULN
  • or < 36 months from commencement of initial androgen deprivation therapy to study enrollment
  • ECOG PS 0-2.
  • Adequate end-organ function within 14 days of registration:

Haemoglobin ≥ 90 g/L Neutrophils ≥ 1.5 x 109 /L Platelets ≥ 100 x 109/L AST < 1.5 x ULN ALT < 1.5 x ULN Bilirubin ≤ 1.0 x ULN (exceptions for Gilbert's syndrome) Creatinine ≤ 1.5 x ULN

  • At least 21 days have passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of ≤ 800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of randomization.
  • At least 21 days have passed since receiving any investigational agent at the time of registration.
  • At least 21 days have passed since major surgery.
  • Neuropathy ≤ grade 1 at the time of registration.
  • Has recovered from all therapy-related toxicity to ≤ grade 2 (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy) at the time of registration.
  • Eligible for abiraterone acetate and/or enzalutamide as per standard of care practices.

Exclusion Criteria:

  • Histologic evidence of small cell/neuroendocrine prostate cancer.
  • Other chemotherapy regimen beyond one prior course of docetaxel.
  • Previously received treatment with cabazitaxel.
  • Received any prior next-generation anti-androgen (e.g. enzalutamide, ARN-509) or CYP 17 inhibitors (e.g. abiraterone, TAK-700).
  • Other condition, illness, psychiatric condition, or laboratory abnormality that may increase the risk associated with administration of cabazitaxel, abiraterone or enzalutamide, study participation, or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254785


Contacts
Contact: Kim N Chi, MD 604-877-6000 ext 2734 kchi@bccancer.bc.ca

Locations
Australia, Victoria
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Contact: Carmel Pezaro       carmel.pezaro@monash.edu   
Monash Health-Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
Contact: Arun Azad, MBBS, PhD, FRACP    613-857-22860    arun.azad@monash.edu   
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Contact: Ben Tran       ben.tran@petermac.org   
Canada, Alberta
Tom Baker Cancer Cantre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Dean Ruether, MD    403-521-3093    Dean.Ruether@albertahealthservices.ca   
Principal Investigator: Dean Ruether, MD         
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Scott North, MD    780-432-8756    Scott.North@albertahealthservices.ca   
Principal Investigator: Scott North, MD         
Canada, British Columbia
BCCA - Kelowna Recruiting
Kelowna, British Columbia, Canada, V1Y 5J3
Contact: Deepa Wadhwa, MD    250-712-3990    Deepa.Wadhwa@bccancer.bc.ca   
Principal Investigator: Deepa Wadhwa, MD         
BCCA- Vancouver Center Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Kim Chi, MD    604-877-6000 ext 2734    kchi@bccancer.bc.ca   
Principal Investigator: Kim Chi, MD         
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Joel Gingerich, MD    204-787-1510    JGINGERICH@cancercare.mb.ca   
Principal Investigator: Joel Gingerich, MD         
Canada, Nova Scotia
QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Lori Wood, MD    902-473-6106    lori.wood@nshealth.ca   
Principal Investigator: Lori Wood, MD         
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Sebastien Hotte, MD    905-387-9495    hotte@hhsc.ca   
Principal Investigator: Sebastien Hotte, MD         
Durham Regional Cancer Centre (Lakeridge Health) Recruiting
Oshawa, Ontario, Canada, L1G 2B9
Contact: Gregory Lo, MD    905-576-8711    glo@lakeridgehealth.on.ca   
Principal Investigator: Gregory Lo, MD         
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Michael Ong, MD    613-737-7700 ext 70185    mong@toh.on.ca   
Principal Investigator: Michael Ong, MD         
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Srikala Sridhar, MD    416-946-2520    srikala.sridhar@uhn.ca   
Principal Investigator: Srikala Sridhar, MD         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Cristiano Ferrario, MD    514-340-8222    cristianoferrario@gmail.com   
Principal Investigator: Cristiano Ferrario, MD         
Canada, Saskatchewan
Saskatoon Cancer Center Recruiting
Saskatoon, Saskatchewan, Canada, 27N 4H4
Contact: Nayyer Iqbal, MD    306-655-2710    Nayyer.iqbal@saskcancer.ca   
Principal Investigator: Nayyer Iqbal, MD         
Sponsors and Collaborators
British Columbia Cancer Agency
Sanofi
Ozmosis Research Inc.
Investigators
Principal Investigator: Kim N Chi, MD British Columbia Cancer Agency
  More Information

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT02254785     History of Changes
Other Study ID Numbers: OZM-054
First Submitted: September 30, 2014
First Posted: October 2, 2014
Last Update Posted: March 3, 2017
Last Verified: September 2016

Keywords provided by British Columbia Cancer Agency:
poor prognosis
castrate-resistant prostate cancer
cabazitaxel
abiraterone
enzalutamide

Additional relevant MeSH terms:
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases