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

NCT02254785 | Unknown Phase 2

• 1 other identifier: OZM-054
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 15

Brief Summary

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.

Conditions

Metastatic Castration-Resistant Prostatic Cancer

Keywords

poor prognosis; castrate-resistant prostate cancer; cabazitaxel; abiraterone; enzalutamide

Outcome Measures

Primary Outcomes (1)

• Clinical benefit rate

  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.

  12 weeks or more

Secondary Outcomes (3)

• Duration of treatment time to progression

  12 weeks until disease progression

• Progression Free Survival

  12 weeks until disease progression

• Overall Survival

  12 weeks until 2 years after last study visit

Study Arms (2)

Cabazitaxel

EXPERIMENTAL

Drug: cabazitaxel

Abiraterone or enzalutamide

ACTIVE COMPARATOR

Drug: Abiraterone; Drug: Enzalutamide 160mg daily (oral)

Interventions

cabazitaxel DRUG

Cabazitaxel 25mg/m2 intravenous every 3 weeks until disease progression

Also known as: Jevtana

Cabazitaxel

Abiraterone DRUG

Abiraterone 1000mg daily (oral) until disease progression

Also known as: Zytiga

Abiraterone or enzalutamide

Enzalutamide 160mg daily (oral) DRUG

Enzalutamide 160mg daily (oral) until disease progression

Also known as: Xtandi

Abiraterone or enzalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Sanofi: collaborator
• Ozmosis Research Inc.: collaborator

Study Sites (15)

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Monash Health-Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Tom Baker Cancer Cantre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Kelowna

Kelowna, British Columbia, V1Y 5J3, Canada

Location

BCCA- Vancouver Center

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Durham Regional Cancer Centre (Lakeridge Health)

Oshawa, Ontario, L1G 2B9, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Saskatoon Cancer Center

Saskatoon, Saskatchewan, 27N 4H4, Canada

Location

Related Publications (1)

• Annala M, Fu S, Bacon JVW, Sipola J, Iqbal N, Ferrario C, Ong M, Wadhwa D, Hotte SJ, Lo G, Tran B, Wood LA, Gingerich JR, North SA, Pezaro CJ, Ruether JD, Sridhar SS, Kallio HML, Khalaf DJ, Wong A, Beja K, Schonlau E, Taavitsainen S, Nykter M, Vandekerkhove G, Azad AA, Wyatt AW, Chi KN. Cabazitaxel versus abiraterone or enzalutamide in poor prognosis metastatic castration-resistant prostate cancer: a multicentre, randomised, open-label, phase II trial. Ann Oncol. 2021 Jul;32(7):896-905. doi: 10.1016/j.annonc.2021.03.205. Epub 2021 Apr 6.

  PMID: 33836265 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

cabazitaxel; abiraterone; Abiraterone Acetate; enzalutamide

Condition Hierarchy (Ancestors)

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Kim N Chi, MD

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 2, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

AU (3); CA (12)