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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02254785




Registration number
NCT02254785
Ethics application status
Date submitted
30/09/2014
Date registered
2/10/2014
Date last updated
6/12/2017

Titles & IDs
Public title
Cabazitaxel vs Abiraterone or Enzalutamide in Patients With Poor Prognosis Metastatic Castration-resistant Prostate Cancer
Scientific title
A Phase II, Randomized, Multi-center Study of Cabazitaxel Versus Abiraterone or Enzalutamide in Poor Prognosis-metastatic Castration-resistant Prostate Cancer
Secondary ID [1] 0 0
OZM-054
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-Resistant Prostatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cabazitaxel
Treatment: Drugs - Abiraterone
Treatment: Drugs - Enzalutamide 160mg daily (oral)

Experimental: Cabazitaxel -

Active Comparator: Abiraterone or enzalutamide -


Treatment: Drugs: cabazitaxel
Cabazitaxel 25mg/m2 intravenous every 3 weeks until disease progression

Treatment: Drugs: Abiraterone
Abiraterone 1000mg daily (oral) until disease progression

Treatment: Drugs: Enzalutamide 160mg daily (oral)
Enzalutamide 160mg daily (oral) until disease progression

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 weeks or more
Secondary outcome [1] 0 0
Duration of treatment time to progression - To measure the treatment time before any type of progression (symptomatic, PSA, or radiological) between Arm A and Arm B
Timepoint [1] 0 0
12 weeks until disease progression
Secondary outcome [2] 0 0
Progression Free Survival - To measure the progression-free survival of metastatic castration-resistant prostate cancer patients following treatment with cabazitaxel or abiraterone/enzalutamide as initial therapy.
Timepoint [2] 0 0
12 weeks until disease progression
Secondary outcome [3] 0 0
Overall Survival - To measure the overall survival of metastatic castration-resistant prostate cancer patients following treatment with cabazitaxel or abiraterone/enzalutamide as initial therapy.
Timepoint [3] 0 0
12 weeks until 2 years after last study visit

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 0 0
Monash Health-Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
Nova Scotia
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Canada
State/province [7] 0 0
Saskatchewan

Funding & Sponsors
Primary sponsor type
Other
Name
British Columbia Cancer Agency
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Ozmosis Research Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02254785
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kim N Chi, MD
Address 0 0
British Columbia Cancer Agency
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02254785