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Metastatic Castration-Resistant Prostatic CancerPhase 2NCT02254785

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

A Phase 2 study testing cabazitaxel, Abiraterone and Enzalutamide 160mg daily (oral) in people with Metastatic Castration-Resistant Prostatic Cancer, run by British Columbia Cancer Agency at 15 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
cabazitaxel, Abiraterone and Enzalutamide 160mg daily (oral)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
15 sitesin 2 countries
Study dates
Oct 2014to May 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 22Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

Canada12 sites

  • Tom Baker Cancer Cantre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • BCCA - Kelowna

    Kelowna, British Columbia, V1Y 5J3

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Durham Regional Cancer Centre (Lakeridge Health)

    Oshawa, Ontario, L1G 2B9

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Saskatoon Cancer Center

    Saskatoon, Saskatchewan, 27N 4H4

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • BCCA- Vancouver Center

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia3 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Monash Health-Monash Medical Centre

    Clayton, Victoria, 3168

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

Other trials in Australia

About this study

Official title: A Phase II, Randomized, Multi-center Study of Cabazitaxel Versus Abiraterone or Enzalutamide in Poor Prognosis-metastatic Castration-resistant Prostate Cancer

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.

Being tested
cabazitaxel, Abiraterone, Enzalutamide 160mg daily (oral)
Keywords
poor prognosis, castrate-resistant prostate cancer, cabazitaxel, abiraterone, enzalutamide
Medical subject headings
Prostatic Neoplasms, Castration-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cabazitaxelDrug

    Also called Jevtana

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

  • AbirateroneDrug

    Also called Zytiga

    Abiraterone 1000mg daily (oral) until disease progression

  • Enzalutamide 160mg daily (oral)Drug

    Also called Xtandi

    Enzalutamide 160mg daily (oral) until disease progression

Study groups in NCT02254785
Study groupRoleWhat they receive
CabazitaxelExperimentalNot described
Receives: Drug: cabazitaxel
Abiraterone or enzalutamideActive comparatorNot described
Receives: Drug: Abiraterone; Drug: Enzalutamide 160mg daily (oral)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks or more

Secondary outcomes (3)

  1. 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

    Measured: 12 weeks until disease progression

  2. 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.

    Measured: 12 weeks until disease progression

  3. Overall Survival

    To measure the overall survival of metastatic castration-resistant prostate cancer patients following treatment with cabazitaxel or abiraterone/enzalutamide as initial therapy.

    Measured: 12 weeks until 2 years after last study visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionMay 2020 (estimated)
  4. Study completionMay 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02254785
Sponsor's protocol ID
OZM-054
Status last verified
Dec 2017
First submitted
30 Sep 2014
Last updated
6 Dec 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33836265

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cabazitaxel, Abiraterone and Enzalutamide 160mg daily (oral) in people with Metastatic Castration-Resistant Prostatic Cancer, run by British Columbia Cancer Agency at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical benefit rate (time frame: 12 weeks or more). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02254785, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.

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