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Bone Metastatic Prostate CancerPhase 2CABA-BONENCT02512458

Study of the Effect of Chemotherapy With Cabazitaxel on Prostate Cancer

A Phase 2 study testing Cabazitaxel in people with Bone Metastatic Prostate Cancer, run by Hellenic Cooperative Oncology Group at 6 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, open-label, single arm translational study of cabazitaxel in bone Castration Resistant metastatic Pancreatic Cancer (mCRPC) patients. Patient will be treated with intravenous (iv) cabazitaxel 25mg/m2 every (q) 21days per standard clinical practice for up to 10 cycles or until disease progression… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Bone Metastatic Prostate Cancer
What is being tested?
Cabazitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
6 sitesGreece
Study dates
29 Oct 2015to 27 Dec 2019
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

  • Male patients older than 18 years
  • Histologically proven adenocarcinoma of the prostate
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Serum testosterone levels < 50ng/ml (1.7 nmol/L)
  • Ongoing gonadal androgen deprivation therapy with Luteinizing Hormone-Releasing Hormone (LHRH) analogues or orchiectomy. Patients, who have not had an orchiectomy, must be maintained on effective LHRH analogue therapy for the duration of the trial
  • Progression of disease despite androgen ablation - Either documented osseous or soft tissue metastatic disease progression or by PSA criteria progression
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  • Presence of bone metastases
  • Off diethylstilbestrol (DES) or steroids treatment for ≥ 4 weeks and for antiandrogens > 4 weeks.
  • No prior treatment with cabazitaxel
  • Able to comply with study requirements
  • Written information delivered to the patient. Patient must be willing and able to comply with protocol requirements. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must also have signed an authorization for the release of their protected health information.

Who cannot join

  • Histologic variants in the primary tumor (histologic variants other than adenocarcinoma)
  • Concurrent therapy with other therapeutic or hormonal agent, including androgen receptor antagonists (bicalutamide, flutamide, nilutamide, enzalutamide), any dose of megestrol acetate (Megace), ketoconazole, abiraterone acetate, finasteride (Proscar), dutasteride (Avodart) any herbal product known to decrease PSA levels (e.g., Saw Palmetto and PC-SPES),
  • Active infection or intercurrent illnesses that are not controlled
  • Prior radiation therapy completed < 4 weeks prior to enrolment
  • Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery
  • Structurally unstable bone lesions suggesting impending fracture
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  • Any "currently active" second malignancy, other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy, if they have completed therapy and are considered by their physician to be at least less than 30% risk of relapse over next 3 months
  • Active psychiatric illnesses/social situations that would limit compliance with protocol requirements.
  • Active or uncontrolled autoimmune disease that may require corticosteroid therapy during study.
  • Severely compromised immunological state, including being positive for the human immunodeficiency virus (HIV)
  • Known acute or chronic hepatitis B or C
  • Other investigational therapies (targeted or vaccine) will require a 4 week washout period before treatment initiation
  • Ιnitiation of bisphosphonate or denosumab therapy within 4 weeks prior to first dose of study drug. Patients on stable doses of bisphosphonates or denosumab that show subsequent tumor progression may continue on this medication; however, patients are discouraged to initiate bisphosphonate therapy during the study.
  • Patients receiving an investigational drug within 4 weeks prior to enrolment
  • History of severe hypersensitivity reaction (grade ≥3) to polysorbate 80 containing drugs
  • Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments)
  • Inadequate organ or bone marrow function

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Greece6 sites

  • Athens Medical Center, Dept of Medical Oncology

    Athens, Maroussi, 15125

  • General Hospital of Athens "Alexandra", Unit of Medical Oncology, Dept of Clinical Therapeutics

    Athens, 11528

  • Agii Anargiri Cancer Hospital, 3rd Dept of Medical Oncology

    Athens, 14564

  • Ioannina University Hospital, Dept of Medical Oncology

    Ioannina, 45110

  • EUROMEDICA General Clinic of Thessaloniki

    Thessaloniki, Thessaloniki, 54645

  • Papageorgiou General Hospital, Dept of Medical Oncology

    Thessaloniki, 56429

Other trials in Greece

About this study

Official title: A Study of Cabazitaxel Treatment in Castration Resistant Bone Metastatic Prostate Cancer Patients Evaluating the Tumor Microenvironment

This is a prospective, open-label, single arm translational study of cabazitaxel in bone Castration Resistant metastatic Pancreatic Cancer (mCRPC) patients. Patient will be treated with intravenous (iv) cabazitaxel 25mg/m2 every (q) 21days per standard clinical practice for up to 10 cycles or until disease progression or unacceptable toxicity or physician's decision or patient's consent withdrawal (whichever occurs first).

Read the detailed description

This is an open-label, interventional study to explore the effect of Cabazitaxel on survival pathways and androgen signaling in the tumor microenvironment (bone marrow) of patients with castration resistant metastatic prostate cancer.

A total of 30 evaluable patients are needed. An estimated 50% chance of failure to harvest evaluable bone marrow biopsy or aspirate is anticipated based on investigators prior experience. Thus a total of 60 patients will be accrued in the study. This will provide the investigators an 80% power to detect an effect size of at least 0.82, using a two-sided paired t-test and at a 0.05 significance level.The changes in androgen signaling (androgen receptor expression and other survival pathway markers, between baseline and 9 weeks will be assessed by paired t-test and Wilcoxon signed-rank test. The association between serum Prostate-Specific Androgen (PSA) and bone marrow androgen signaling level will be evaluated using scatter plot and spearman's correlation coefficient. Similar methods will be used to explore the association between circulating androgens and those in the bone marrow.

Biomarker data will also be summarized and compared between baseline and after treatment using paired t-test or Wilcoxon signed-rank test.

ECOG changes from baseline will be provided for each treatment period. All Adverse Events (AE) will be graded using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) classification, version 4.3.

Summary tables of Adverse Events (AE)s, Treatment Emergent Adverse Event(TEAE), Serious Adverse Events (SAE)s and withdrawals for adverse events will be provided by treatment period. Adverse events will be summarized by worst severity grade AEs.

All registered subjects who take at least 1 dose of agent will be included in the safety analyses. Adverse events will be summarized by worst severity grade. AEs, as well as treatment-emergent AEs, will be summarized by system organ class, and preferred term. Investigational Medicinal Products (IMP) -related adverse events, adverse events leading to death or to discontinuation from treatment, events classified as NCI-CTCAE v4 Grade 3 or Grade 4 (or moderate/severe if other rating scale is used), (IMP)-related events, and serious adverse events will be summarized separately.

Being tested
Cabazitaxel

What participants receive

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

  • CabazitaxelDrug

    Also called Jevtana

Study groups in NCT02512458
Study groupRoleWhat they receive
CabazitaxelExperimentalPatient will be treated with iv cabazitaxel 25mg/m2 q 21days per standard clinical practice for up to 10 cycles or until disease progression or unacceptable toxicity or physician's decision or patient's consent withdrawal (whichever occurs first).
Receives: Drug: Cabazitaxel

What is being measured

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

  1. Molecular effects of treatment with Cabazitaxel on the tumor microenvironment

    To explore molecular effects of treatment with Cabazitaxel on the tumor microenvironment of patients with mCRPC in correlation with measures of outcome (ie clinical benefit, Prostate-Specific Androgen (PSA) decline, radiographic response, time to treatment discontinuation), in an effort to identify predictors of response or resistance to therapy.

    Measured: On week 9 and on week 36

Secondary outcomes (10)

  1. Eastern Cooperative Oncology Group (ECOG) performance status

    Measured: Up to 30 weeks

  2. PSA response

    Measured: Up to 30 weeks

  3. Radiological progression-free survival according to Prostate Cancer Working Group 2 (PCWG2)

    Measured: Up to 30 weeks or until Disease Progression

  4. Pain status using a numerical rating scale from 0 to 10.

    Measured: Up to 30 weeks

  5. Time to best clinical benefit (based on pain, analgesic consumption, and performance status)

    Measured: Up to 30 weeks

  6. Overall survival

    Measured: Up to 40 months

  7. Explore the potential association between serum PSA with bone marrow (BM) androgen (testosterone, dehydrotestosterone, androstenedione, cortisol, pregnenolone and progesterone) levels and androgen receptor expression while on Cabazitaxel

    Measured: Up to 30 weeks

  8. Prospective collection of BM biopsies and aspirates to measure the effect of Cabazitaxel on markers of bone metabolism(N-terminal Androgen Receptor(AR),C-terminal AR,splice variant presence,NKX3.1,AR coactivator expression,CYP17,p53,Aurora kinase,UBE2C)

    Measured: Up to 30 weeks

  9. Correlation between levels of circulating androgens(testosterone, dehydrotestosterone,androstenedione,cortisol,pregnenolone and progesterone)and those in the bone marrow before and during treatment with Cabazitaxel with measures of efficacy

    Measured: Up to 30 weeks

  10. Number of participants with Serious and Non-Serious Adverse Events graded according to National Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0

    Measured: Up to 30 weeks

Timeline

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

  1. First posted31 Jul 2015 (estimated)
  2. Study start29 Oct 2015
  3. Primary completionDec 2019
  4. Study completion27 Dec 2019

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02512458
Sponsor's protocol ID
HE 9A/14
Other IDs
2014-004485-21, 2014
Acronym
CABA-BONE
Status last verified
Feb 2020
First submitted
21 Jul 2015
Last updated
10 Feb 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabazitaxel in people with Bone Metastatic Prostate Cancer, run by Hellenic Cooperative Oncology Group at 6 sites in Greece.

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 11 inclusion and 18 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: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Greece. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Molecular effects of treatment with Cabazitaxel on the tumor microenvironment (time frame: On week 9 and on week 36). 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 NCT02512458.

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 10 Feb 2020.

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