Prostate CancerPhase 2NCT02218606
Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in Treatment of Metastatic Castration Resistant Prostate Cancer
A Phase 2 study testing Abiraterone acetate 1000 mg po daily, Cabazitaxel 25 mg/m2 IV and prednisone 5 mg po BID in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
The purpose of this study is to see what effects (good and bad) treatment with abiraterone acetate (an oral hormonal agent) and prednisone (a steroid) with and without cabazitaxel (a chemotherapy) have on the cancer and to find out more about whether specific laboratory tests on tumor are useful in predicting how the… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Abiraterone acetate 1000 mg po daily, Cabazitaxel 25 mg/m2 IV and prednisone 5 mg po BID
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2014to 13 Oct 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient needs to have a histologic or cytologic diagnosis of prostate cancer
- Documented progressive metastatic CRPC based on at least one of the following criteria:
- PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL.
- Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.
- Progression of bone disease (evaluable disease) or (new bone lesion(s)) by bone scan.
- Agree to undergo a biopsy of at least one metastatic site or primary prostate for determination of the RB status. Adequate archival metastatic tissue can be used if available in lieu of a biopsy if done when patient had CRPC (within 6 months of treatment start).
Show all 23Show fewer
- ECOG performance status of 0-2.
- Age ≥ 18 years.
- Have testosterone < 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH/GnRH analogue (agonist or antagonist) if they have not undergone orchiectomy.
- Patients on long term (>6 months) anti-androgen therapy (e.g. flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen. Patients that have been on an anti-androgen 6 months or less will need to discontinue anti-androgen therapy prior to treatment start (no wash out period required).
- Patients must have adequate organ and marrow function as defined below obtained within 14 days prior to treatment start:
- ANC >=1,500/μl
- Hemoglobin >=9g/dL
- Platelet count >=100,000/μl
- Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)
- Potassium > 3.5 mmol/L (within institutional normal range)
- Bilirubin ≤ ULN (unless documented Gilbert's disease)
- SGOT (AST) <=2.5 x ULN
- SGPT (ALT) <=2.5 x ULN
- The effects of cabazitaxel and abiraterone acetate on the developing human fetus at the recommended therapeutic dose are unknown. Men must agree to use adequate contraception prior to study entry, for the duration of study participation and for at least 3 months thereafter.
- Patients must be able to take oral medication without crushing, dissolving or chewing tablets.
- Patients may have received prior radiation therapy or major surgery. However, at least 21 days prior to treatment start must have elapsed since completion of radiation therapy or major surgery and patient must have recovered from all side effects at the time of randomization.
- Ability to understand and the willingness to sign a written informed consent document that is approved by the local institutional review board.
Who cannot join
- Patients may not be receiving any other investigational agents. Any prior investigational therapeutic products must be stopped at least 28 days (4 week washout) prior to treatment start.
- No prior exposure to abiraterone acetate or other specific CYP-17 inhibitors.
- No prior chemotherapy regimen. Prior isotope therapy with Strontium-89, Samarium or RAD223 should be completed at least three months (12 weeks) prior to treatment start.
- No ≥ grade 2 peripheral neuropathy
- Patients who have had antifungal agents (itraconazole, fluconazole) within 4 weeks prior to treatment start or those who have not recovered from AEs due to these agents administered more than 4 weeks earlier.
- Patients with a history of pituitary or adrenal dysfunction, active or symptomatic viral hepatitis or chronic liver disease are not eligible.
Show all 11Show fewer
- Patients with known symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other AEs.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabazitaxel or other drugs formulated with polysorbate 80; or abiraterone acetate.
- Patients may continue on a daily Multi-Vitamin, calcium and Vitamin D, but all other herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be discontinued before treatment start. Patients must not be planning to receive any concurrent cytotoxic chemotherapy, surgery for their prostate cancer, or radiation therapy during protocol treatment.
- Patients on stable doses of bisphosphonates or the RANK-L inhibitor, Denosumab, which have been started no less than 4 weeks prior to treatment start, may continue on this medication, however patients are not allowed to initiate bisphosphonate/Denosumab therapy during the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medical Center
New York, New York, 10065
Virginia Oncology Associates
Norfolk, Virginia, 23502
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: An Exploratory Randomized Phase II Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in Treatment of Metastatic Castration Resistant Prostate Cancer
The purpose of this study is to see what effects (good and bad) treatment with abiraterone acetate (an oral hormonal agent) and prednisone (a steroid) with and without cabazitaxel (a chemotherapy) have on the cancer and to find out more about whether specific laboratory tests on tumor are useful in predicting how the patient will respond to treatment.
- Conditions
- Prostate Cancer
- Being tested
- Abiraterone acetate 1000 mg po daily, Cabazitaxel 25 mg/m2 IV, prednisone 5 mg po BID
- Keywords
- Abiraterone Acetate, CABAZITAXEL, CASTRATION RESISTANT, 14-046, Prostate Cancer Clinical Trials Consortium
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone acetate 1000 mg po dailyDrug
Cabazitaxel 25 mg/m2 IVDrug
prednisone 5 mg po BIDDrug
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID | Experimental | Arm 1: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID Receives: Drug: Abiraterone acetate 1000 mg po daily; Drug: prednisone 5 mg po BID |
| Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily | Experimental | Arm 2: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID Receives: Drug: Abiraterone acetate 1000 mg po daily; Drug: Cabazitaxel 25 mg/m2 IV; Drug: prednisone 5 mg po BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (rPFS)
using the RECIST criteria
Measured: Up to 100 weeks
Secondary outcomes (3)
PSA Progression Free Survival (PSA PFS)
For each patient, use a waterfall plot to report the percent change in PSA from baseline to 12 weeks (or earlier for those who discontinue therapy) and the maximum decline in PSA that occurs at any point after treatment.
Measured: Up to 100 weeks
Objective Response Rate (ORR)
per RECIST criteria
Measured: 1 year
Participants With Maximum Overall Grade ≥3 AEs
The NCI CTCAE version 4.0 will be used for recording and grading AEs.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Slovin, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218606
- Sponsor's protocol ID
- 14-046
- Other IDs
- PCCTC LOI: c12-108
- Status last verified
- Oct 2023
- First submitted
- 8 Aug 2014
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Randomized Phase II Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in Treatment of Metastatic Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02218606
- Acronym / sponsor ID
- 14-046
- Conditions
- Prostate Cancer
- Keywords
- Abiraterone Acetate, CABAZITAXEL, CASTRATION RESISTANT, 14-046, Prostate Cancer Clinical Trials Consortium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Sanofi, Thomas Jefferson University, Weill Medical College of Cornell University
- Study start
- Aug 2014 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 18 Aug 2014 (estimated)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see what effects (good and bad) treatment with abiraterone acetate (an oral hormonal agent) and prednisone (a steroid) with and without cabazitaxel (a chemotherapy) have on the cancer and to find out more about whether specific laboratory tests on tumor are useful in predicting how the patient will respond to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID | Experimental | Drug: Abiraterone acetate 1000 mg po daily, Drug: prednisone 5 mg po BIDArm 1: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID |
| Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily | Experimental | Drug: Abiraterone acetate 1000 mg po daily, Drug: Cabazitaxel 25 mg/m2 IV, Drug: prednisone 5 mg po BIDArm 2: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patient needs to have a histologic or cytologic diagnosis of prostate cancer
- PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL.
- Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.
- Progression of bone disease (evaluable disease) or (new bone lesion(s)) by bone scan.
Key exclusion criteria (11 listed)
- Patients may not be receiving any other investigational agents. Any prior investigational therapeutic products must be stopped at least 28 days (4 week washout) prior to treatment start.
- No prior exposure to abiraterone acetate or other specific CYP-17 inhibitors.
- No prior chemotherapy regimen. Prior isotope therapy with Strontium-89, Samarium or RAD223 should be completed at least three months (12 weeks) prior to treatment start.
- No ≥ grade 2 peripheral neuropathy
- Patients who have had antifungal agents (itraconazole, fluconazole) within 4 weeks prior to treatment start or those who have not recovered from AEs due to these agents administered more than 4 weeks earlier.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abiraterone acetate 1000 mg po daily | Drug | Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID, Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily |
| Cabazitaxel 25 mg/m2 IV | Drug | Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily |
| prednisone 5 mg po BID | Drug | Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID, Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily |
Primary outcome
Progression Free Survival (rPFS)
Time frame: Up to 100 weeks
using the RECIST criteria
3 secondary outcomes
PSA Progression Free Survival (PSA PFS)
Time frame: Up to 100 weeks
Objective Response Rate (ORR)
Time frame: 1 year
Participants With Maximum Overall Grade ≥3 AEs
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Slovin, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abiraterone acetate 1000 mg po daily, Cabazitaxel 25 mg/m2 IV and prednisone 5 mg po BID in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
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 23 inclusion and 11 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 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (rPFS) (time frame: Up to 100 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2024.