- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02218606
Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in Treatment of Metastatic Castration Resistant Prostate Cancer
October 13, 2023 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
New York, New York, United States, 10065
- Weill Cornell Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
-
-
Virginia
-
Norfolk, Virginia, United States, 23502
- Virginia Oncology Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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).
- 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.
Exclusion Criteria:
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Arm 1: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
|
|
Experimental: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily
Arm 2: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression free survival (rPFS)
Time Frame: 1 year
|
using the RECIST criteria
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PSA progression free survival (PSA PFS)
Time Frame: 1 year
|
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.
|
1 year
|
objective response rate (ORR)
Time Frame: 1 year
|
per RECIST criteria
|
1 year
|
toxicity
Time Frame: 1 year
|
The NCI CTCAE version 4.0 will be used for recording and grading AEs.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Susan Slovin, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2014
Primary Completion (Actual)
October 13, 2023
Study Completion (Actual)
October 13, 2023
Study Registration Dates
First Submitted
August 8, 2014
First Submitted That Met QC Criteria
August 15, 2014
First Posted (Estimated)
August 18, 2014
Study Record Updates
Last Update Posted (Actual)
October 16, 2023
Last Update Submitted That Met QC Criteria
October 13, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Prednisone
- Abiraterone Acetate
Other Study ID Numbers
- 14-046
- PCCTC LOI: c12-108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on Abiraterone acetate 1000 mg po daily
-
Mayo ClinicGenentech, Inc.CompletedBasal Cell CarcinomaUnited States
-
Children's Hospital Medical Center, CincinnatiNationwide Children's HospitalWithdrawnHypertension in PregnancyUnited States
-
Fundación Pública Andaluza para la gestión de la...Completed
-
Janssen Research & Development, LLCCompletedHealthy ParticipantsUnited States
-
The Affiliated Hospital of Qingdao UniversityCompletedHealthy VolunteersChina
-
Janssen Research & Development, LLCActive, not recruitingProstatic Neoplasms, Castration-ResistantBelgium, United States, United Kingdom, Canada, Israel, Spain, Italy
-
Lady Davis InstituteRecruitingAcneiform Eruptions | Cancer, Treatment-RelatedCanada
-
Cristcot LLCCristcot HCA LLCRecruitingUlcerative ProctitisSouth Africa, United States, Denmark, Philippines, Spain, Germany, India, Italy, Poland, Romania
-
Haiphong University of Medicine and PharmacyCompletedChlamydia Trachomatis Infection | Neisseria Gonorrhoeae InfectionVietnam
-
Bausch Health Americas, Inc.CompletedChronic Hepatitis C