Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Drug: Cabazitaxel Drug: Carboplatin Drug: Abiraterone Drug: Prednisone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 61 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Study of Carboplatin, Cabazitaxel and Abiraterone in High Volume Metastatic Castration Sensitive Prostate Cancer |
Actual Study Start Date : | October 10, 2019 |
Estimated Primary Completion Date : | May 2025 |
Estimated Study Completion Date : | May 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Carboplatin, Cabazitaxel and Abiraterone |
Drug: Cabazitaxel
20 mg/m2 Q 21 days
Drug: Carboplatin AUC 4 Q21 Days x 6 cycles with ADT
Drug: Abiraterone 1000 mg PO daily
Drug: Prednisone 5 mg PO daily on chemotherapy completion
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patient has adequate bone marrow and organ function as defined by the following laboratory values:
Exclusion Criteria:
Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
Contact: Tamy Grainger | 612 273 2800 | tgraing1@fairview.org | |
Contact: Charles Ryan, MD | 6126249487 | ryanc@umn.edu |
United States, Arizona | |
Mayo Clinic Arizona | Recruiting |
Phoenix, Arizona, United States, 85054 | |
Principal Investigator: Alan Bryce, MD | |
United States, Illinois | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: David VanderWeele, MD, PhD | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Walter Stadler, MD | |
United States, Louisiana | |
Tulane University | Recruiting |
New Orleans, Louisiana, United States, 70112 | |
Contact: Pedro C Barata, MD.MSc | |
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Tamy Grainger 612-273-2800 tgraing1@fairview.org | |
United States, Nevada | |
Comprehensive Cancer Centers of Nevada | Recruiting |
Las Vegas, Nevada, United States, 89169 | |
Principal Investigator: Nicholas J Vogelzang, MD | |
United States, Pennsylvania | |
Thomas Jeferson University | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Principal Investigator: William Kevin Kelly, DO | |
United States, Rhode Island | |
Lifespan Cancer Institute | Recruiting |
Providence, Rhode Island, United States, 02903 | |
Principal Investigator: Andre De Souza, MD |
Principal Investigator: | Charles Ryan, MD | University of Minnesota, Division of Hematology, Oncology and Transplantation |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 26, 2019 | ||||||||
First Posted Date ICMJE | May 2, 2019 | ||||||||
Last Update Posted Date | May 28, 2021 | ||||||||
Actual Study Start Date ICMJE | October 10, 2019 | ||||||||
Estimated Primary Completion Date | May 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Prostate-Specific Antigen (PSA) or Radiographic Progression [ Time Frame: 1 Year ] Proportion of patients who have no PSA or radiographic progression as determined by RECIST 1.1 or PCWG3 criteria
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone | ||||||||
Official Title ICMJE | A Phase II Study of Carboplatin, Cabazitaxel and Abiraterone in High Volume Metastatic Castration Sensitive Prostate Cancer | ||||||||
Brief Summary | This is a phase II clinical trial in patients with metastatic castration sensitive prostate cancer. The objective of the study is to determine the efficacy and further define the safety of the treatment combination. This study will evaluate dose levels of carboplatin AUC 4 with cabazitaxel 20 mg/m2. Patients will be treated with the combination of ADT and carboplatin and cabazitaxel for 6 cycles. After 6 cycles of chemotherapy, they will start abiraterone with ADT. The primary objective is to determine the percent of subjects that have no PSA or radiographic progression at 1 year. Secondary objectives will include determining the progression-free survival, time to PSA nadir and time to PSA progression of carboplatin and cabazitaxel in combination with ADT. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Carboplatin, Cabazitaxel and Abiraterone
Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
61 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | May 2025 | ||||||||
Estimated Primary Completion Date | May 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
|
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03934840 | ||||||||
Other Study ID Numbers ICMJE | 2018LS158 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Masonic Cancer Center, University of Minnesota | ||||||||
Study Sponsor ICMJE | Masonic Cancer Center, University of Minnesota | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Masonic Cancer Center, University of Minnesota | ||||||||
Verification Date | May 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |