Prostate CancerPhase 2NCT03934840
CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone
A Phase 2 study testing Cabazitaxel, Carboplatin and Abiraterone in people with Prostate Cancer, run by Masonic Cancer Center, University of Minnesota at 8 sites in United States.
Trial 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. 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?
- Cabazitaxel, Carboplatin and Abiraterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Oct 2019to 3 Apr 2025
- 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
- Willing and able to provide, or have a legally authorized representative provide, written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
- Histologically confirmed prostate cancer.
- High volume metastatic disease (defined as the presence of visceral metastases or ≥3 bone lesions).
- ADT for ≤3 months by day 1 of study chemotherapy; Prior episodes of ADT are allowed (i.e. ADT used previously in courses of radiation).
- Testosterone <50 ng/dL. Patients must continue primary ADT with an LHRH analogue if they have not undergone orchiectomy.
- ECOG Performance Status 0 or 1 (see Appendix A)
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- Patient has adequate bone marrow and organ function as defined by the following laboratory values:
- Absolute neutrophil count ≥ 1.5 × 10^9/L
- Platelets ≥ 100 × 10^9/L
- Hemoglobin ≥ 9 g/dl
- Serum creatinine ≤ 1.5mg/dL or estimated creatinine clearance ≥ 50 ml/min
- In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN. If the patient has liver metastases, ALT and AST <5 x ULN
- Total bilirubin < ULN; or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well-documented Gilbert's Syndrome.
- Sexually active males must use a condom during intercourse while taking study drugs and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Fertile males must use a condom with spermicide (double barrier method).
- Age ≥ 18 years
Who cannot join
- Prior exposure to any chemotherapy, PARPi, or immunotherapy for prostate cancer.
- Prior abiraterone or enzalutamide, unless therapy was for < 2 weeks
- Radiation therapy (including palliative radiotherapy to a metastatic lesion) within 14 days or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery) within 28 days of the date of the first dose.
- Other systemic therapies for prostate cancer within 28 days or 5 half-lives, whichever is shorter, prior to day 1 of chemotherapy (with the exception of anti-androgens like bicalutamide).
- PSA <2.0 ng/mL at diagnosis.
- If present, peripheral neuropathy must be ≤ Grade 1
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- Patients with an active second malignancy that could, in the investigator's opinion, potentially interfere with the patient's ability to participate and/or complete this trial.
- Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
- At least 4 weeks from prior therapy completion (including radiation and/or surgery) prior to starting the study treatment
- Clinically stable CNS tumor at the time of screening.
- Baseline screening for CNS metastases is not required unless presence of signs and/or symptoms of involvement
- Patients with severe psychiatric illness/social situations that would limit compliance with study requirements in the judgment of treating investigator.
- Patient has a history of non-compliance to medical regimen or inability to grant consent.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
Tulane University
New Orleans, Louisiana, 70112
Thomas Jeferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Lifespan Cancer Institute
Providence, Rhode Island, 02903
About this study
Official title: A Phase II Study of Carboplatin, Cabazitaxel and Abiraterone in High Volume Metastatic Castration Sensitive Prostate Cancer
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.
- Conditions
- Prostate Cancer
- Being tested
- Cabazitaxel, Carboplatin, Abiraterone, Prednisone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
20 mg/m2 Q 21 days
CarboplatinDrug
AUC 4 Q21 Days x 6 cycles with ADT
AbirateroneDrug
1000 mg PO daily
PrednisoneDrug
5 mg PO daily on chemotherapy completion
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin, Cabazitaxel and Abiraterone | Experimental | Not described Receives: Drug: Cabazitaxel; Drug: Carboplatin; Drug: Abiraterone; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate-Specific Antigen (PSA) or Radiographic Progression
Number of patients who have no PSA or radiographic progression as determined by RECIST 1.1 or PCWG3 criteria
Measured: 1 Year
Secondary outcomes (7)
Progression-Free Survival (PFS)
Percentage of participants achieving Progression Free Survival
Measured: 1 Year
PSA Nadir
Time to PSA nadir
Measured: 1 Year
Incidence of Adverse Events
Safety and Tolerability
Measured: 1 Year
PSA Complete Response Rate
PSA complete response rate (PSA <=0.2 ng/mL) in patient with mutations in DNA repair genes
Measured: 1 Year
PSA Complete Response Rate
PSA complete response rate (PSA <=0.2 ng/ml) in patient without mutations in DNA repair genes
Measured: 1 Year
PSA Progression
Time to PSA progression
Measured: 1 Year
Incidence of Homologous Recombination Deficiency (HRD)
Incidence of HRD
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 posted2 May 2019
- Study start10 Oct 2019
- Primary completion19 Jun 2023
- Study completion3 Apr 2025
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 Masonic Cancer Center, University of MinnesotaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Antonarakis, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934840
- Sponsor's protocol ID
- 2018LS158
- Other IDs
- c17-191
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2019
- Last updated
- 26 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Carboplatin, Cabazitaxel and Abiraterone in High Volume Metastatic Castration Sensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT03934840
- Acronym / sponsor ID
- 2018LS158
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Posted 26 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin, Cabazitaxel and Abiraterone | Experimental | Drug: Cabazitaxel, Drug: Carboplatin, Drug: Abiraterone, Drug: Prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Willing and able to provide, or have a legally authorized representative provide, written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
- Histologically confirmed prostate cancer.
- High volume metastatic disease (defined as the presence of visceral metastases or ≥3 bone lesions).
- ADT for ≤3 months by day 1 of study chemotherapy; Prior episodes of ADT are allowed (i.e. ADT used previously in courses of radiation).
- Testosterone <50 ng/dL. Patients must continue primary ADT with an LHRH analogue if they have not undergone orchiectomy.
Key exclusion criteria (13 listed)
- Prior exposure to any chemotherapy, PARPi, or immunotherapy for prostate cancer.
- Prior abiraterone or enzalutamide, unless therapy was for < 2 weeks
- Radiation therapy (including palliative radiotherapy to a metastatic lesion) within 14 days or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery) within 28 days of the date of the first dose.
- Other systemic therapies for prostate cancer within 28 days or 5 half-lives, whichever is shorter, prior to day 1 of chemotherapy (with the exception of anti-androgens like bicalutamide).
- PSA <2.0 ng/mL at diagnosis.
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 |
|---|---|---|
| Cabazitaxel20 mg/m2 Q 21 days | Drug | Carboplatin, Cabazitaxel and Abiraterone |
| CarboplatinAUC 4 Q21 Days x 6 cycles with ADT | Drug | Carboplatin, Cabazitaxel and Abiraterone |
| Abiraterone1000 mg PO daily | Drug | Carboplatin, Cabazitaxel and Abiraterone |
| Prednisone5 mg PO daily on chemotherapy completion | Drug | Carboplatin, Cabazitaxel and Abiraterone |
Primary outcome
Prostate-Specific Antigen (PSA) or Radiographic Progression
Time frame: 1 Year
Number of patients who have no PSA or radiographic progression as determined by RECIST 1.1 or PCWG3 criteria
7 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 1 Year
PSA Nadir
Time frame: 1 Year
Incidence of Adverse Events
Time frame: 1 Year
PSA Complete Response Rate
Time frame: 1 Year
PSA Complete Response Rate
Time frame: 1 Year
PSA Progression
Time frame: 1 Year
Incidence of Homologous Recombination Deficiency (HRD)
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 26 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Emmanuel Antonarakis, MD principal investigator
Masonic Cancer Center, University of Minnesota
8 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 Cabazitaxel, Carboplatin and Abiraterone in people with Prostate Cancer, run by Masonic Cancer Center, University of Minnesota at 8 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 15 inclusion and 13 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 26 May 2026). 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?
Prostate-Specific Antigen (PSA) or Radiographic Progression (time frame: 1 Year). 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 26 May 2026.