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Anti-tumor antibiotic

Combo Chemotherapy for Prostate Cancer

Phase 2
Waitlist Available
Led By Emmanuel Antonarakis, MD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG Performance Status 0 or 1 (see Appendix A)
Age ≥ 18 years
Must not have
Prior exposure to any chemotherapy, PARPi, or immunotherapy for prostate cancer.
If present, peripheral neuropathy must be ≤ Grade 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will test how well a combination of two drugs, carboplatin and cabazitaxel, work in treating patients with metastatic castration sensitive prostate cancer that has progressed after treatment with ADT.

Who is the study for?
Men over 18 with advanced prostate cancer that has spread, and who have started hormone therapy within the last 3 months. They must be in good physical condition (able to perform daily activities without assistance), have not had chemotherapy or certain other treatments for prostate cancer, and agree to use contraception.
What is being tested?
The trial is testing a combination of chemotherapy drugs (carboplatin and cabazitaxel) followed by abiraterone in men with metastatic prostate cancer sensitive to hormone therapy. The goal is to see if this treatment can stop the disease from progressing after one year.
What are the potential side effects?
Possible side effects include blood disorders like low white cell count which increases infection risk, fatigue, liver issues indicated by altered enzyme levels, potential nerve damage but only mild forms are allowed in participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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My blood counts and kidney, liver functions are within safe ranges for treatment.
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My cancer has spread to my organs or I have more than 3 bone lesions.
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My testosterone level is below 50 ng/dL, and I am on hormone therapy unless I've had orchiectomy.
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My prostate cancer diagnosis was confirmed through a tissue examination.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously been treated with chemotherapy, PARPi, or immunotherapy for prostate cancer.
Select...
My nerve damage symptoms are mild.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Prostate-Specific Antigen (PSA) or Radiographic Progression
Secondary study objectives
Incidence of Homologous Recombination Deficiency (HRD)
Incidence of adverse events
PSA Complete Response Rate
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Carboplatin, Cabazitaxel and AbirateroneExperimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabazitaxel
2014
Completed Phase 3
~1290
Carboplatin
2014
Completed Phase 3
~6120
Abiraterone
2012
Completed Phase 4
~4570
Prednisone
2014
Completed Phase 4
~2500

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
279 Previous Clinical Trials
15,559 Total Patients Enrolled
4 Trials studying Prostate Cancer
33 Patients Enrolled for Prostate Cancer
Emmanuel Antonarakis, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
3 Previous Clinical Trials
81 Total Patients Enrolled
2 Trials studying Prostate Cancer
69 Patients Enrolled for Prostate Cancer
Charles Ryan, MDPrincipal InvestigatorUniversity of Minnesota, Division of Hematology, Oncology and Transplantation
7 Previous Clinical Trials
118 Total Patients Enrolled
4 Trials studying Prostate Cancer
77 Patients Enrolled for Prostate Cancer

Media Library

Cabazitaxel (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03934840 — Phase 2
Prostate Cancer Research Study Groups: Carboplatin, Cabazitaxel and Abiraterone
Prostate Cancer Clinical Trial 2023: Cabazitaxel Highlights & Side Effects. Trial Name: NCT03934840 — Phase 2
Cabazitaxel (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03934840 — Phase 2
~4 spots leftby Nov 2025
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