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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Prostate-Specific Antigen (PSA) or Radiographic Progression
Secondary outcome measures
Incidence of Homologous Recombination Deficiency (HRD)
Incidence of adverse events
PSA Complete Response Rate
+3 moreTrial 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
~6670
Abiraterone
2012
Completed Phase 4
~2830
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
272 Previous Clinical Trials
14,631 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I haven't had prostate cancer treatment in the last 28 days or 5 half-lives, except for anti-androgens.I have been on hormone therapy for prostate cancer for 3 months or less.I am 18 years old or older.My blood counts and kidney, liver functions are within safe ranges for treatment.I have taken abiraterone or enzalutamide for less than 2 weeks.My cancer has spread to my organs or I have more than 3 bone lesions.My testosterone level is below 50 ng/dL, and I am on hormone therapy unless I've had orchiectomy.I haven't had major surgery or radiation therapy in the last 28 days.My prostate cancer diagnosis was confirmed through a tissue examination.I have previously been treated with chemotherapy, PARPi, or immunotherapy for prostate cancer.I do not have another cancer that could stop me from completing this trial.My nerve damage symptoms are mild.I will use a condom during and for 30 days after treatment, even if I am vasectomized.
Research Study Groups:
This trial has the following groups:- Group 1: Carboplatin, Cabazitaxel and Abiraterone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what reason is Abiraterone acetate normally consumed?
"Abiraterone is an effective medication for treating thyroiditis, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."
Answered by AI
What are the most severe possible side effects of Abiraterone?
"Abiraterone's safety is based primarily on Phase 2 data, so Power's team gave it a score of 2."
Answered by AI
How many different sites are managing this clinical trial?
"There are 11 locations for this study, which is based out of Thomas Jeferson University in Philadelphia, Pennsylvania. Some of the other notable locations include Mayo Clinic Arizona in Phoenix, Arizona and Masonic Cancer Center at University of Minnesota in Minneapolis, Minnesota."
Answered by AI
Are recruitment and enrollment still open for this experiment?
"The listed clinical trial on clinicaltrials.gov is still recruiting patients. The trial was first advertised on October 10th, 2019 and the most recent update was on April 12th, 2022."
Answered by AI
Are there other scientific case studies that have used Abiraterone?
"At this moment, there are 1098 independent studies being conducted to research Abiraterone with 329 of them being in the critical Phase 3 stage. The majority of these investigations are taking place in Shanghai. However, there are 62467 total locations running clinical trials for Abiraterone."
Answered by AI
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