Study on Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone for Treating Metastatic, Castration-Resistant Prostate Cancer After Docetaxel Treatment
Sponsor: ECOG-ACRIN Cancer Research Group
ClinicalTrials ID:NCT03419234
This clinical trial is exploring whether adding cabazitaxel and prednisone to abiraterone acetate and antiandrogen therapy can improve treatment outcomes for patients with metastatic prostate cancer that has become resistant to hormone therapy and has previously been treated with docetaxel.
Patient Parameters
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Program Overview
The study aims to determine if combining abiraterone acetate and antiandrogen therapy with cabazitaxel and prednisone can better control prostate cancer that has spread and is resistant to hormone therapy. Abiraterone acetate and antiandrogen therapy work by reducing or blocking hormones that fuel cancer growth. Cabazitaxel and prednisone are chemotherapy drugs that help stop cancer cells from growing and spreading. This trial will compare the effectiveness of these treatments in patients who have already received docetaxel.
Description
The main goal of this study is to see if adding cabazitaxel to abiraterone acetate can help patients with castration-resistant prostate cancer live longer without the disease getting worse. The study will also look at how this combination affects prostate-specific antigen (PSA) levels, overall survival, and the safety of the treatment.
Participants will be divided into two groups:
- Group A: Will receive abiraterone acetate and prednisone, along with cabazitaxel for up to 6 cycles. They will also continue standard hormone therapy.
- Group B: Will receive abiraterone acetate and prednisone, along with standard hormone therapy, but without cabazitaxel.
After completing the treatment, participants will have follow-up visits every 3 to 6 months for up to 5 years to monitor their health and the cancer's progression.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with prostate cancer that has spread to other parts of the body.
- Previously treated with at least 3 cycles of docetaxel for hormone-sensitive prostate cancer.
- Cancer must be progressing despite hormone therapy.
- Able to swallow tablets.
- Must continue hormone therapy throughout the study.
- Testosterone levels must be below a certain threshold.
- Must have a certain level of disease progression as defined by specific medical criteria.
- Must have good overall health with specific blood counts and organ function.
- Must agree to use effective contraception during the study and for 26 weeks after the last dose.
- Must be able to lie still for imaging if participating in an optional sub-study.
Exclusion Criteria
- Previous treatment with certain chemotherapy or hormone therapies for castration-resistant prostate cancer.
- Have a type of prostate cancer that is not suitable for abiraterone treatment.
- Currently receiving other investigational or cancer therapies, except for certain bone-strengthening treatments.
- Medical conditions that make prednisone unsafe.
- Certain liver function test results above normal limits.
- Active infections requiring antibiotics.
- Recent heart problems or severe heart conditions.
- Recent radiation therapy.
- Allergies to certain medications used in the study.
- History of other active cancers, unless treated and disease-free for 3 years.
- Life expectancy less than 12 months.
- Severe nerve damage or uncontrolled high blood pressure.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| CTCA at Western Regional Medical Center | 85338 | Goodyear | Arizona |
| Kingman Regional Medical Center | 86401 | Kingman | Arizona |
| Mercy Hospital Fort Smith | 72903 | Fort Smith | Arkansas |
| CHI Saint Vincent Cancer Center Hot Springs | 71913 | Hot Springs | Arkansas |
| Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | 72401 | Jonesboro | Arkansas |
| John L McClellan Memorial Veterans Hospital | 72205 | Little Rock | Arkansas |
| Kaiser Permanente-Deer Valley Medical Center | 94531 | Antioch | California |
| PCR Oncology | 93420 | Arroyo Grande | California |
| Sutter Auburn Faith Hospital | 95602 | Auburn | California |
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