Study on Adding Carboplatin to Cabazitaxel for Treating Advanced Prostate Cancer
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT06470243
This clinical trial is exploring whether adding the chemotherapy drug carboplatin to the standard treatment with cabazitaxel can improve outcomes for patients with prostate cancer that has spread beyond the prostate and continues to grow despite low testosterone levels.
Patient Parameters
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Program Overview
The study aims to determine if combining carboplatin with cabazitaxel, a standard chemotherapy drug, can better treat prostate cancer that has spread and is resistant to hormone therapy. Carboplatin is known to kill or slow the growth of cancer cells, while cabazitaxel works by stopping cancer cells from dividing or spreading. Prednisone, a medication that reduces inflammation, is also given to help manage side effects and enhance the effectiveness of chemotherapy. Researchers hope that this combination will be more effective in treating advanced prostate cancer.
Description
The main goal of this study is to compare how long patients live without their cancer getting worse when treated with cabazitaxel alone versus cabazitaxel combined with carboplatin. This will be specifically looked at in patients with a certain aggressive type of prostate cancer. If the combination is effective in these patients, it will also be tested in those without this aggressive type.
Secondary goals include comparing overall survival rates, response rates based on prostate-specific antigen (PSA) levels, and other cancer markers between the two treatment groups. The study will also look at how long patients live without their cancer progressing and compare side effects between the two groups.
Participants will be randomly assigned to one of two groups:
- Group 1: Receives cabazitaxel and prednisone.
- Group 2: Receives cabazitaxel, carboplatin, and prednisone.
Both groups will receive treatment every 21 days for up to 10 cycles, as long as the cancer does not progress and side effects are manageable. Throughout the study, participants will undergo various tests, including blood tests and scans, to monitor their health and the cancer's response to treatment. After completing the study treatment, participants will have follow-up visits every 12 weeks for the first year and then every 26 weeks for up to four years or until they pass away.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of prostate cancer that has spread and is resistant to hormone therapy.
- Must have previously received treatment with docetaxel.
- Must be 18 years or older.
- Must provide a tumor sample for specific genetic testing.
- Must have cancer that is progressing, as shown by scans or rising PSA levels.
- Must not have received prior treatment with cabazitaxel or carboplatin.
- Must not be participating in another clinical trial.
- Must have adequate blood counts and organ function.
- Must agree to use effective contraception if of reproductive potential.
- Must not have other cancers that could interfere with the study.
- Must have controlled HIV if infected.
- Must agree to participate in specimen banking for future research.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group - Fayetteville | 72703 | Fayetteville | Arkansas |
| Highlands Oncology Group - Rogers | 72758 | Rogers | Arkansas |
| Highlands Oncology Group | 72762 | Springdale | Arkansas |
| Tibor Rubin VA Medical Center | 90822 | Long Beach | California |
| Beebe Medical Center | 19958 | Lewes | Delaware |
| Beebe South Coastal Health Campus | 19967 | Millville | Delaware |
| Helen F Graham Cancer Center | 19713 | Newark | Delaware |
| Medical Oncology Hematology Consultants PA | 19713 | Newark | Delaware |
| Christiana Care Health System-Christiana Hospital | 19718 | Newark | Delaware |
| Beebe Health Campus | 19971 | Rehoboth Beach | Delaware |
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