Carboplatin + Cabazitaxel for Prostate Cancer

Recruiting at 174 trial locations

Overseen By Paul Corn

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: SWOG Cancer Research Network

Disqualifiers: Prior cabazitaxel, carboplatin, brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 23

Duration: 30 weeks

528 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding carboplatin to the usual chemotherapy drug cabazitaxel improves treatment for prostate cancer that resists low testosterone levels and has spread to other parts of the body. Carboplatin, a platinum-based drug, stops or slows tumor growth, while cabazitaxel prevents cancer cells from dividing and spreading. This trial suits those with prostate cancer that continues to grow despite low testosterone and has spread to other body parts, especially if they haven't tried carboplatin or cabazitaxel before. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial requires that you stop certain treatments like chemotherapies, bone targeting therapies, immunotherapies, and clinical trial agents at least 21 days before joining. However, it doesn't specify about other medications, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cabazitaxel is generally safe, though it can cause side effects. Almost all patients in studies experience some side effects. Serious side effects occur in about 39% of cases, and more than half may have severe reactions. However, medical care can usually manage these side effects.

When combined with carboplatin, studies suggest this mix is also generally well-tolerated. Side effects are more common with the combination than with cabazitaxel alone, but it remains considered safe. This combination has improved treatment effectiveness in some patients with advanced prostate cancer.

Overall, both treatments have been tested in people and are known to be tolerable, though side effects are possible. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about combining cabazitaxel with carboplatin for prostate cancer because this duo offers a fresh approach compared to standard treatments like androgen deprivation therapy and docetaxel. Cabazitaxel already targets cancer cells by disrupting their ability to divide, but when paired with carboplatin, which causes DNA damage in cancer cells, it might enhance the overall effectiveness. This combination aims to tackle cancer cells more aggressively, potentially slowing disease progression in patients who may not respond well to existing options.

What evidence suggests that this trial's treatments could be effective for metastatic castrate-resistant prostate cancer?

Studies have shown that cabazitaxel effectively treats prostate cancer that has spread and does not respond to low testosterone levels. It helps men live longer and often reduces tumor size. In this trial, one group of participants will receive cabazitaxel with prednisone, while another group will receive a combination of cabazitaxel, carboplatin, and prednisone. Research indicates that adding carboplatin to cabazitaxel can significantly lower prostate-specific antigen (PSA) levels, a marker for prostate cancer, in some patients. This suggests the combination might control cancer growth more effectively than cabazitaxel alone. ^{1 4 6 7 8}

Who Is on the Research Team?

Paul Corn

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for adults with castrate-resistant prostate cancer that has spread, who have previously been treated with docetaxel. They must have a confirmed diagnosis and available tumor biopsy material. Participants need to consent to the study and can provide tissue samples collected within the last year.

Inclusion Criteria

I have a confirmed diagnosis of prostate cancer.

My prostate cancer is resistant to hormone therapy and has spread, shown by scans.

I have signed the informed consent for this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive cabazitaxel with or without carboplatin and prednisone for up to 10 cycles, each cycle lasting 21 days

30 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

5 years

Every 12 weeks for 1 year, then every 26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cabazitaxel
• Carboplatin

Trial Overview The trial is testing if adding Carboplatin to standard Cabazitaxel chemotherapy improves outcomes in metastatic castrate-resistant prostate cancer. Prednisone will also be used to reduce side effects and help chemotherapy work better.

How Is the Trial Designed?

Group I: Arm 2 (cabazitaxel, carboplatin, prednisone) Experimental Treatment 9 Interventions

Patients receive cabazitaxel and carboplatin IV over 60 minutes on day 1 of each cycle and prednisone PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone scan, CT, PET, or MRI throughout the trial and chest x-ray before randomization.

Group II: Arm 1 (cabazitaxel, prednisone) Active Control 8 Interventions

Patients receive cabazitaxel IV over 60 minutes on day 1 of each cycle and prednisone PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, bone scan, CT, PET, or MRI throughout the trial and chest x-ray before randomization.

Cabazitaxel is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Jevtana for:

• Hormone refractory metastatic prostate cancer

Approved in United States as Jevtana for:

• Metastatic castration-resistant prostate cancer

Approved in Canada as Jevtana for:

• Hormone-refractory metastatic prostate cancer

Approved in Japan as Jevtana for:

• Prostate cancer

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Cabazitaxel (Jevtana®) is an effective treatment for hormone-refractory metastatic prostate cancer, showing a 2.4-month increase in median overall survival and a 30% reduction in the risk of death compared to mitoxantrone, based on the main study for its EU approval.

The recommended dosage is 25 mg/m2 administered every 3 weeks via intravenous infusion, alongside daily oral prednisone, with common side effects including anemia and neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European Medicines Agency review of cabazitaxel (Jevtana®) for the treatment of hormone-refractory metastatic prostate cancer: summary of the scientific assessment of the committee for medicinal products for human use. Pean, E., Demolis, P., Moreau, A., et al.[2021]

Cabazitaxel is an effective second-line treatment for men with metastatic castration-resistant prostate cancer (mCRPC), showing a median survival of 15.1 months compared to 12.7 months with mitoxantrone in a randomized trial.

While cabazitaxel has demonstrated efficacy, it is associated with significant adverse effects, including myelosuppression and febrile neutropenia, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabazitaxel (jevtana): a novel agent for metastatic castration-resistant prostate cancer. Nightingale, G., Ryu, J.[2023]

Cabazitaxel, when combined with prednisone, significantly improves overall survival in patients with hormone-refractory metastatic prostate cancer who have previously been treated with docetaxel, as shown in the pivotal TROPIC trial.

The treatment also enhances progression-free survival and response rates for tumor and PSA levels, while maintaining an acceptable safety profile, with common side effects including hematological issues and diarrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabazitaxel: a guide to its use in hormone-refractory metastatic prostate cancer. Keating, GM.[2021]

Adding carboplatin to cabazitaxel significantly improved progression-free survival in men with metastatic castration-resistant prostate cancer, increasing the median survival from 4.5 months to 7.3 months in a phase 2 trial with 160 participants.

While the combination treatment had more adverse events compared to cabazitaxel alone, it was still considered safe and well tolerated, with no treatment-related deaths reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabazitaxel plus carboplatin for the treatment of men with metastatic castration-resistant prostate cancers: a randomised, open-label, phase 1-2 trial. Corn, PG., Heath, EI., Zurita, A., et al.[2021]

Cabazitaxel is a potentially effective treatment for castration-resistant prostate cancer (CRPC) in patients aged 80 years and older, showing similar efficacy in overall survival and PSA response rates compared to younger patients.

The safety profile of cabazitaxel is comparable across age groups, with high rates of adverse drug reactions (ADRs) in both patients aged <80 (77.2%) and ≥80 years (79.6%), primarily involving hematologic toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabazitaxel in patients aged ≥80 years with castration-resistant prostate cancer: Results of a post-marketing surveillance study in Japan. Matsubara, N., Suzuki, K., Kazama, H., et al.[2021]

Cabazitaxel, marketed as Jevtana, is an FDA-approved treatment for hormone-refractory prostate cancer that is resistant to docetaxel, showing efficacy in patients who have failed previous treatments.

As a microtubule depolymerization inhibitor, cabazitaxel can penetrate the blood-brain barrier and is administered in combination with prednisone, providing a new option for patients with limited treatment alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabazitaxel: a novel drug for hormone-refractory prostate cancer. Malhotra, M., Dhingra, R., Sharma, T., et al.[2019]

Cabazitaxel, a new chemotherapy drug, has been shown to improve overall survival by 2.4 months in patients with metastatic castration-resistant prostate cancer who have progressed after docetaxel treatment, compared to the older drug mitoxantrone.

While cabazitaxel is effective, it carries a risk of significant hematologic toxicity, including febrile neutropenia, necessitating the use of hematopoietic growth factors in cases of severe neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cabazitaxel after docetaxel: a new option in metastatic castration-resistant prostate cancer]. Lheureux, S., Joly, F.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11459482/

The Efficacy of Cabazitaxel in Treating Prostate Cancer Cabazitaxel, a second-generation taxane chemotherapy agent, has demonstrated efficacy in treating metastatic castration-resistant prostate cancer (mCRPC)

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.162

Survival outcomes based on line of therapy and treatment ... We aimed to assess the survival outcomes and treatment patterns in pts with mCRPC receiving single-agent cabazitaxel in a real-world setting.

3. jevtana.com jevtana.com/study-results

See JEVTANA® (cabazitaxel) Injection Clinical Study Results JEVTANA helped men live longer and also shrank tumors after docetaxel. JEVTANA was shown to be effective in 3 clinical studies with men who: Had prostate cancer ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/iju.70019

Current Evidence on Cabazitaxel for Prostate Cancer ... A deeper understanding of PC biology, along with a comprehensive collection of real-world data, will be crucial to refining treatment strategies ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12310731/

The efficacy and safety of cabazitaxel in the treatment of ... The results showed that CAB 25 mg/m2 significantly improved OS compared to androgen receptor pathway inhibitor (ARPI) (1.50 [1.30, 1.70]) and ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(20)33517-1/fulltext

Safety Data of Cabazitaxel (JEVTANA®) in Patients ... The TROPIC1 study demonstrated that cabazitaxel (a novel tubulin-binding taxane drug) improves overall survival of patients (pts) with metastatic castration ...

7. pro.campus.sanofi pro.campus.sanofi/us/products/jevtana/efficacy-card-trial

JEVTANA ® (cabazitaxel) injection: CARD Trial - Efficacy & ... ARs (Safety Population), No. (%) ; Any AR, 124 (98.4), 117 (94.4) ; Grade ≥3 AR, 71 (56.3), 65 (52.4) ; Serious AR, 49 (38.9), 48 (38.7) ; AR leading to permanent

8. nature.com nature.com/articles/s41416-019-0611-6

Overall and progression-free survival with cabazitaxel in ... At cabazitaxel initiation, median age was 70 years median time elapsed since prostate cancer diagnosis was 5.5 years, 20% had visceral ...