Combo Chemotherapy for Prostate Cancer

Not currently recruiting at 7 trial locations

Overseen By Emmanuel Antonarakis, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Masonic Cancer Center, University of Minnesota

Must be taking: ADT

Must not be taking: Chemotherapy, PARPi, Immunotherapy

Disqualifiers: Active second malignancy, Severe psychiatric illness, others

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

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of chemotherapy drugs to evaluate their effectiveness and safety in treating metastatic castration-sensitive prostate cancer. The researchers aim to determine if this treatment can halt cancer progression for a year and assess other outcomes, such as the duration patients remain cancer-free. Participants will take specific chemotherapy drugs, including Cabazitaxel and Carboplatin, for six cycles, followed by a different drug regimen. Men diagnosed with prostate cancer that has spread and who have started hormonal treatment for up to three months may be eligible to join. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot have had certain treatments like chemotherapy, PARPi, or immunotherapy for prostate cancer before. It's best to discuss your current medications with the trial team to see if they are allowed.

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

Research has shown that the combination of cabazitaxel and carboplatin is generally well-tolerated by patients. In a study using these drugs with abiraterone, most patients managed the treatment well. After one year, 77% of patients did not experience significant cancer progression, suggesting that the treatment does not cause major side effects for most people.

Cabazitaxel is already approved for treating prostate cancer, and its safety is well-known. Some patients have reported side effects like low blood counts or tiredness, but these are manageable and expected with chemotherapy. Carboplatin also has a well-established safety record and typically causes similar side effects to cabazitaxel.

Overall, current evidence indicates that the treatment seems safe. However, individual reactions vary, so discussing any concerns with the trial team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Cabazitaxel and Carboplatin for prostate cancer because it introduces a novel approach to combatting the disease. Unlike typical hormone therapies and single-agent chemotherapies, this combo leverages the unique strengths of two powerful drugs. Cabazitaxel is a next-generation chemotherapy agent that disrupts cancer cell division, while Carboplatin enhances the treatment's reach by damaging the DNA of cancer cells, making them more susceptible to destruction. This dual action could potentially improve outcomes for patients who have limited options with traditional treatments.

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

Research shows that combining cabazitaxel with carboplatin can help treat prostate cancer. Studies have found that adding carboplatin to cabazitaxel improves outcomes for men with advanced prostate cancer that no longer responds to hormone therapy. For patients who did not benefit from cabazitaxel alone, adding carboplatin led to better results. This trial will evaluate the combination of cabazitaxel, carboplatin, and abiraterone. Previous research found that this combination improved PSA (prostate-specific antigen) levels and slowed cancer growth. These findings suggest that this treatment could effectively manage prostate cancer by slowing its progression and improving patient outcomes. ^{5 6 7 8 9}

Who Is on the Research Team?

Emmanuel Antonarakis, MD

Principal Investigator

Masonic Cancer Center, University of Minnesota

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

Willing and able to provide, or have a legally authorized representative provide, written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.

I have been on hormone therapy for prostate cancer for 3 months or less.

Exclusion Criteria

PSA <2.0 ng/mL at diagnosis.

I haven't had prostate cancer treatment in the last 28 days or 5 half-lives, except for anti-androgens.

I have taken abiraterone or enzalutamide for less than 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy Treatment

Participants receive a combination of ADT, carboplatin, and cabazitaxel for 6 cycles

18 weeks

Abiraterone Treatment

Participants start abiraterone with ADT after completing chemotherapy

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Abiraterone
• Cabazitaxel
• Carboplatin
• Prednisone

Trial Overview 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.

How Is the Trial Designed?

Group I: Carboplatin, Cabazitaxel and Abiraterone Experimental Treatment 4 Interventions

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?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e17052

Real world outcomes with cabazitaxel (cab) plus ... Real world outcomes with cabazitaxel (cab) plus carboplatin (car) in metastatic castration-resistant prostate cancer (mCRPC). Authors: Shalini ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1558767323002823

Combined Cabazitaxel and Carboplatin Treatment of ... In this study we showed that patients with PSA progression during cabazitaxel monotherapy could benefit from the addition of carboplatin to cabazitaxel.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6858999/

Cabazitaxel plus carboplatin for the treatment of men with ... Carboplatin added to cabazitaxel showed improved clinical efficacy compared with cabazitaxel alone for men with metastatic castration-resistant ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.5071

A phase 2 study of cabazitaxel/carboplatin plus abiraterone ... CASCARA tested quadruplet therapy (ADT + cabazitaxel/carboplatin + abiraterone) in high-volume mCSPC, aiming to enhance PSA responses and decrease progression ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10702556/

Comparing efficacy of first-line treatment of metastatic ... Our findings underscore the efficacy of chempretarget, PARP inhibitors, and chempre in enhancing survival outcomes for mCRPC patients.

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

The efficacy and safety of cabazitaxel in the treatment of ... Cabazitaxel (CAB) has been approved for the treatment of patients with progressed metastatic castration-resistant prostate cancer (mCRPC) ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03934840

CASCARA: Castration Sensitive Carboplatin, Cabazitaxel ... This is a phase II clinical trial in patients with metastatic castration sensitive prostate cancer. The objective of the study is to determine the efficacy and ...

8. urotoday.com urotoday.com/conference-highlights/asco-2023/asco-2023-prostate-cancer/144828-asco-2023-early-results-from-cascara-a-phase-2-study-of-cabazitaxel-carboplatin-plus-abiraterone-in-high-volume-metastatic-castrate-sensitive-prostate-cancer-mcspc.html

ASCO 2023: Early Results from CASCARA Ryan and colleagues concluded that quadruplet therapy with ADT + cabazitaxel/carboplatin + abiraterone was well tolerated. At one year, 77 ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2588931125001981

Cabazitaxel Versus Abiraterone or Enzalutamide for Poor- ... Cabazitaxel Versus Abiraterone or Enzalutamide for Poor-prognosis Metastatic Castration-resistant Prostate Cancer After Docetaxel: A Phase 2 ...