What is the mechanism of action of this treatment?

Cabazitaxel, a chemotherapy drug, inhibits cell division by stabilizing microtubules, leading to cancer cell death, while prednisone, a corticosteroid, reduces inflammation and enhances chemotherapy effectiveness. These mechanisms are crucial for prostate cancer patients as they directly target cancer cells and improve treatment outcomes. Other common treatments include androgen deprivation therapy (ADT), which reduces androgen levels to slow cancer growth, and docetaxel, another taxane that disrupts microtubule function. Understanding these mechanisms helps in selecting the most effective treatment regimen and managing side effects.

What side effects are associated with this type of intervention?

Common treatments for advanced prostate cancer, such as cabazitaxel plus prednisone, are associated with several side effects. Cabazitaxel can cause significant toxicity, including grade 3 or greater neutropenia (82%), febrile neutropenia (8%), and diarrhea (47%, with 6% being grade ≥3). Docetaxel, another chemotherapeutic agent, can lead to severe neutropenia (53% with a three-week schedule), febrile neutropenia (14% with a three-week schedule), and other side effects like fatigue and infection. Prednisone, used to reduce inflammation and enhance chemotherapy, can cause fluid retention, hypokalemia, and hypertension. These side effects highlight the need for careful management and monitoring during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that are similar to the combination of cabazitaxel and prednisone. Cabazitaxel itself is approved for use in metastatic castration-resistant prostate cancer (mCRPC) following prior treatment with docetaxel. Other chemotherapy agents like docetaxel, often combined with prednisone, have also been approved for mCRPC. Additionally, androgen receptor inhibitors such as enzalutamide and abiraterone (often combined with prednisone) have been approved for both castration-sensitive and castration-resistant prostate cancer. These treatments work by inhibiting cancer cell growth and reducing inflammation, thereby enhancing the effectiveness of chemotherapy.

What other types of research exist?

Promising alternatives to Cabazitaxel plus prednisone for prostate cancer treatment in 2024 include: 1) Darolutamide plus docetaxel and androgen deprivation therapy (ADT), which has shown significant survival benefits in the ARASENS trial. 2) Lutetium Lu 177 vipivotide tetraxetan, which demonstrated higher PSA decline rates and fewer severe adverse events compared to Cabazitaxel in the ANZUP 1603 trial. 3) ADT combined with second-generation antiandrogens like enzalutamide or apalutamide, which have shown significant activity in castration-resistant prostate cancer.

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Taxane

Docetaxel vs Cabazitaxel for Prostate Cancer (CABPOSTAAT Trial)

Phase 2

Waitlist Available

Led By fred Saad, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Appearance of 2 or more new bone lesions. They must be confirmed by other imaging modalities (CT; MRI) if ambiguous results (PCWG2), and/or

Progressive disease (PD) while receiving AR targeted therapy with abiraterone acetate or enzalutamide by at least one of the following:

Must not have

- Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v4.0) at the time of randomization.

- Prior isotope therapy, whole bony pelvic radiotherapy, or radiotherapy to >30% of bone marrow.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up hrough study completion, an average of 1 year

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 30 Other Conditions

Summary

This trial tests if cabazitaxel plus prednisone can help patients with advanced prostate cancer that hasn't responded to other treatments. Cabazitaxel stops cancer cells from growing, and prednisone helps manage side effects. Cabazitaxel was approved by the US FDA after a previous study showed improved survival in patients who had previously been treated with another medication.

Who is the study for?

Men with advanced prostate cancer that has spread and worsened despite hormone therapy with abiraterone or enzalutamide. They must have a rising PSA level, measurable disease progression, effective castration (low testosterone), and be able to consent. Excluded are those who've had certain prior treatments, uncontrolled other cancers or medical conditions, severe side effects from past cancer therapies, or inadequate organ function.

What is being tested?

The trial is testing whether Cabazitaxel plus prednisone can improve survival for men with metastatic castration-resistant prostate cancer compared to Docetaxel plus prednisone after previous treatment failure. It's a Phase II study focusing on progression-free and overall survival outcomes.

What are the potential side effects?

Potential side effects include allergic reactions to the drugs used; blood disorders like low red cells, white cells or platelets; liver issues indicated by altered enzyme levels; heart problems in those with history of heart disease; gastrointestinal complications such as ulcers; and possible hormonal imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least 2 new bone lesions confirmed by CT or MRI.

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My cancer has worsened despite treatment with abiraterone or enzalutamide.

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My cancer has grown or spread, and it can be measured by scans.

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My prostate cancer was confirmed by a lab test.

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My cancer has spread to other parts of my body.

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My testosterone levels are very low, meeting the castration criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no major side effects from cancer treatment, except for hair loss.

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I have not had extensive radiation therapy affecting my bone marrow.

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I am younger than 18 or below the legal age of majority in my country.

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I do not have a history of brain metastases or current brain/spinal cord issues.

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My daily activity is somewhat limited by my health.

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In the last 3 months, I haven't had severe stomach issues, bowel diseases, lung clots, or uncontrolled blood clots.

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I have AIDS or HIV that needs treatment.

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I have a known history of abnormal aldosterone levels.

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I cannot swallow pills whole.

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My liver disease is moderately to severely impaired.

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I cannot take corticosteroid medications due to health reasons.

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I do not have severe nerve pain or tingling in my hands and feet.

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I have had serious heart issues or a heart attack in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hrough study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hrough study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and hrough study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PSA response rate at 6 and 12 months

Secondary study objectives

Duration of tumor response

Overall Survival

Pain response: BPI-SF pain intensity item scores

+4 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 30 Other Conditions

This treatment demonstrated efficacy for 30 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cabazitaxel plus prednisoneExperimental Treatment1 Intervention

Cabazitaxel: Single-dose vial, containing a total of 60 mg of cabazitaxel expressed as anhydrous and solvent-free basis, per 1.5 mL of solution. Cabazitaxel will be administered by IV route Prednisone will be administered orally, 5 mg twice daily (10 mg per day total dose). Prednisone will be administered by oral route

Group II: Docetaxel plus prednisoneActive Control1 Intervention

Docetaxel is formulated in polysorbate 80 and commercially available as 80 mg/2.0 mL single-dose vials with accompanying diluent (13% ethanol in water for injection) for IV use. Prednisone will be administered orally, 5 mg twice daily (10 mg per day total dose). Prednisone will be administered by oral route

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cabazitaxel, a chemotherapy drug, inhibits cell division by stabilizing microtubules, leading to cancer cell death, while prednisone, a corticosteroid, reduces inflammation and enhances chemotherapy effectiveness. These mechanisms are crucial for prostate cancer patients as they directly target cancer cells and improve treatment outcomes. Other common treatments include androgen deprivation therapy (ADT), which reduces androgen levels to slow cancer growth, and docetaxel, another taxane that disrupts microtubule function. Understanding these mechanisms helps in selecting the most effective treatment regimen and managing side effects.

In vitro cytotoxicity of cabazitaxel in adrenocortical carcinoma cell lines and human adrenocortical carcinoma primary cell cultures☆.Cabazitaxel regimens inhibit the growth of prostate cancer cells and enhances the anti-tumor properties of PEDF with various efficacy and toxicity.ABCB1 Mediates Cabazitaxel-Docetaxel Cross-Resistance in Advanced Prostate Cancer.