Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial

Investigating Treatments for Hormone-Sensitive Prostate Cancer

Recruiting
18 years - 100 years
Male
Phase N/A
1 Location

Brief description of study.

This randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with hormone-sensitive prostate cancer previously treated with docetaxel that has spread to other parts of the body.

Detailed description of study

The purpose of this study is to assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with castration-resistant prostate cancer (CRPC) that have previously received docetaxel and androgen deprivation therapy (ADT) for hormone-sensitive prostate cancer (HSPC) can improve progression-free survival (PFS) compared to abiraterone acetate alone.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: prostate cancer
  • Age: 18 years - 100 years
  • Gender: Male

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)
  • Previous chemotherapy with at least 3 cycles of docetaxel for hormone-sensitive metastatic prostate cancer

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1805551737 (EA8153)

This study investigates treatments for hormone-sensitive prostate cancer that has spread to other parts of the body. The purpose is to see if adding cabazitaxel to abiraterone acetate and antiandrogen therapy can improve progression-free survival in patients who have already been treated with docetaxel and androgen deprivation therapy. Hormone-sensitive prostate cancer means the cancer responds to treatments that lower testosterone.

Participants will receive either abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone. Cabazitaxel is a chemotherapy drug, and prednisone is a steroid that can help manage side effects. The study aims to compare the effectiveness of these treatments in controlling cancer progression.

  • Who can participate: Men with a confirmed diagnosis of prostate cancer who have previously undergone at least 3 cycles of docetaxel chemotherapy for metastatic hormone-sensitive prostate cancer are eligible.
  • Study details: Participants will be assigned to receive either abiraterone acetate and antiandrogen therapy alone or with additional cabazitaxel and prednisone. A placebo is not used in this study.

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