Castration-sensitive prostate cancer, CSPC, is cancer that is controlled by keeping the testosterone level as low as would be expected if the testicles were removed.
Metastatic prostate cancer is prostate cancer that has spread to other parts of the body.
Androgen Deprivation Therapy, ADT, is an antihormone therapy whose main use is in treating prostate cancer. Prostate cancer cells usually require androgen hormones, such as testosterone, to grow. ADT reduces the levels of androgen hormones, with drugs or surgery, to prevent the prostate cancer cells from growing
Current standard of care for metastatic CSPC consists of ADT with either Taxotere, second-generation hormonal therapy, such as Abiraterone and Xtandi or radiotherapy.
About the Study
This was a phase 3 study. Eligible patients were male, aged 18 years or older, diagnosed with metastatic prostate adenocarcinoma, and good quality of life.
Participants were randomly assigned to standard of care (ADT alone or with Taxotere), standard of care plus radiotherapy, standard of care plus Abiraterone plus Prednisone, or standard of care plus radiotherapy plus Abiraterone.
In the overall population, patients assigned to receive Abiraterone had longer time until their disease had progressed and longer survival than patients who did not receive Abiraterone.
In the ADT with Taxotere population, the outcomes were similar.
In the ADT with Taxotere population, harsh side effects occurred in 63% patients who received Abiraterone and in 52% of the patients who did not
Hypertension had the largest difference in occurrence: 22% patients and 13%, respectively.
Addition of Abiraterone to ADT plus Taxotere did not increase the rates of neutropenia, febrile neutropenia, fatigue, or neuropathy compared with ADT plus Taxotere alone.
Combining ADT, Taxotere, and Abiraterone in newly diagnosed metastatic CSPC improved Survival and time until the disease had progressed with a modest increase in toxicity, mostly hypertension.
This triplet therapy could become a standard of care for these patients.
This phase III trial assessed the efficacy and safety of Abiraterone plus Prednisone, with or without radiotherapy, in addition to standard of care (ADT) alone or with Taxotere in 1172 patients with newly diagnosed metastatic CSPC.
ADT, Taxotere, and Abiraterone plus Prednisone, improved Survival and time until the disease had progressed. Without a substantial increase in toxicity compared with the standard of care.
This triple therapy should be considered for patients with newly diagnosed metastatic CSPC with a high metastatic burden who are fit for treatment with Taxotere.
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