This trial is evaluating whether Abiraterone Acetate will improve 1 primary outcome and 5 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Time from starting treatment until progression, assessed up to 6 months.
This trial requires 60 total participants across 2 different treatment groups
This trial involves 2 different treatments. Abiraterone Acetate is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
More than 250,000 men become prostate cancer survivors in a year, and approximately 18,000 men die of prostate cancer each year. Men who survive prostate cancer have a 30% chance of dying of prostate cancer. The American men with prostate cancer have an average survival of 6 years.
Prostate cancer is a cancer that forms in the prostate and typically forms in men over the age of 50. It is frequently painful and often appears as an enlargement of the prostate gland. Prostatitis, a chronic inflammation of the prostate gland, is not the same disease, but the terms are often used interchangeably. Prostatitis is a noncancerous disorder that can cause persistent and chronic inflammation. It often begins as an acute, noncancerous inflammation, generally caused by a viral infection or bacterial infection. Prostatitis may progress to cancer in 10-15% of cases.
What causes [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is not completely understood, but many factors have been identified that can affect the risk of getting this cancer, especially with African-American men, including exposure to pesticides, a family history of prostate cancer, a history of diabetes, and obesity. Some environmental and lifestyle factors that are thought to increase risk include drinking alcohol, increased body size, physical activity, and exposure to high-risk sexual behaviors. Genetic and racial differences in prostate cancer are also well-documented and may play an important role.
There is no cure for prostate cancer, so treatment is most often focused on symptom management and is highly dependent on the specific patient. A number of treatments (such as hormonal therapy and chemotherapy) are used as part of the treatment.
Although most signs and symptoms appear as part and only after diagnosis of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), a few may be present before diagnosis, for example bleeding from the prostate, constipation or weakness. Abnormal sensations such as burning with urination, painful or sudden urination after having gone a while without feeling anything, decreased sex drive, or nocturia are also part of the prostate cancer diagnosis. Other symptoms that may warrant discussion with a doctor include unexplained weight loss and sudden muscle pain. Some symptoms such as changes in vision can be part of more serious conditions with similar symptoms – so-called 'false negatives' – that may have contributed to the diagnosis of prostate cancer.
The common side effects of AA administration can be avoided by regular clinical practice. In conclusion, with proper adjustment of the initial dose of AA the most common, non-severe side effects may be treated with only a small adjustment. However, the dose adjustment would not diminish the therapeutic effect of the drug. We conclude that AA can be used as an alternative therapy for hormone refractory prostate cancer.
Based on the results of this study, it can be concluded that [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) can not only be explained by some type of infection or exposure to an environmental factor. The study proposes another explanation of prostate cancer: the theory of the environmental component hypothesis (ECHP). The ECHP postulates that prostate development can be influenced by a variety of factors. In the case of prostate cancer, it seems reasonable to postulate that the most powerful carcinogenic factor is the exposure to tobacco. However, prostate cancer is a complex disease with a complex etiology, and other environmental factors are not completely excluded in causation. The main task of the researchers was the evaluation of the relationship of prostate cancer with other diseases.
The safety profile of the standard 25 mg/week dose was excellent and there was a good tolerability profile with good or very good scores on most of the items across all the clinical events evaluated. In one clinical scenario, dose escalation to 50 mg/week did not influence the tolerability profile, with similar scores across all clinical events evaluated as for the 25 mg standard dose.
There are no randomized, controlled clinical trials currently available comparing the efficacy and safety of abiraterone acetate treatment with or without 5-alpha-reductase inhibitors in Japanese patients. Therefore, the therapeutic efficacy of the drug in this patient group has not yet been established. Future global randomized, controlled clinical trials are required to provide important information for Japanese patients.
Although a substantial portion of both relatives in the families examined exhibited PCa in either the first or second degree, the prevalence of PCa was not higher in the family members. Furthermore, all of the men in the families with reported PCa had a family history of PCa and/or a PCa family history. Therefore, hereditary contribution to PCa appears to be low.