The Efficacy of Capesaris to Be Tested On Advanced Prostate Cancer
Castration Resistant Prostate Cancer is that which cannot be treated with the traditional Androgen Deprivation Therapy (ADT) or Hormonal therapy. However, a pharmaceutical company known as GTx is planning to test its new drug Capesaris on men with metastatic castration resistant prostate cancer.
This is to evaluate and establish the potency of the drug on prostate cancer. It is hoped that this will serve as a secondary treatment to provide for such men if the primary hormonal therapy fails. The FDA recently gave GTx a full permission to test the drug. Here are more details on this prostate cancer drug:
GTx, Inc. GTXI +16.13% announced today that the Food and Drug Administration (FDA) removed its Full Clinical Hold on the Company’s Investigational New Drug application for Capesaris(R) following the review by the FDA of the Company’s complete response and its new Phase II clinical protocol. GTx plans to initiate during the third quarter this Phase II open label clinical study of 75 men with metastatic castration resistant prostate cancer to test three lower doses of Capesaris (125 mg, 250 mg and 500 mg) sequentially in cohorts of 25 patients each.
The Phase II clinical study will evaluate the safety and efficacy of Capesaris as secondary hormonal therapy in men with metastatic castration resistant prostate cancer. The study will assess the effect of oral daily doses of Capesaris on serum prostate specific antigen response and prostate cancer progression in men with metastatic castration resistant prostate cancer maintained on primary androgen deprivation therapy (ADT). The study is also designed to provide confirmation of the mechanism of drug action for Capesaris on lowering serum free testosterone levels by increasing serum SHBG. Other key endpoints that will be evaluated in the study include effects on the levels of adrenal androgen precursors, as well as the incidence and frequency of hot flashes and bone loss, which are estrogen deficiency related side effects of ADT. The safety and tolerability of these lower doses of Capesaris will also be evaluated in these subjects, including the incidence of venous thromboembolic events. Click here to read the full extract.
With a drug like Capesaris, it is good news to know that metastatic castration resistant prostate cancer can be dealt with in another way. Apart from its effects on advanced cancer cells of the prostate, its effects on prostate specific antigen are equally minded. If this drug proves to be potent for this advanced stage of cancer, then the medical community as well as victims of prostate cancer would have recorded another breakthrough in prostate cancer medication.
Finally, Secondary hormonal therapy can still be effective to reducing the death rate associated with failed primary treatments. Let’s hope that Capesaris would be among other breakthrough drug after its testing in the coming months.
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