A clinical trial to evaluate the effects of samarium-153 lexidronam in patients with metastatic prostate cancer has recently been launched. Approximately 85% of patients with advanced cancers, particularly those of breast, prostate, and lung origin, ultimately experience spread of the original cancer to their bones. Once the cancer cells have infiltrated the bone, the cancer begins to grow and expand within the bone, causing severe pain and bone brittleness. The intense pain caused by bone metastases can greatly impair the quality of life for patients, leading to chronic suffering and immobility. Additionally, bone brittleness caused by the cancer can lead to bone fractures, also resulting in extreme pain, extended convalescence, anxiety, depression, and excessive medical costs. Often, chemotherapy, radiation and/or hormone therapy are utilized to shrink the cancer in order to alleviate or lessen the pain. Although these treatments often provide initial relief, cancer cells tend to become resistant to these forms of treatment. Thus, research is ongoing in an attempt to provide novel effective therapies to be utilized for the treatment of bone metastases.

Samarium-153 lexidronam, a type of radionuclide therapy, is currently approved by the FDA to treat pain from bone metastases. Radionuclides are substances that spontaneously emit radiation. Samarium-153 lexidronam has been chemically developed in a laboratory to bind to cancer cells specifically in the bone. Once samarium-153 lexidronam has bound to the cancer cells, it delivers radiation to the cancer, alleviating pain. The side effects caused by samarium-153 lexidronam have been shown to be minimal.

The clinical trial currently underway has been launched to further evaluate samarium-153 lexidronam for the treatment of patients with advanced prostate cancer that has spread to their bones. The purpose of the study is to determine whether early treatment of bone metastases, before they are painful, will delay the onset of pain. The study will also be used to evaluate the effect of the treatment on disease progression. Three multicenter, controlled clinical trials evaluating samarium-153 lexidronam have been conducted to date. In all of these trials, the majority of patients receiving samarium-153 lexidronam for the treatment of bone metastases reported a significant reduction in their pain following treatment. In addition, patients were able to safely and effectively receive samarium-153 lexidronam in combination with hormonal therapy.

Patients with prostate cancer involving the bone may wish to speak with their physician about the risks and benefits of participation in this clinical trial. Information regarding the location of clinical trials evaluating samarium-153 lexidronam can be found in a comprehensive, easy-to-use on-line listing service provided by

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