Bone metastases in prostate cancer constitute the most frequent cause of systemic failure in treatment, which results in numerous complications and finally leads to patient's death. Pain is one of the first and most important clinical symptoms of bone metastases and can be found among more than 80% of patients. Therefore, the most analgetic effective and simultaneously the least toxic treatment is an important point of therapeutic management in this group of patients. The aim of this prospective clinical trial was a comparison of analgetic effectiveness and toxicity of monotherapy with 153 Sm isotope to combined therapy ( 153 Sm + EBRT) among patients diagnosed with multiple painful bone metastases due to CRPC (mCRPC). 177 patients with mCRPC were included into the prospective randomised clinical trial in which 89 patients were assigned to the 153 Sm isotope monotherapy, while 88 patients were assigned to the combined therapy including 153 Sm isotope therapy and EBRT. All patients were diagnosed (bone scan and X-ray or/and CT or/and MRI) with painful bone metastases (bone pain intensity >= 6 according to VAS classification). The following additional inclusion criteria were established: histologically confirmed adenocarcinoma of prostate, multifocal bone metastases, no prior chemotherapy or palliative radiotherapy to bone. All patients signed informed consent.The combination of the isotope therapy with EBRT was more effective analgetic treatment than isotope therapy alone. The highest pain decline was noticed in the first weeks after treatment termination. In the whole group, a total or partial analgesic effect was observed among 154 (87%) patients while among 23 (13%) patients there was a lack of analgesic effect or even pain intensification.The results of this clinical trial demonstrated that for patients with multiple mCRPC it is recommended to combine the 153 Sm isotope therapy with local EBRT because of a greater analgetic effect. It is important to note that combined therapy did not intensify the toxicity of treatment.
Key words: prostate cancer, bone metastases, isotope therapy, radiotherapy, mCRPCProstate cancer belongs to the most frequently diagnosed malignant tumors among males in the United States and Europe [1,2]. Unfortunately, despite the recent improvement in results of treatment, we are still faced with a significant number of patients with biochemical progression, and subsequent distant metastases. Prostate cancer distant metastases are first diagnosed in the bone, with more than 80% of all patients in the metastatic stage of disease [3,4]. The characteristic feature of prostate cancer bone metastases is their multifocal nature with related pain, which is one of the first symptoms of metastases reported by patients. Pain affects the quality of life, and often does not respond to standard available pharmacological pain therapeutic options [5]. Thus, relief of pain remains the primary goal of therapy. Current treatment options for painful bone lesions include systemic therapy (hormonal therapy,...