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Evaluation of the Biological Safety and Clinical Efficacy of 177 Lu-EDTMP for Bone Pain Palliation in Metastatic Prostate Cancer (PhaseI/II Clinical Trial)
Closed for proposals
Project Type
Project Code
E13033CRP
1412Approved Date
Status
Start Date
Expected End Date
Completed Date
4 April 2012Description
Prostate cancer is currently one of the most common malignancies worldwide. About 50-70% of patients present with locally advanced stage and about 15-30% have bone metastases at the time of diagnosis. In advanced stage of the disease, cancer spread to the skeleton occurs in a majority of patients, with skeletal metastases being predominantly osteoblastic in nature. Disseminated skeletal involvement results in hypercalcemia, anaemia, factures and spinal cord compression as well as intractable pain, complications that may profoundly impair quality of life. Radionuclide Therapy is an alternative modality to "Hemibody" Radiation Therapy in this particular group of patients. Treatment with bone seeking beta-emitting radiopharmaceuticals has been shown to reduce pain for a prolonged period and to improve quality of life with no serious side effects. 177Lu-EDTMP has a very good potential for use in in-vivo therapy, because of its f'avourable decay characteristics. Effective cancer management requires standardizing and coordinating treatment protocols and by making available economically affordable therapies. Our approach will utilize available capacities in Member States. This CRP will generate know- how and expertise in participating Medical Institutions to explore the potential therapeutic efficacy of this promising bone pain palliating agent. The overall objective of this CRP aims at evaluating the biological safety and clinical efficacy of 177Lu-EDTMP for bone pain palliation in metastatie prostate cancer in a Phase I and Phase II clinical trial.
Objectives
1.Demonstrate the feasibility, biological safety and clinical efficacy of the 177Lu-EDTMP to relief bone pain in patients with disseminated metastatic prostate cancer not responsive to hormone therapy.
2. To improve access to cost effective treatment by developing appropriate infrastructure, radio pharmacy and clinical institutions to promote effective use of targeted radionuclide therapy in developing member states.
Specific objectives
Asses the maximum tolerated dose and toxicity profile and assess the clinical effectiveness in palliating bone pain in a randomized trial by comparing two levels of injected activities of Lu-177 to patients with breast cancer or prostate cancer.
Assess the efficacy and safety of 177Lu-EDTMP for bone pain palliation in patients with breast cancer and hormone refractory prostate cancer with bone metastases.
Impact
Improve cancer patients' management.
Enhance knowledge of professionals involved (Physicians, medical physicists technologists) in conducting internal dosimetry and performing cancer therapy using unsealed radioisotopes.
Create and enhance capacities to achieve self reliance with respect to the production and delivery of therapeutic radiopharmaceuticals
Relevance
The CRP is highly relevance as it tackles the need to provide a palliative care to cancer patients,
It in addition enhanced professionals' knowledge and created capacities to conduct more advanced targeted molecular therapies using tumour-targeting peptides (e.g. somatostatin receptors analogues) for the treatment of cancers expressing SSA.