Trial Information

Challenging the Paradigm in Pain Relief for Advanced Breast and Prostate Cancer Patients With Vertebral Metastasis: Vertebral Augmentation With Cement Plus Radiotherapy Versus Radiotherapy. A Randomized, Prospective, Double Blind Pilot Study

Included patients presenting with spinal metastasis secondary to breast or prostate cancer
are randomized to two groups, intervention and control. Both groups receive standard
radiotherapy, which is currently the gold standard of care for such patients. The
intervention group will also receive a vertebroplasty [single or multiple level(s)], while
the control group will receive a simulated vertebroplasty, where local anesthesia and gentle
hand manipulation will be used but the vertebra will not be accessed. The primary outcome
is pain relief, though other factors such as quality of life and pain medications will also
be evaluated.

There will be an interim analysis after half of the patients have been treated with a
follow-up of 3 months. In the analysis, comparisons will be made between the two groups and
each patient's individual progress will also be analyzed.