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pRevenT: Randomized controlled study of (early) prophylactic irradiation to prevent bone complications in patients with metastatic solid tumors

 

Bone metastases are the third most common metastatic site, mostly originating from prostate, breast, and lung cancers. Around 1.5 million people live with bone metastases globally, and half will develop skeletal-related events (SREs)—such as malignant bone pain, pathologic fractures, or spinal cord compression—within two years of diagnosis. These complications lead to significant morbidity, decreased quality of life (QoL), and increased mortality, often requiring urgent surgery or radiotherapy. Palliative radiotherapy is the standard treatment for symptomatic bone metastases, being short, cost-effective, and safe. Prophylactic radiotherapy may prevent progression in high-risk asymptomatic lesions, reduce the incidence of SREs, and avoid hospitalisation or surgery, thereby improving QoL.

With improved systemic therapies and patient survival, managing SREs has become more critical. However, only two studies have evaluated prophylactic radiotherapy. One retrospective study showed a delay in SRE onset from 25 to 81 months, while a phase II trial found a reduction in 1-year SREs from 29% to 1.5% and improved survival. We will conduct a randomised single-centre phase II clinical trial testing whether prophylactic radiotherapy to high-risk, uncomplicated bone metastases in polymetastatic patients reduces SRE occurrence. Patients will be randomised 1:1 by histology. Group 1 will receive standard care; Group 2 will receive additional prophylactic radiotherapy to high-risk metastases that are asymptomatic or mildly symptomatic (no opioid use). The primary outcome is the 1-year SRE rate, including bone pain, spinal compression, fractures, or need for surgery/radiotherapy.

The binary outcome superiority trial requires 66 patients to detect a reduction from 30% to 5% SRE rate with 80% power. Allowing for 20% dropout, 80 patients will be enrolled over 24 months, starting after regulatory approvals. This will be the first clinical study in Slovenia assessing early prophylactic radiotherapy in this population, with potential to influence both national and international clinical practice.