Prophylactic Radiotherapy of Minimally Symptomatic Spinal Disease (PROMISSeD Trial)

What this Trial Is About

Researchers are investigating the impact of early prophylactic radiotherapy on patients with minimally symptomatic spinal metastases from solid tumors. This study aims to find out if upfront radiation treatment can lower the risk of skeletal-related events, such as fractures or hospitalizations, compared to standard care or delayed radiation after symptoms develop. The trial is conducted in phases 1 and 2 and focuses on patients with high-risk bone metastases that are either asymptomatic or cause minimal symptoms without opioid use. Participants are randomly assigned to one of two groups. One group receives standard systemic therapy, including chemotherapy, targeted therapy, immunotherapy, or hormonal therapy, with radiation only if symptoms worsen. The other group receives upfront prophylactic radiation targeting up to five highest-risk bone metastases in the spine, using various radiation techniques tailored by the treating oncologist. Both groups continue systemic therapy as determined by their oncologists. During the study, patients will be monitored for skeletal-related events over one year, including hospitalizations due to these events. Researchers will also assess pain-related quality of life, overall health utilities, pain-free survival, overall survival, and any adverse effects at 3, 6, and 12 months. The trial involves routine imaging and clinical assessments to track disease progression and treatment impact. Participation duration is about one year with ongoing evaluations to understand the benefits and risks of early radiation in this patient group.

Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease