Comparing Radiation Therapy to Usual Treatment for Patients With High-Risk Bone Metastases That Are Not Causing Pain, PREEMPT Trial (NCT06745024)
Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)
🩺 Plain-English Summary (8th-Grade Level)
This phase III trial compares the effect of adding radiation therapy to usual treatment on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms, such as pain (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger). These bone metastases appear to be at higher risk of complications such as fracture, spinal cord compression, and/or pain warranting surgery or radiation treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. The total dose of radiation can be delivered in a single day or divided in smaller doses for up to 5 days of total treatment. Usual treatment for asymptomatic bone metastases may include drugs that prevent bone loss, in addition to the treatment for the primary cancer or observation (which means no treatment until symptoms appear). Evidence has shown that preventative radiation therapy may be effective in lowering the number of bone metastases-related complications, however, it is not known if this approach is superior to usual care. Adding radiation therapy to usual treatment may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases.
Who can join: Review the eligibility criteria below.
Location: Fairbanks Memorial Hospital — Fairbanks, Alaska
Age range: 18 Years
🧪 Interventions in This Study
- Best Practice (OTHER)
- Biospecimen Collection (PROCEDURE)
- Bone Metastases Treatment (OTHER)
- Computed Tomography (PROCEDURE)
- Conventional Radiotherapy (PROCEDURE)
- Magnetic Resonance Imaging (PROCEDURE)
- Patient Observation (OTHER)
- Questionnaire Administration (OTHER)
- Stereotactic Body Radiation Therapy (RADIATION)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (626 Sites)
Showing the first 25 of 626 sites.
- Fairbanks Memorial Hospital — Fairbanks, Alaska
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- Cancer Center at Saint Joseph's — Phoenix, Arizona
- Banner-University Medical Center Phoenix — Phoenix, Arizona
- Banner University Medical Center - Tucson — Tucson, Arizona
- University of Arizona Cancer Center-North Campus — Tucson, Arizona
- Kaiser Permanente-Anaheim — Anaheim, California
- Kaiser Permanente-Deer Valley Medical Center — Antioch, California
- Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California
- Sutter Auburn Faith Hospital — Auburn, California
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California
- AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California
- Kaiser Permanente-Bellflower — Bellflower, California
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California
- Mills-Peninsula Medical Center — Burlingame, California
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California
- Mercy Cancer Center - Carmichael — Carmichael, California
- Mercy San Juan Medical Center — Carmichael, California
- Eden Hospital Medical Center — Castro Valley, California
- City of Hope Corona — Corona, California
- City of Hope Comprehensive Cancer Center — Duarte, California
- Kaiser Permanente Dublin — Dublin, California
- Mercy Cancer Center - Elk Grove — Elk Grove, California
- UC San Diego Health System - Encinitas — Encinitas, California
- Kaiser Permanente-Fremont — Fremont, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.