Impact of Prophylactic Bone Radiation Therapy in Patients With Bone Metastases.

Impact of Prophylactic Bone Radiation Therapy on Morbidity and Mortality in Patients With Asymptomatic Bone Metastases and an Intermediate Risk of Bone Events.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07733193

Acronym

PREBONE

Enrollment

154

Registered

2026-07-29

Start date

2026-09-01

Completion date

2030-11-01

Last updated

2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases

Keywords

prophylactic radiation, bone metastases, pain

Brief summary

Radiation therapy is a common treatment for painful bone metastases, proving effective in 1 to 2/3 of cases after 1 to 10 sessions, with stereotactic body radiation therapy (SBRT) likely offering superior results. Radiation therapy is also used to prevent bone events, although its use is not standardized; the decision to administer it is made by clinicians or through multidisciplinary team (MDT) discussions. Recently, it has been shown that preventive radiation therapy can reduce the risk of skeletal-related events (SREs) in patients at high risk for bone events. The objective is to compare active surveillance with preventive radiation therapy in patients at intermediate risk for bone events.

Interventions

RADIATIONprophylactic radiation

Patients will undergo propthylactic radiation on bone metastases

DRUGstandard of care

Patients will have systemic treatment on the standard of care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Men or women, 18 years of age or older * Patients with solid cancer and bone metastases * Patients with bone lesions considered to be at intermediate risk for skeletal-related events (SINS score between 7 and 12, Mirels 8) or patients with lesions accompanied by Grade 1 epiduritis (Bilsky) * Enrolled in or covered by a social insurance program * Patients with an estimated life expectancy of more than 6 months

Exclusion criteria

* Hematologic disease * Patients with a lesion at high risk for skeletal-related events (SINS score of 13 or higher, MIRELS score of 9 or higher, or a multidisciplinary team (MDT) recommendation that surgery is necessary) * Patients with pain secondary to bone lesions requiring radiation therapy * Contraindication to radiation therapy due to a history of radiation therapy at the same site or a condition contraindicating radiation therapy * Pregnant or breastfeeding women * Contraindication to MRI in cases of spinal lesions; contrast-enhanced CT scan * Patients unable to understand the study for any reason or to comply with the trial requirements (language, psychological, geographic issues, etc.) * Patients under legal guardianship or conservatorship * Patients classified as WHO 3 or 4

Design outcomes

Primary

Measure	Time frame	Description
Bone event	one year	rate of bone event in the two arms

Countries

France

Contacts

CONTACTSebastien Thureau, MD, PhD

sebastien.thureau@chb.unicancer.fr+0232082985

CONTACTDoriane Richard, PhD

doriane.richard@chb.unicancer.fr+33232082985

STUDY_DIRECTORSebastien Thureau, MD, PhD

Centre Henri Becquerel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026