CClinicalTrials.gg
Not yet recruitingNCT07733193PREBONEUpdated Jul 29, 2026

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

A Phase 3 interventional study of prophylactic radiation and standard of care in Bone Metastases, sponsored by Centre Henri Becquerel. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Centre Henri Becquerel · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Bone Metastases

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Keywords

  • prophylactic radiation
  • bone metastases
  • pain
03

In context

Pain

2,219 studies on the registry are indexed under Pain; 917 are open to participants now.

This study's planned enrollment of 154 is above the median of 70 across 1,904 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Centre Henri Becquerel is the lead sponsor of 57 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
154 participants (estimated)

Study arms

  • Active comparator
    Standard arm

    no bone radiation for patient allocated in this arm

    Drug: standard of care

  • Experimental
    Prophylactic radiation

    patient undergo prophylactic radiation on bone metastases

    Radiation: prophylactic radiation

Interventions

  • Radiationprophylactic radiation

    Patients will undergo propthylactic radiation on bone metastases

  • Drugstandard of care

    Patients will have systemic treatment on the standard of care

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What researchers measure

Primary outcomes

  1. Bone event

    rate of bone event in the two arms

    Time frame: one year

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Study locations

2 sites
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07733193
Lead sponsor
Centre Henri Becquerel
Responsible party
Sponsor
First posted
Jul 29, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2029 (estimated)
Completion
Nov 1, 2030 (estimated)
Last update
Jul 29, 2026

Study contacts

Sebastien Thureau, MD, PhD
Contact
sebastien.thureau@chb.unicancer.fr
+0232082985
Doriane Richard, PhD
Contact
doriane.richard@chb.unicancer.fr
+33232082985
Sebastien Thureau, MD, PhD
study director · Centre Henri Becquerel

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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