Bone MetastasesPhase 3PREBONENCT07733193
Impact of Prophylactic Bone Radiation Therapy in Patients With Bone Metastases.
A Phase 3 study testing prophylactic radiation in people with Bone Metastases, run by Centre Henri Becquerel at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- prophylactic radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2026to 1 Nov 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Institut de Cancérologie de Lorraine
Nancy
Jean-Christophe Faivre, MD, +33383598349, jc.faivre@nancy.unicancer.fr
Centre Henri Becquerel
Rouen
Sebastien Thureau, MD, PhD, +33232082985, sebastien.thureau@chb.unicancer.fr
About this study
Official title: Impact of Prophylactic Bone Radiation Therapy on Morbidity and Mortality in Patients With Asymptomatic Bone Metastases and an Intermediate Risk of Bone Events.
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.
- Conditions
- Bone Metastases
- Being tested
- prophylactic radiation, standard of care
- Keywords
- prophylactic radiation, bone metastases, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic radiationRadiation
Patients will undergo propthylactic radiation on bone metastases
standard of careDrug
Patients will have systemic treatment on the standard of care
| Study group | Role | What they receive |
|---|---|---|
| Standard arm | Active comparator | no bone radiation for patient allocated in this arm Receives: Drug: standard of care |
| Prophylactic radiation | Experimental | patient undergo prophylactic radiation on bone metastases Receives: Radiation: prophylactic radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone event
rate of bone event in the two arms
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien Thureau, MD, PhD, Study director, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733193
- Sponsor's protocol ID
- CHB25.03
- Other IDs
- 2025-A01328-41
- Acronym
- PREBONE
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prophylactic Bone Radiation Therapy on Morbidity and Mortality in Patients With Asymptomatic Bone Metastases and an Intermediate Risk of Bone Events.
- ClinicalTrials.gov ID
- NCT07733193
- Acronym / sponsor ID
- PREBONE / CHB25.03
- Conditions
- Bone Metastases
- Keywords
- prophylactic radiation, bone metastases, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard arm | Active comparator | Drug: standard of careno bone radiation for patient allocated in this arm |
| Prophylactic radiation | Experimental | Radiation: prophylactic radiationpatient undergo prophylactic radiation on bone metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prophylactic radiationPatients will undergo propthylactic radiation on bone metastases | Radiation | Prophylactic radiation |
| standard of carePatients will have systemic treatment on the standard of care | Drug | Standard arm |
Primary outcome
Bone event
Time frame: one year
rate of bone event in the two arms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Bone Metastases
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 2
Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma
Osteogenic Sarcoma Recurrent
RecruitingObservational study
Change in Fat Fraction Quantification Before and After Treatment in Bone Metastases
Neoplasm Metastasis / Bone and Bones
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastien Thureau, MD, PhD study director
Centre Henri Becquerel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing prophylactic radiation in people with Bone Metastases, run by Centre Henri Becquerel at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastien Thureau, MD, PhD (+0232082985, sebastien.thureau@chb.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone event (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.