Bone MetastasesPhase 2pRevenTNCT07540650
Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers
A Phase 2 study testing Prophylactic External Beam Radiotherapy in people with Bone Metastases and Metastatic Solid Tumor, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This is a prospective, randomized, single-center clinical trial evaluating whether early prophylactic radiotherapy to high-risk asymptomatic or minimally symptomatic bone metastases reduces the 1-year rate of skeletal-related events (SREs) in patients with metastatic solid cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases, Metastatic Solid Tumor
- What is being tested?
- Prophylactic External Beam Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSlovenia
- Study dates
- 2 Jun 2026to Feb 2029
- Phase
- Phase 2
- 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
- Age ≥18 years
- Histologically confirmed solid malignancy
- Metastatic disease confirmed by imaging (CT, MRI, or PET-CT)
- Presence of up to five high-risk bone metastases
- High-risk bone metastases defined according to protocol criteria
- Asymptomatic or minimally symptomatic bone metastases (not requiring opioid analgesics)
- ECOG performance status 0-2
- Ability to provide written informed consent
Who cannot join
- Prior radiotherapy to the index bone metastases preventing safe treatment planning
- Symptomatic bone metastases requiring immediate palliative radiotherapy
- Evidence of spinal cord compression
- Bone metastases causing significant pain requiring opioid analgesics
- Oligometastatic disease suitable for radical treatment
- Leptomeningeal disease
Show all 9Show fewer
- ECOG performance status ≥3
- Life expectancy less than 3 months
- Any condition that, in the investigator's opinion, would interfere with study participation or assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
Institute of Oncology Ljubljana
Ljubljana, 1000
Eva Ćirić, MD, +38615879623, eciric@onko-i.si
Klavdija Korošec, +38631630065, kkorosec@onko-i.si
About this study
Official title: A Randomized Controlled Trial of Early Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers
This is a prospective, randomized, single-center clinical trial evaluating whether early prophylactic radiotherapy to high-risk asymptomatic or minimally symptomatic bone metastases reduces the 1-year rate of skeletal-related events (SREs) in patients with metastatic solid cancers. Patients will be randomized in a 1:1 ratio to receive either standard of care systemic therapy or observation, or prophylactic radiotherapy in addition to standard of care. The primary endpoint is the 1-year rate of SREs. Secondary endpoints include adverse events, quality of life, economic burden, pain-free survival, and overall survival.
Read the detailed description
Bone metastases are a common complication in patients with metastatic solid cancers and are associated with significant morbidity, including skeletal-related events (SREs) such as pathological fractures, spinal cord compression, and severe pain requiring intervention. While palliative radiotherapy is an established treatment for symptomatic bone metastases, the role of prophylactic radiotherapy in asymptomatic or minimally symptomatic high-risk lesions remains insufficiently defined.
This prospective, randomized, single-center phase II clinical trial evaluates the effectiveness of early prophylactic radiotherapy in reducing the incidence of SREs. Eligible patients with metastatic solid cancers and up to five high-risk asymptomatic or minimally symptomatic bone metastases will be randomized in a 1:1 ratio into two groups. The control group will receive standard of care systemic therapy or observation according to tumor type and clinical guidelines. The intervention group will receive prophylactic external-beam radiotherapy (25 Gy in 5 fractions) to selected high-risk bone metastases in addition to standard of care.
Patients will be followed from baseline up to 12 months, with assessments conducted at predefined intervals. Study outcomes include the incidence of SREs, adverse events (graded according to CTCAE), patient-reported outcomes using validated questionnaires (EORTC QLQ-C30, EQ-5D-5L, BPI), economic burden, pain-free survival, and overall survival.
This study aims to determine whether early radiotherapy intervention can prevent skeletal complications, reduce healthcare burden, and improve patient outcomes in metastatic bone disease.
- Conditions
- Bone Metastases, Metastatic Solid Tumor
- Being tested
- Prophylactic External Beam Radiotherapy, Standard of Care
- Keywords
- prophylactic radiotherapy, early radiotherapy
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic External Beam RadiotherapyRadiation
External beam radiotherapy delivered to up to five high-risk asymptomatic or minimally symptomatic bone metastases at a total dose of 25 Gy in 5 fractions.
Standard of CareOther
Systemic therapy or observation according to tumor type and clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic Radiotherapy + Standard of Care | Experimental | Participants receive prophylactic external-beam radiotherapy (25 Gy in 5 fractions) to up to five high-risk asymptomatic or minimally symptomatic bone metastases, in addition to standard of care systemic therapy or observation. Receives: Radiation: Prophylactic External Beam Radiotherapy; Other: Standard of Care |
| Standard of Care | Active comparator | Participants receive standard of care systemic therapy or observation according to tumor type and clinical guidelines, without prophylactic radiotherapy. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year rate of skeletal-related events (SREs)
Number of participants experiencing at least one skeletal-related event (pathological fracture, spinal cord compression, need for radiation to bone, need for surgery to bone, or tumor-related hypercalcemia) within 12 months after randomization.
Measured: From randomization to 12 months after randomization
Secondary outcomes (7)
Incidence of adverse events
Adverse events assessed and graded according to CTCAE version 6.0
Measured: Up to 12 months after randomization
EORTC QLQ-C30 global health status score
EORTC QLQ-C30 global health status score at each assessment time point (range: 0-100; higher scores indicate better quality of life).
Measured: Baseline, 3 months, 6 months, and 12 months after randomization
EQ-5D-5L index score
EQ-5D-5L index score at each assessment time point (range typically from <0 to 1; higher values indicate better health status).
Measured: Baseline and follow-up visits up to 12 months after randomization
Brief Pain Inventory (BPI) pain intensity score
Pain intensity score measured using the Brief Pain Inventory (scale 0-10; higher scores indicate worse pain).
Measured: Baseline and follow-up visits up to 12 months after randomization
Pain-free survival
Time from randomization to first occurrence of pain requiring opioid analgesics or death from any cause, whichever occurs first.
Measured: From randomization to 12 months after randomization
Overall survival
Time from randomization to death from any cause.
Measured: From randomization to 12 months after randomization
Healthcare resource utilization
Number and duration of hospitalizations, number of outpatient visits, and associated healthcare costs during the study period.
Measured: From randomization to 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start2 Jun 2026
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to one of two parallel groups: 1. standard of care systemic therapy or observation, or 2. prophylactic external-beam radiotherapy in addition to standard of care systemic therapy or observation.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540650
- Sponsor's protocol ID
- ORI2025-23
- Acronym
- pRevenT
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Early Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers
- ClinicalTrials.gov ID
- NCT07540650
- Acronym / sponsor ID
- pRevenT / ORI2025-23
- Conditions
- Bone Metastases, Metastatic Solid Tumor
- Keywords
- prophylactic radiotherapy, early radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 20 Apr 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.
This is a prospective, randomized, single-center clinical trial evaluating whether early prophylactic radiotherapy to high-risk asymptomatic or minimally symptomatic bone metastases reduces the 1-year rate of skeletal-related events (SREs) in patients with metastatic solid cancers. Patients will be randomized in a 1:1 ratio to receive either standard of care systemic therapy or observation, or prophylactic radiotherapy in addition to standard of care. The primary endpoint is the 1-year rate of SREs. Secondary endpoints include adverse events, quality of life, economic burden, pain-free survival, and overall survival.
Detailed description
Bone metastases are a common complication in patients with metastatic solid cancers and are associated with significant morbidity, including skeletal-related events (SREs) such as pathological fractures, spinal cord compression, and severe pain requiring intervention. While palliative radiotherapy is an established treatment for symptomatic bone metastases, the role of prophylactic radiotherapy in asymptomatic or minimally symptomatic high-risk lesions remains insufficiently defined.
This prospective, randomized, single-center phase II clinical trial evaluates the effectiveness of early prophylactic radiotherapy in reducing the incidence of SREs. Eligible patients with metastatic solid cancers and up to five high-risk asymptomatic or minimally symptomatic bone metastases will be randomized in a 1:1 ratio into two groups. The control group will receive standard of care systemic therapy or observation according to tumor type and clinical guidelines. The intervention group will receive prophylactic external-beam radiotherapy (25 Gy in 5 fractions) to selected high-risk bone metastases in addition to standard of care.
Patients will be followed from baseline up to 12 months, with assessments conducted at predefined intervals. Study outcomes include the incidence of SREs, adverse events (graded according to CTCAE), patient-reported outcomes using validated questionnaires (EORTC QLQ-C30, EQ-5D-5L, BPI), economic burden, pain-free survival, and overall survival.
This study aims to determine whether early radiotherapy intervention can prevent skeletal complications, reduce healthcare burden, and improve patient outcomes in metastatic bone disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to one of two parallel groups: 1. standard of care systemic therapy or observation, or 2. prophylactic external-beam radiotherapy in addition to standard of care systemic therapy or observation.
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Radiotherapy + Standard of Care | Experimental | Radiation: Prophylactic External Beam Radiotherapy, Other: Standard of CareParticipants receive prophylactic external-beam radiotherapy (25 Gy in 5 fractions) to up to five high-risk asymptomatic or minimally symptomatic bone metastases, in addition to standard of care systemic therapy or observation. |
| Standard of Care | Active comparator | Other: Standard of CareParticipants receive standard of care systemic therapy or observation according to tumor type and clinical guidelines, without prophylactic radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Histologically confirmed solid malignancy
- Metastatic disease confirmed by imaging (CT, MRI, or PET-CT)
- Presence of up to five high-risk bone metastases
- High-risk bone metastases defined according to protocol criteria
Key exclusion criteria (9 listed)
- Prior radiotherapy to the index bone metastases preventing safe treatment planning
- Symptomatic bone metastases requiring immediate palliative radiotherapy
- Evidence of spinal cord compression
- Bone metastases causing significant pain requiring opioid analgesics
- Oligometastatic disease suitable for radical treatment
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 External Beam RadiotherapyExternal beam radiotherapy delivered to up to five high-risk asymptomatic or minimally symptomatic bone metastases at a total dose of 25 Gy in 5 fractions. | Radiation | Prophylactic Radiotherapy + Standard of Care |
| Standard of CareSystemic therapy or observation according to tumor type and clinical guidelines. | Other | Prophylactic Radiotherapy + Standard of Care, Standard of Care |
Primary outcome
1-year rate of skeletal-related events (SREs)
Time frame: From randomization to 12 months after randomization
Number of participants experiencing at least one skeletal-related event (pathological fracture, spinal cord compression, need for radiation to bone, need for surgery to bone, or tumor-related hypercalcemia) within 12 months after randomization.
7 secondary outcomes
Incidence of adverse events
Time frame: Up to 12 months after randomization
EORTC QLQ-C30 global health status score
Time frame: Baseline, 3 months, 6 months, and 12 months after randomization
EQ-5D-5L index score
Time frame: Baseline and follow-up visits up to 12 months after randomization
Brief Pain Inventory (BPI) pain intensity score
Time frame: Baseline and follow-up visits up to 12 months after randomization
Pain-free survival
Time frame: From randomization to 12 months after randomization
Overall survival
Time frame: From randomization to 12 months after randomization
Healthcare resource utilization
Time frame: From randomization to 12 months after randomization
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 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prophylactic External Beam Radiotherapy in people with Bone Metastases and Metastatic Solid Tumor, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 8 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Eva Ćirić, MD (+38615879623, eciric@onko-i.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year rate of skeletal-related events (SREs) (time frame: From randomization to 12 months after randomization). 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 9 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.