Spine MetastasesPhase 1/2PROMISSeDNCT05534321
Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease
A Phase 1/2 study testing Prophylactic Radiotherapy in people with Spine Metastases, run by Baptist Health South Florida at 1 site in United States.
Trial summary
Early palliative care has been shown to improve the quality of life and even survival for patients with metastatic cancer. More and more supportive oncology teams in cancer centers now advocate for early integration of radiation therapy (RT) in a patient's palliative management course. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Metastases
- What is being tested?
- Prophylactic Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2022to Sep 2028
- Phase
- Phase 1/2
- 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
- Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging.
- Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as:
- Bulkiest sites of spinal osseous disease ≥ 2cm,
- Disease at junctional levels, including the thoracic apex (Occiput to C2, C7-T1, T12-L2, and L5- S1)
- Disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints.
- Vertebral body compression deformity > 50%.
Show all 10Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
- Age ≥ 18 years.
- Able to provide informed consent.
- Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating.
Who cannot join
- Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
- Serious medical co-morbidities precluding RT.
- Pregnant or lactating women.
- Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.
- Leptomeningeal disease.
- Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baptist Health Herbert Wertheim Cancer Institute
Miami, Florida, 33176
Rupesh Kotecha, MD, 786-596-2000, RupeshK@baptisthealth.net
Rupesh Kotecha, MD
About this study
Official title: Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease (PROMISSeD Trial)
Early palliative care has been shown to improve the quality of life and even survival for patients with metastatic cancer. More and more supportive oncology teams in cancer centers now advocate for early integration of radiation therapy (RT) in a patient's palliative management course. While multiple randomized studies have evaluated the efficacy of different RT regimens in the treatment of symptomatic bone lesions, few studies have examined the impact of early, upfront RT for asymptomatic or minimally symptomatic (non- opioid dependent) spine metastases and its efficacy in preventing skeletal-related events (SREs). Since the pathophysiology of spinal metastatic disease is distinct from other bony metastatic disease, the proposed trial seeks to understand whether it is beneficial to patients with minimally symptomatic disease to undergo upfront RT to reduce the risks of SREs and their sequelae, including hospitalizations.
- Conditions
- Spine Metastases
- Being tested
- Prophylactic Radiotherapy, Standard of care systemic therapy
- Keywords
- Radiotherapy (RT), Palliative radiotherapy, High-risk asymptomatic spine metastases, Minimal asymptomatic spine metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic RadiotherapyRadiation
Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, three-dimensional conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT), and stereotactic radiosurgery/stereotactic body radiation therapy (SRS/SBRT) techniques may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.
Standard of care systemic therapyDrug
Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Systemic Therapy or Surveillance | Active comparator | Patients randomized to arm 1 will undergo appropriate systemic therapy as determined by their oncology team. These patients will either continue the current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to arm 1, these patients may also undergo palliative radiation therapy for progressive or painful lesions (a skeletal related event as defined in the study) at the time of symptom development*(not upfront palliative radiation therapy) Receives: Drug: Standard of care systemic therapy |
| Prophylactic Radiation Therapy | Experimental | Patients randomized to Arm 2 of the study will undergo upfront prophylactic radiotherapy to ≤ 5 highest risk bone metastases followed by standard of care, as defined by:
1. Bulkiest sites of disease ≥ 2cm (can include paraspinal disease extension)
2. Disease in junctional spine (Occ-C2, C7-T1, T12-L1, L5-S1)
3. Disease with posterior element involvement (facet(s), interspinous)
4. Compression Deformity > 50% Receives: Radiation: Prophylactic Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who have skeletal-related events (SREs)
Number of skeletal related events (SREs), which will be defined as pathological fractures, spinal cord compression, or interventions (palliative RT, interventional procedures, or spine surgery)
Measured: 1 year
Secondary outcomes (6)
Number of skeletal-related event (SRE) hospitalizations
Number of hospitalizations attributed to skeletal-related events (SREs)
Measured: 1 year
Pain-related quality of life
Pain-related quality of life using the Brief Pain Inventory (BPI) form. The BPI is a 17-item patient self-rating scale assessing demographic data, use of medications, as well as the sensory and reactive components of pain. The scale is from 0-10, and there are breakpoints between scores of 4 and 5 and between 6 and 7, indicating that mild pain correlates with scores of 1-4, moderate pain with 5-6, and severe pain with scores of 7-10.
Measured: 3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE)
Health care utilities and quality of life
Health care utilities and quality of life using the EuroQol Group EQ-5D-5L form and FACT-G questionnaires. It has been developed to generate a generic cardinal index of health, thus giving it considerable potential for future use in economic evaluation. The EQ-5D-5L is a two-part, patient-completed questionnaire. The first part consists of 5 items covering 5 dimensions including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems. The second component is the visual analog scale, where the participant rates their own overall health on a scale of 0 (worst health) to 100 (best health).
Measured: 3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE)
Pain-free survival (PFS)
Pain-free survival (PFS) is defined as the time from study entry to until the start of opioid use or until death.
Measured: Until 1 year
Overall survival (OS)
Overall survival (OS) is defined as the time from study entry until death.
Measured: Until 1 year
Adverse event frequency and severity
Evaluate CTCAE v5 toxicity events in the upfront RT arm by tabulating all toxicities and summarizing the CTCAE v5 scores.
Measured: 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start29 Aug 2022
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Spine 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rupesh R Kotecha, MD, Principal investigator, Baptist Health Herbert Wertheim Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534321
- Sponsor's protocol ID
- 2021-KOT-002
- Acronym
- PROMISSeD
- Status last verified
- Oct 2026
- First submitted
- 6 Sep 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mundy GR. Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer. 2002 Aug;2(8):584-93. doi: 10.1038/nrc867.
PubMed 12154351Lutz ST, Jones J, Chow E. Role of radiation therapy in palliative care of the patient with cancer. J Clin Oncol. 2014 Sep 10;32(26):2913-9. doi: 10.1200/JCO.2014.55.1143. Epub 2014 Aug 11.
PubMed 25113773Lutz S, Balboni T, Jones J, Lo S, Petit J, Rich SE, Wong R, Hahn C. Palliative radiation therapy for bone metastases: Update of an ASTRO Evidence-Based Guideline. Pract Radiat Oncol. 2017 Jan-Feb;7(1):4-12. doi: 10.1016/j.prro.2016.08.001. Epub 2016 Aug 5.
PubMed 27663933Rades D, Segedin B, Conde-Moreno AJ, Garcia R, Perpar A, Metz M, Badakhshi H, Schreiber A, Nitsche M, Hipp P, Schulze W, Adamietz IA, Norkus D, Rudat V, Cacicedo J, Schild SE. Radiotherapy With 4 Gy x 5 Versus 3 Gy x 10 for Metastatic Epidural Spinal Cord Compression: Final Results of the SCORE-2 Trial (ARO 2009/01). J Clin Oncol. 2016 Feb 20;34(6):597-602. doi: 10.1200/JCO.2015.64.0862. Epub 2016 Jan 4.
PubMed 26729431Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, Moore M, Rydall A, Rodin G, Tannock I, Donner A, Lo C. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014 May 17;383(9930):1721-30. doi: 10.1016/S0140-6736(13)62416-2. Epub 2014 Feb 19.
PubMed 24559581Rothrock RJ, Reiner AS, Barzilai O, Kim NC, Ogilvie SQ, Lis E, Gulati A, Yamada Y, Bilsky MH, Laufer I. Responder Analysis of Pain Relief After Surgery for the Treatment of Spinal Metastatic Tumors. Neurosurgery. 2022 Oct 1;91(4):604-617. doi: 10.1227/neu.0000000000002083. Epub 2022 Jul 22.
PubMed 35856981Lipton A, Theriault RL, Hortobagyi GN, Simeone J, Knight RD, Mellars K, Reitsma DJ, Heffernan M, Seaman JJ. Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases: long term follow-up of two randomized, placebo-controlled trials. Cancer. 2000 Mar 1;88(5):1082-90. doi: 10.1002/(sici)1097-0142(20000301)88:53.0.co;2-z.
PubMed 10699899Saad F, Gleason DM, Murray R, Tchekmedyian S, Venner P, Lacombe L, Chin JL, Vinholes JJ, Goas JA, Zheng M; Zoledronic Acid Prostate Cancer Study Group. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J Natl Cancer Inst. 2004 Jun 2;96(11):879-82. doi: 10.1093/jnci/djh141.
PubMed 15173273Rosen LS, Gordon D, Tchekmedyian NS, Yanagihara R, Hirsh V, Krzakowski M, Pawlicki M, De Souza P, Zheng M, Urbanowitz G, Reitsma D, Seaman J. Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with nonsmall cell lung carcinoma and other solid tumors: a randomized, Phase III, double-blind, placebo-controlled trial. Cancer. 2004 Jun 15;100(12):2613-21. doi: 10.1002/cncr.20308.
PubMed 15197804Saad F, Lipton A. Zoledronic acid is effective in preventing and delaying skeletal events in patients with bone metastases secondary to genitourinary cancers. BJU Int. 2005 Nov;96(7):964-9. doi: 10.1111/j.1464-410X.2005.05740.x.
PubMed 16225510Duran I, Fink MG, Bahl A, Hoefeler H, Mahmood A, Luftner D, Ghazal H, Wei R, Chung KC, Hechmati G, Green J, Atchison C. Health resource utilisation associated with skeletal-related events in patients with bone metastases secondary to solid tumours: regional comparisons in an observational study. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12452. Epub 2016 Feb 10.
PubMed 26865392Luftner D, Lorusso V, Duran I, Hechmati G, Garzon-Rodriguez C, Ashcroft J, Bahl A, Ghelani P, Wei R, Thomas E, Hoefeler H. Health resource utilization associated with skeletal-related events in patients with advanced breast cancer: results from a prospective, multinational observational study. Springerplus. 2014 Jun 30;3:328. doi: 10.1186/2193-1801-3-328. eCollection 2014.
PubMed 25045611Stopeck A, Rader M, Henry D, Danese M, Halperin M, Cong Z, Qian Y, Dansey R, Chung K. Cost-effectiveness of denosumab vs zoledronic acid for prevention of skeletal-related events in patients with solid tumors and bone metastases in the United States. J Med Econ. 2012;15(4):712-23. doi: 10.3111/13696998.2012.675380. Epub 2012 Mar 27.
PubMed 22409231Degen JW, Gagnon GJ, Voyadzis JM, McRae DA, Lunsden M, Dieterich S, Molzahn I, Henderson FC. CyberKnife stereotactic radiosurgical treatment of spinal tumors for pain control and quality of life. J Neurosurg Spine. 2005 May;2(5):540-9. doi: 10.3171/spi.2005.2.5.0540.
PubMed 15945428Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983 Oct;17(2):197-210. doi: 10.1016/0304-3959(83)90143-4.
PubMed 6646795
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease (PROMISSeD Trial)
- ClinicalTrials.gov ID
- NCT05534321
- Acronym / sponsor ID
- PROMISSeD / 2021-KOT-002
- Conditions
- Spine Metastases
- Keywords
- Radiotherapy (RT), Palliative radiotherapy, High-risk asymptomatic spine metastases, Minimal asymptomatic spine metastases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 9 Sep 2022 (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.
Early palliative care has been shown to improve the quality of life and even survival for patients with metastatic cancer. More and more supportive oncology teams in cancer centers now advocate for early integration of radiation therapy (RT) in a patient's palliative management course. While multiple randomized studies have evaluated the efficacy of different RT regimens in the treatment of symptomatic bone lesions, few studies have examined the impact of early, upfront RT for asymptomatic or minimally symptomatic (non- opioid dependent) spine metastases and its efficacy in preventing skeletal-related events (SREs). Since the pathophysiology of spinal metastatic disease is distinct from other bony metastatic disease, the proposed trial seeks to understand whether it is beneficial to patients with minimally symptomatic disease to undergo upfront RT to reduce the risks of SREs and their sequelae, including hospitalizations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Systemic Therapy or Surveillance | Active comparator | Drug: Standard of care systemic therapyPatients randomized to arm 1 will undergo appropriate systemic therapy as determined by their oncology team. These patients will either continue the current therapy or be transitioned to a new standard of care therapy at the discretion of the treating oncologist. If randomized to arm 1, these patients may also undergo palliative radiation therapy for progressive or painful lesions (a skeletal related event as defined in the study) at the time of symptom development*(not upfront palliative radiation therapy) |
| Prophylactic Radiation Therapy | Experimental | Radiation: Prophylactic RadiotherapyPatients randomized to Arm 2 of the study will undergo upfront prophylactic radiotherapy to ≤ 5 highest risk bone metastases followed by standard of care, as defined by: 1. Bulkiest sites of disease ≥ 2cm (can include paraspinal disease extension) 2. Disease in junctional spine (Occ-C2, C7-T1, T12-L1, L5-S1) 3. Disease with posterior element involvement (facet(s), interspinous) 4. Compression Deformity > 50% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging.
- Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as:
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
- Age ≥ 18 years.
- Able to provide informed consent.
Key exclusion criteria (6 listed)
- Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
- Serious medical co-morbidities precluding RT.
- Pregnant or lactating women.
- Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture.
- Leptomeningeal disease.
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 RadiotherapyRadiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, three-dimensional conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT), and stereotactic radiosurgery/stereotactic body radiation therapy (SRS/SBRT) techniques may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards. | Radiation | Prophylactic Radiation Therapy |
| Standard of care systemic therapyStandard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists. | Drug | Standard of Care Systemic Therapy or Surveillance |
Primary outcome
Number of patients who have skeletal-related events (SREs)
Time frame: 1 year
Number of skeletal related events (SREs), which will be defined as pathological fractures, spinal cord compression, or interventions (palliative RT, interventional procedures, or spine surgery)
6 secondary outcomes
Number of skeletal-related event (SRE) hospitalizations
Time frame: 1 year
Pain-related quality of life
Time frame: 3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE)
Health care utilities and quality of life
Time frame: 3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE)
Pain-free survival (PFS)
Time frame: Until 1 year
Overall survival (OS)
Time frame: Until 1 year
Adverse event frequency and severity
Time frame: 3 months, 6 months, and 12 months
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 13 Oct 2026.
- Background: PubMed 12154351Mundy GR. Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer. 2002 Aug;2(8):584-93. doi: 10.1038/nrc867.
- Background: PubMed 25113773Lutz ST, Jones J, Chow E. Role of radiation therapy in palliative care of the patient with cancer. J Clin Oncol. 2014 Sep 10;32(26):2913-9. doi: 10.1200/JCO.2014.55.1143. Epub 2014 Aug 11.
- Background: PubMed 27663933Lutz S, Balboni T, Jones J, Lo S, Petit J, Rich SE, Wong R, Hahn C. Palliative radiation therapy for bone metastases: Update of an ASTRO Evidence-Based Guideline. Pract Radiat Oncol. 2017 Jan-Feb;7(1):4-12. doi: 10.1016/j.prro.2016.08.001. Epub 2016 Aug 5.
- Background: PubMed 26729431Rades D, Segedin B, Conde-Moreno AJ, Garcia R, Perpar A, Metz M, Badakhshi H, Schreiber A, Nitsche M, Hipp P, Schulze W, Adamietz IA, Norkus D, Rudat V, Cacicedo J, Schild SE. Radiotherapy With 4 Gy x 5 Versus 3 Gy x 10 for Metastatic Epidural Spinal Cord Compression: Final Results of the SCORE-2 Trial (ARO 2009/01). J Clin Oncol. 2016 Feb 20;34(6):597-602. doi: 10.1200/JCO.2015.64.0862. Epub 2016 Jan 4.
- Background: PubMed 24559581Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, Moore M, Rydall A, Rodin G, Tannock I, Donner A, Lo C. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014 May 17;383(9930):1721-30. doi: 10.1016/S0140-6736(13)62416-2. Epub 2014 Feb 19.
- Background: PubMed 35856981Rothrock RJ, Reiner AS, Barzilai O, Kim NC, Ogilvie SQ, Lis E, Gulati A, Yamada Y, Bilsky MH, Laufer I. Responder Analysis of Pain Relief After Surgery for the Treatment of Spinal Metastatic Tumors. Neurosurgery. 2022 Oct 1;91(4):604-617. doi: 10.1227/neu.0000000000002083. Epub 2022 Jul 22.
- Background: PubMed 10699899Lipton A, Theriault RL, Hortobagyi GN, Simeone J, Knight RD, Mellars K, Reitsma DJ, Heffernan M, Seaman JJ. Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases: long term follow-up of two randomized, placebo-controlled trials. Cancer. 2000 Mar 1;88(5):1082-90. doi: 10.1002/(sici)1097-0142(20000301)88:53.0.co;2-z.
- Background: PubMed 15173273Saad F, Gleason DM, Murray R, Tchekmedyian S, Venner P, Lacombe L, Chin JL, Vinholes JJ, Goas JA, Zheng M; Zoledronic Acid Prostate Cancer Study Group. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J Natl Cancer Inst. 2004 Jun 2;96(11):879-82. doi: 10.1093/jnci/djh141.
- Background: PubMed 15197804Rosen LS, Gordon D, Tchekmedyian NS, Yanagihara R, Hirsh V, Krzakowski M, Pawlicki M, De Souza P, Zheng M, Urbanowitz G, Reitsma D, Seaman J. Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with nonsmall cell lung carcinoma and other solid tumors: a randomized, Phase III, double-blind, placebo-controlled trial. Cancer. 2004 Jun 15;100(12):2613-21. doi: 10.1002/cncr.20308.
- Background: PubMed 16225510Saad F, Lipton A. Zoledronic acid is effective in preventing and delaying skeletal events in patients with bone metastases secondary to genitourinary cancers. BJU Int. 2005 Nov;96(7):964-9. doi: 10.1111/j.1464-410X.2005.05740.x.
- Background: PubMed 26865392Duran I, Fink MG, Bahl A, Hoefeler H, Mahmood A, Luftner D, Ghazal H, Wei R, Chung KC, Hechmati G, Green J, Atchison C. Health resource utilisation associated with skeletal-related events in patients with bone metastases secondary to solid tumours: regional comparisons in an observational study. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12452. Epub 2016 Feb 10.
- Background: PubMed 25045611Luftner D, Lorusso V, Duran I, Hechmati G, Garzon-Rodriguez C, Ashcroft J, Bahl A, Ghelani P, Wei R, Thomas E, Hoefeler H. Health resource utilization associated with skeletal-related events in patients with advanced breast cancer: results from a prospective, multinational observational study. Springerplus. 2014 Jun 30;3:328. doi: 10.1186/2193-1801-3-328. eCollection 2014.
- Baptist Health Herbert Wertheim Cancer InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Rupesh R Kotecha, MD principal investigator
Baptist Health Herbert Wertheim Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Prophylactic Radiotherapy in people with Spine Metastases, run by Baptist Health South Florida at 1 site in United States.
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 10 inclusion and 6 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 13 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Rupesh R Kotecha, MD ((786) 596-2000, rupeshk@baptisthealth.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who have skeletal-related events (SREs) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05534321, which also lists 22 linked publications.
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 13 Oct 2026.