Castration-Resistant Prostate CarcinomaNCT04693377
Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial
A study testing Cryosurgery, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy in people with Castration-Resistant Prostate Carcinoma and Metastatic Colorectal Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial compares cryoablation combined with stereotactic body radiation therapy to stereotactic body radiation therapy alone to see how well they work in treating patients with pain from cancer that has spread to the bones (bone metastases). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Castration-Resistant Prostate Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Bone
- What is being tested?
- Cryosurgery, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 1 Apr 2027
- Phase
- Interventional
- 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
- Patient must have a primary diagnosis of malignancy and radiographic evidence of bone metastases. Eligible tumor histologies include the following malignancies with low alpha/beta ratios: renal cell carcinoma, urothelial carcinomas, castration-resistant prostate cancer, sarcoma, thyroid carcinoma, colorectal carcinoma, and melanoma
- A target lesion the meets the following criteria:
- The target lesion must be amenable to both cryoablation and SBRT, as determined by the study principal investigators (PIs)
- The target lesion must be =< 7cm
- The pain due to the target lesion must be at least 4/10 based on the BPI pain scale
- Pain from the metastatic site must correlate with an identifiable tumor on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) imaging
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- Life expectancy >= 3 months
- Platelet count > 50,000/mm^3 within 6 weeks of screening
- International normalized ratio (INR) < 1.5 within 6 weeks of screening
- If taking antiplatelet or anticoagulation medication, it must be able to be discontinued 48 hours prior to the procedure or at the discretion of the PI (e.g., aspirin, ibuprofen, low molecular weight heparin [LMWH] preparations)
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) within 6 weeks of screening
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization. Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization
- All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Prior locoregional therapy to target lesion, including ablation of any modality, embolization, radiation, or surgery
- Patient may not be receiving any other investigational agents. Standard concurrent chemotherapy, immunotherapy, or targeted therapy will be allowed
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator
- Target lesions that involve the spinal column or calvarium
- Absolute neutrophil count < 1000 mm^3 within 6 weeks of screening
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- Active infection
- Presence of confirmed pathologic fracture at the target lesion not amenable to percutaneous stabilization
- Lesions that involve a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone. Lesions involving the hands and feet
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
M D Anderson Cancer Center
Houston, Texas, 77030
Rahul A. Sheth, MD, 713-745-0652
Rahul A. Sheth, MD
About this study
Official title: Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases
This trial compares cryoablation combined with stereotactic body radiation therapy to stereotactic body radiation therapy alone to see how well they work in treating patients with pain from cancer that has spread to the bones (bone metastases). Bone is a common site of metastasis in advanced cancer, and bone metastases often result in debilitating cancer-related pain. The current standard of care to treat painful bone metastases is radiation therapy alone. However, many patients do not get adequate pain relief from radiation therapy alone. Another type of therapy that may be used to provide pain relief from bone metastases is cryoablation. Cryoablation is a procedure in which special needles are inserted into the tumor site. These needles grow ice balls at their tips to freeze and kill cancer cells. The goal of this trial is to compare how well cryoablation in combination with radiation therapy works to radiation therapy alone when given to cancer patients to provide pain relief from bone metastases.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy of cryoablation in combination with stereotactic body radiation therapy (SBRT) or SBRT only for the treatment of painful bone metastases.
SECONDARY OBJECTIVES:
- To assess for narcotics utilization by daily morphine equivalent dose. II. To assess duration of pain response reported by International Pain Response Criteria.
III. To assess for local tumor control. IV. To assess for changes in patient quality of life with Brief Pain Inventory (BPI) score.
- To assess for adverse event rates. VI. To assess incidence and severity of adverse events/toxicity. VII. To assess technical success for cryoablation.
EXPLORATORY OBJECTIVE:
- To investigate the local microenvironmental changes following SBRT and cryoablation combined with SBRT to bone metastases.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo stereotactic body radiation therapy for 1 fraction.
ARM B: Patients undergo cryoablation. Within 10 days after cryoablation, patients undergo stereotactic body radiation therapy for 1 fraction.
After completion of study treatment, patients are followed up at 1, 2, 3, 4, 8, 12, 16, 20, and 24 weeks.
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Prostate Carcinoma
- Being tested
- Cryosurgery, Quality-of-Life Assessment, Stereotactic Body Radiation Therapy
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Melanoma, Prostatic Neoplasms, Carcinoma, Renal Cell, Sarcoma, Thyroid Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryosurgeryProcedure or surgery
Also called Ablation, Cryo, Cryoablation, cryosurgical ablation
Undergo cryoablation
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Stereotactic Body Radiation TherapyRadiation
Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Undergo stereotactic body radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A (SBRT) | Active comparator | Patients undergo stereotactic body radiation therapy for 1 fraction. Receives: Other: Quality-of-Life Assessment; Radiation: Stereotactic Body Radiation Therapy |
| Arm B (cryoablation, SBRT) | Experimental | Patients undergo cryoablation. Within 10 days after cryoablation, patients undergo stereotactic body radiation therapy for 1 fraction. Alternatively, patients may receive stereotactic body radiation therapy initially, followed by cryoablation." Receives: Procedure: Cryosurgery; Other: Quality-of-Life Assessment; Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain response
Defined as complete or partial response as reported by the International Pain Response Criteria at the site of the treated bone metastasis based on the BPI pain score and daily morphine equivalent (MEDD). Will be summarized separately for each treatment arm with associated 95% exact confidence intervals.
Measured: At 12 weeks post-treatment
Secondary outcomes (5)
Daily morphine equivalent (MEDD)
Measured: Baseline, assessed up to 24 weeks post-treatment
Duration of response
Will be assessed by performing area under the curve (AUC) analysis of Brief Pain Inventory (BPI) pain scores.
Measured: Up to 24 weeks post-treatment
Local control
Will be determined by imaging evidence of residual viable tumor. Standard of care cross-sectional imaging and bone scintigraphy will be performed at 3 month intervals.
Measured: Up to 24 weeks post-treatment
Rate and severity of adverse and serious related adverse events
Point estimates and two-sided 95% confidence intervals will be generated for procedural related adverse events.
Measured: Within 30 days of the last study treatment
Technical success for cryoablation
Will be determined by identifying on intra-procedural imaging when the leading edge of the ice successfully extends beyond the tumor margin by at least 5 mm.
Measured: Up to 24 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start16 Mar 2021
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Castration-Resistant Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rahul A Sheth, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693377
- Sponsor's protocol ID
- 2019-1234
- Other IDs
- NCI-2020-07368, 2019-1234
- Status last verified
- Apr 2026
- First submitted
- 13 Oct 2020
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Stringam J, Pal K, Niekamp A, Jiwani R, Paolucci I, Kuban JD, Metwalli Z, Huang S, Habibollahi P, Chen S, Yevich S, Patel M, Subudhi SK, Campbell M, Ghia A, Tatsui C, Sheth RA. Safety, Efficacy, and Adjacent-level Fracture Risk Following Vertebral Augmentation and Radiofrequency Ablation for the Treatment of Spine Metastases in Patients with Cancer. Radiol Imaging Cancer. 2025 May;7(3):e240122. doi: 10.1148/rycan.240122.
PubMed 40377420
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases
- ClinicalTrials.gov ID
- NCT04693377
- Acronym / sponsor ID
- 2019-1234
- Conditions
- Castration-Resistant Prostate Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Metastatic Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 5 Jan 2021 (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 trial compares cryoablation combined with stereotactic body radiation therapy to stereotactic body radiation therapy alone to see how well they work in treating patients with pain from cancer that has spread to the bones (bone metastases). Bone is a common site of metastasis in advanced cancer, and bone metastases often result in debilitating cancer-related pain. The current standard of care to treat painful bone metastases is radiation therapy alone. However, many patients do not get adequate pain relief from radiation therapy alone. Another type of therapy that may be used to provide pain relief from bone metastases is cryoablation. Cryoablation is a procedure in which special needles are inserted into the tumor site. These needles grow ice balls at their tips to freeze and kill cancer cells. The goal of this trial is to compare how well cryoablation in combination with radiation therapy works to radiation therapy alone when given to cancer patients to provide pain relief from bone metastases.
Detailed description
PRIMARY OBJECTIVE:
- To determine the efficacy of cryoablation in combination with stereotactic body radiation therapy (SBRT) or SBRT only for the treatment of painful bone metastases.
SECONDARY OBJECTIVES:
- To assess for narcotics utilization by daily morphine equivalent dose. II. To assess duration of pain response reported by International Pain Response Criteria.
III. To assess for local tumor control. IV. To assess for changes in patient quality of life with Brief Pain Inventory (BPI) score.
- To assess for adverse event rates. VI. To assess incidence and severity of adverse events/toxicity. VII. To assess technical success for cryoablation.
EXPLORATORY OBJECTIVE:
- To investigate the local microenvironmental changes following SBRT and cryoablation combined with SBRT to bone metastases.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo stereotactic body radiation therapy for 1 fraction.
ARM B: Patients undergo cryoablation. Within 10 days after cryoablation, patients undergo stereotactic body radiation therapy for 1 fraction.
After completion of study treatment, patients are followed up at 1, 2, 3, 4, 8, 12, 16, 20, and 24 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (SBRT) | Active comparator | Other: Quality-of-Life Assessment, Radiation: Stereotactic Body Radiation TherapyPatients undergo stereotactic body radiation therapy for 1 fraction. |
| Arm B (cryoablation, SBRT) | Experimental | Procedure: Cryosurgery, Other: Quality-of-Life Assessment, Radiation: Stereotactic Body Radiation TherapyPatients undergo cryoablation. Within 10 days after cryoablation, patients undergo stereotactic body radiation therapy for 1 fraction. Alternatively, patients may receive stereotactic body radiation therapy initially, followed by cryoablation." |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient must have a primary diagnosis of malignancy and radiographic evidence of bone metastases. Eligible tumor histologies include the following malignancies with low alpha/beta ratios: renal cell carcinoma, urothelial carcinomas, castration-resistant prostate cancer, sarcoma, thyroid carcinoma, colorectal carcinoma, and melanoma
- A target lesion the meets the following criteria:
- Life expectancy >= 3 months
- Platelet count > 50,000/mm^3 within 6 weeks of screening
- International normalized ratio (INR) < 1.5 within 6 weeks of screening
Key exclusion criteria (9 listed)
- Prior locoregional therapy to target lesion, including ablation of any modality, embolization, radiation, or surgery
- Patient may not be receiving any other investigational agents. Standard concurrent chemotherapy, immunotherapy, or targeted therapy will be allowed
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator
- Target lesions that involve the spinal column or calvarium
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 |
|---|---|---|
| CryosurgeryAlso: Ablation, Cryo, Cryoablation, cryosurgical ablationUndergo cryoablation | Procedure or surgery | Arm B (cryoablation, SBRT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm A (SBRT), Arm B (cryoablation, SBRT) |
| Stereotactic Body Radiation TherapyAlso: SABR, SBRT, Stereotactic Ablative Body Radiation TherapyUndergo stereotactic body radiation therapy | Radiation | Arm A (SBRT), Arm B (cryoablation, SBRT) |
Primary outcome
Pain response
Time frame: At 12 weeks post-treatment
Defined as complete or partial response as reported by the International Pain Response Criteria at the site of the treated bone metastasis based on the BPI pain score and daily morphine equivalent (MEDD). Will be summarized separately for each treatment arm with associated 95% exact confidence intervals.
5 secondary outcomes
Daily morphine equivalent (MEDD)
Time frame: Baseline, assessed up to 24 weeks post-treatment
Duration of response
Time frame: Up to 24 weeks post-treatment
Local control
Time frame: Up to 24 weeks post-treatment
Rate and severity of adverse and serious related adverse events
Time frame: Within 30 days of the last study treatment
Technical success for cryoablation
Time frame: Up to 24 weeks post-treatment
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 15 Apr 2026.
- Derived from this study: PubMed 40377420Stringam J, Pal K, Niekamp A, Jiwani R, Paolucci I, Kuban JD, Metwalli Z, Huang S, Habibollahi P, Chen S, Yevich S, Patel M, Subudhi SK, Campbell M, Ghia A, Tatsui C, Sheth RA. Safety, Efficacy, and Adjacent-level Fracture Risk Following Vertebral Augmentation and Radiofrequency Ablation for the Treatment of Spine Metastases in Patients with Cancer. Radiol Imaging Cancer. 2025 May;7(3):e240122. doi: 10.1148/rycan.240122.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Rahul A Sheth, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryosurgery, Quality-of-Life Assessment and Stereotactic Body Radiation Therapy in people with Castration-Resistant Prostate Carcinoma and Metastatic Colorectal Carcinoma, run by M.D. Anderson Cancer Center 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 14 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 15 Apr 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.
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 Rahul A. Sheth, MD (713-745-0652, rasheth@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain response (time frame: At 12 weeks post-treatment). 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 NCT04693377, which also lists 1 linked publication.
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 15 Apr 2026.