Trial Outcomes & Findings for RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers (NCT NCT04037358)

Last Updated: 2025-12-19

Results Overview

Time to progression in men who have oligometastatic prostate cancer after therapy. Progression is defined by PCWG2 criteria as follows: \>=25% increase in PSA from nadir (and by \>=2ng/mL), and/or clinical/radiographic progression (clinical progression = symptomatic progression, worsening of disease-related symptoms or new cancer-related complications; radiographic progression on CT scan defined by RECIST 1.1 criteria: \>=20% enlargement in sum diameter of soft-tissue target lesions; or on bone scan \>=1 new bone lesions), initiation of ADT or death due to any cause, whichever occurs first.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

64 participants

Primary outcome timeframe

Up to 24 months

Results posted on

2025-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Radium-223 and SABR First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions
Overall Study STARTED	31	33
Overall Study COMPLETED	30	33
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Radium-223 and SABR First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions
Overall Study Patient withdrew before intervention	1	0

Baseline Characteristics

RAdium-223 and SABR Versus SABR for Oligometastatic Prostate Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radium-223 and SABR n=30 Participants First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR n=33 Participants SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	Total n=63 Participants Total of all reporting groups
Age, Continuous	66 years n=8 Participants	69 years n=6 Participants	68 years n=6 Participants
Sex: Female, Male Female	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Sex: Female, Male Male	30 Participants n=8 Participants	33 Participants n=6 Participants	63 Participants n=6 Participants
Race/Ethnicity, Customized Caucasian	27 Participants n=8 Participants	29 Participants n=6 Participants	56 Participants n=6 Participants
Race/Ethnicity, Customized African American	1 Participants n=8 Participants	3 Participants n=6 Participants	4 Participants n=6 Participants
Race/Ethnicity, Customized Asian	1 Participants n=8 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants
Race/Ethnicity, Customized Other	1 Participants n=8 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized Hispanic/Latino	2 Participants n=8 Participants	2 Participants n=6 Participants	4 Participants n=6 Participants
Race/Ethnicity, Customized Not Hispanic/Latino	28 Participants n=8 Participants	31 Participants n=6 Participants	59 Participants n=6 Participants
Region of Enrollment United States	25 Participants n=8 Participants	28 Participants n=6 Participants	53 Participants n=6 Participants
Region of Enrollment Canada	5 Participants n=8 Participants	5 Participants n=6 Participants	10 Participants n=6 Participants
International Society of Urological Pathology (ISUP) Group Grade ISUP Group Grade 1-3	17 Participants n=8 Participants	12 Participants n=6 Participants	29 Participants n=6 Participants
Initial Lesion Bone and Lymph node	9 Participants n=8 Participants	5 Participants n=6 Participants	14 Participants n=6 Participants
International Society of Urological Pathology (ISUP) Group Grade ISUP Group Grade 4-5	13 Participants n=8 Participants	21 Participants n=6 Participants	34 Participants n=6 Participants
Initial Management/Treatment Radiation	5 Participants n=8 Participants	7 Participants n=6 Participants	12 Participants n=6 Participants
Initial Management/Treatment Surgery	25 Participants n=8 Participants	26 Participants n=6 Participants	51 Participants n=6 Participants
Previous Hormone Therapy No	9 Participants n=8 Participants	11 Participants n=6 Participants	20 Participants n=6 Participants
Previous Hormone Therapy Yes	21 Participants n=8 Participants	22 Participants n=6 Participants	43 Participants n=6 Participants
Baseline PSA, ng/mL	6.20 ng/mL STANDARD_DEVIATION 8.24 • n=8 Participants	5.08 ng/mL STANDARD_DEVIATION 5.88 • n=6 Participants	5.61 ng/mL STANDARD_DEVIATION 7.06 • n=6 Participants
Initial Imaging Type Conventional Only	6 Participants n=8 Participants	3 Participants n=6 Participants	9 Participants n=6 Participants
Initial Imaging Type Conventional and PSMA-PET	9 Participants n=8 Participants	8 Participants n=6 Participants	17 Participants n=6 Participants
Initial Imaging Type Conventional and non-PSMA-PET	8 Participants n=8 Participants	9 Participants n=6 Participants	17 Participants n=6 Participants
Initial Imaging Type PSMA -PET Only	5 Participants n=8 Participants	9 Participants n=6 Participants	14 Participants n=6 Participants
Initial Imaging Type Non-PSMA-PET Only	2 Participants n=8 Participants	4 Participants n=6 Participants	6 Participants n=6 Participants
Initial Lesion Bone Only	21 Participants n=8 Participants	28 Participants n=6 Participants	49 Participants n=6 Participants
Total Lesion Number 1 Lesion	14 Participants n=8 Participants	20 Participants n=6 Participants	34 Participants n=6 Participants
Total Lesion Number 2 Lesions	7 Participants n=8 Participants	10 Participants n=6 Participants	17 Participants n=6 Participants
Total Lesion Number 3 Lesions	8 Participants n=8 Participants	2 Participants n=6 Participants	10 Participants n=6 Participants
Total Lesion Number 4 Lesions	0 Participants n=8 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants
Total Lesion Number 5 Lesions	1 Participants n=8 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants
Bone Lesions Number 1	20 Participants n=8 Participants	24 Participants n=6 Participants	44 Participants n=6 Participants
Bone Lesions Number 2	6 Participants n=8 Participants	9 Participants n=6 Participants	15 Participants n=6 Participants
Bone Lesions Number 3	4 Participants n=8 Participants	0 Participants n=6 Participants	4 Participants n=6 Participants
Bone Lesions Type No lesion outside pelvis/vertebra	19 Participants n=8 Participants	18 Participants n=6 Participants	37 Participants n=6 Participants
Bone Lesions Type Lesions outside pelvis/vertebra	11 Participants n=8 Participants	15 Participants n=6 Participants	26 Participants n=6 Participants
Extra-pelvic lymph nodes No	28 Participants n=8 Participants	31 Participants n=6 Participants	59 Participants n=6 Participants
Extra-pelvic lymph nodes Yes	2 Participants n=8 Participants	2 Participants n=6 Participants	4 Participants n=6 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Outcome measures

Outcome measures
Measure	Radium-223 and SABR n=30 Participants First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR n=33 Participants SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions
Progression-free Survival	10.5 Months Interval 7.3 to 12.4	11.8 Months Interval 6.67 to 21.2

SECONDARY outcome

Timeframe: Up to 24 months

Adverse events grade 3 or higher (defined by CTCAE v4.0) measured as treatment related events in either SABR or SABR and Radium-223 arms.

Outcome measures

Outcome measures
Measure	Radium-223 and SABR n=30 Participants First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR n=33 Participants SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions
Toxicity as Assessed by Number of Participants Who Experience Adverse Events Grade 3 or Greater (CTCAE v4.0) Insomnia	0 Participants	1 Participants
Toxicity as Assessed by Number of Participants Who Experience Adverse Events Grade 3 or Greater (CTCAE v4.0) Musculoskeletal Pain	1 Participants	0 Participants
Toxicity as Assessed by Number of Participants Who Experience Adverse Events Grade 3 or Greater (CTCAE v4.0) Grade 3 or higher Adverse Events	5 Participants	3 Participants
Toxicity as Assessed by Number of Participants Who Experience Adverse Events Grade 3 or Greater (CTCAE v4.0) Fatigue	0 Participants	1 Participants
Toxicity as Assessed by Number of Participants Who Experience Adverse Events Grade 3 or Greater (CTCAE v4.0) Lymphocyte Count Decrease	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: One patient in the SABR arm never received imaging (data not collected) afterward due to loss of follow up/died for other reasons, so that patient will be censored out or excluded.

Percentage of participants achieving local control at 12 months

Outcome measures

Outcome measures
Measure	Radium-223 and SABR n=30 Participants First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR n=32 Participants SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions
Rate of Local Control at 12 Months	0.794 percentage of participants Interval 0.628 to 1.0	0.908 percentage of participants Interval 0.793 to 1.0

SECONDARY outcome

Timeframe: 12 months

Population: There were no locoregional progression events at the site of SBRT during the time patients were on study.

Time from starting treatment until local and/or regional relapse is documented

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Time from starting treatment until distant relapse is documented

Outcome measures

Outcome measures
Measure	Radium-223 and SABR n=30 Participants First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR n=33 Participants SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions
Time to Distant Progression	11.9 Months Interval 8.6 to 15.1	12.1 Months Interval 9.1 to Upper 95% confidence interval not able to be estimated. Not estimable as there were too few events at later time points.

SECONDARY outcome

Timeframe: Up to 24 months

Time from treatment start to the time of a newly documented tumor metastasis by CT and/or bone scan. Subjects who do not progress will be censored at the time of the last contact.

Outcome measures

Outcome measures
Measure	Radium-223 and SABR n=30 Participants First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR n=33 Participants SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions
Metastasis-Free Survival	12.3 Months Interval 11.9 to Upper 95% confidence interval not able to be estimated. NA explanation is not estimable as there were too few events at later time points.	19.4 Months Interval 8.22 to Upper 95% confidence interval not able to be estimated. NA explanation is not estimable as there were too few events at later time points.

SECONDARY outcome

Timeframe: Up to 24 months

Time from randomization until initiation of androgen-deprivation therapy (ADT). ADT Free Survival (ADT-FS) is defined as the time from starting treatment to the time of initiation of palliative ADT.

Outcome measures

Outcome measures
Measure	Radium-223 and SABR n=30 Participants First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR n=33 Participants SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions
Androgen-deprivation Therapy (ADT)-Free Survival	16.2 Months Interval 12.3 to Upper 95% confidence interval not able to be estimated. NA explanation is not estimable as there were too few events at later time points. Standard nomenclature.	19.2 Months Interval 12.0 to Upper 95% confidence interval not able to be estimated. NA explanation is not estimable as there were too few events at later time points.

SECONDARY outcome

Timeframe: Baseline, Day 360

Population: Participants with missing data, and further 2 participants were not assessed due to disease progression for SBRT group and SBRT+Ra223 group, respectively.

The brief pain inventory assesses the severity of pain, location of pain, amount of pain over the last 24 hours, and impact of pain on daily functions. Scores for the 4 pain severity items and 7 pain interference items range from 0-10, where 10 is the worst pain or pain that completely interferes with described activity and 0 is the least pain or does not interfere with described activity. The mean of these scores is used to measure pain severity and pain interference.

Outcome measures

Outcome measures
Measure	Radium-223 and SABR n=28 Participants First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR n=30 Participants SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions
Quality of Life as Assessed by Pain Severity and Pain Interference Score With Imputations Using the Brief Pain Inventory Baseline BPI Score	0.31 score on a scale Interval 0.06 to 0.56	0.39 score on a scale Interval 0.01 to 0.77
Quality of Life as Assessed by Pain Severity and Pain Interference Score With Imputations Using the Brief Pain Inventory Day 360 BPI Score	0.56 score on a scale Interval 0.06 to 1.05	0.27 score on a scale Interval -0.2 to 0.73

SECONDARY outcome

Timeframe: Baseline, Day 360

Population: Participants with missing data, and further 2 participants were not assessed due to disease progression for SBRT group and SBRT+Ra223 group, respectively.

Outcome measures

Outcome measures
Measure	Radium-223 and SABR n=20 Participants First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR n=17 Participants SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions
Change in Quality of Life as Assessed by Pain Severity and Pain Interference With Imputations Using the Brief Pain Inventory	0.34 score on a scale Interval -0.07 to 0.74	-0.01 score on a scale Interval -0.13 to 0.11

SECONDARY outcome

Timeframe: 12 months

Time to New Metastasis (TNM) is defined as the time from starting treatment to the time of a new documented tumor metastasis by CT and/or bone scan. Subjects who do not progress will be censored at the time of the last contact.

Outcome measures

Outcome measures
Measure	Radium-223 and SABR n=30 Participants First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR n=33 Participants SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions
Time to New Metastatsis	11.9 Months Interval 8.6 to 15.1	12.0 Months Interval 8.2 to NA Explanation: Upper 95% confidence interval not able to be estimated. Not estimable as there were too few events at later time points.

SECONDARY outcome

Timeframe: 12 Months

Response will be defined as evidence of CR, PR, or stable disease. The duration of response will be measured from the start of treatment until the criteria for progression are met

Outcome measures

Outcome measures
Measure	Radium-223 and SABR n=30 Participants First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR n=33 Participants SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions
Duration of Response	10.5 Months Interval 7.3 to 12.4	11.8 Months Interval 6.7 to 21.2

Adverse Events

Radium-223 and SABR

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

SABR

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Ana P. Kiess

Johns Hopkins University School of Medicine

Phone: 443-287-7528

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Radium-223 and SABR n=31 participants at risk First radium-223 infusion will be within two weeks of SABR Radium-223: Radium-223 plus SABR will be within two weeks. stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions	SABR n=33 participants at risk SABR(1-5 fractions) will be administered for all men stereotactic ablative radiotherapy (SABR): SABR 1-5 fractions
Injury, poisoning and procedural complications Fracture	0.00% 0/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	3.0% 1/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Psychiatric disorders Insomnia	0.00% 0/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	6.1% 2/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Investigations Lymphocute cound decreased	74.2% 23/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	27.3% 9/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	16.1% 5/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	21.2% 7/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Gastrointestinal disorders Nausea	16.1% 5/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	3.0% 1/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	3.0% 1/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Renal and urinary disorders Urinary frequency	3.2% 1/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	6.1% 2/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Renal and urinary disorders Urinary incontinence	3.2% 1/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	3.0% 1/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Investigations Weight loss	3.2% 1/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	6.1% 2/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Psychiatric disorders Anxiety	6.5% 2/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	0.00% 0/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Injury, poisoning and procedural complications Bruising	3.2% 1/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	0.00% 0/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Metabolism and nutrition disorders Anorexia	9.7% 3/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	3.0% 1/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Metabolism and nutrition disorders Dehydration	3.2% 1/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	0.00% 0/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Nervous system disorders Dysgeusia	3.2% 1/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	0.00% 0/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Reproductive system and breast disorders Erectile Dysfunction	3.2% 1/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	0.00% 0/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	3.2% 1/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	0.00% 0/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Gastrointestinal disorders Hemorrhoids	3.2% 1/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	0.00% 0/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Metabolism and nutrition disorders Hyperkalemia	3.2% 1/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	0.00% 0/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Gastrointestinal disorders Diarrhea	25.8% 8/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	6.1% 2/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Injury, poisoning and procedural complications Compression Fracture	3.2% 1/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	0.00% 0/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Investigations Neutrophl count decreased	12.9% 4/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	0.00% 0/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Investigations Platelet count decreased	29.0% 9/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	0.00% 0/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Renal and urinary disorders Urinary Urgency	3.2% 1/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	0.00% 0/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
General disorders Any Adverse Event	87.1% 27/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	63.6% 21/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Gastrointestinal disorders Abdominal Pain	0.00% 0/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	3.0% 1/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Blood and lymphatic system disorders Anemia	51.6% 16/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	18.2% 6/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Gastrointestinal disorders Bloating	0.00% 0/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	3.0% 1/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Gastrointestinal disorders Anal Hemorrhage	0.00% 0/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	3.0% 1/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Gastrointestinal disorders Constipation	6.5% 2/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	12.1% 4/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
Gastrointestinal disorders Esophagitis	0.00% 0/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	3.0% 1/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.
General disorders Fatigue	41.9% 13/31 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.	21.2% 7/33 • From the time of enrollment to 1 year or until progression of disease (up to 2 years) CTCAE (4.0) Grade 3 or higher adverse events.