Trial Outcomes & Findings for Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer (NCT NCT03361735)

Last Updated: 2026-04-09

Results Overview

Defined as time from the initiation of androgen deprivation therapy (ADT) for metastatic disease until PSA increase to \> pre-ADT level or PSA \> 10 (whichever is smaller) or radiographic or clinical progression or resumption of ADT by physician's choice.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

Assessed up to 5 years

Results posted on

2026-04-09

Participant Flow

25 patients were enrolled between August 2018 and July 2023, including 6 de novo and 19 oligoprogressive mCSPC patients. 1 patient did not receive any cycles of Ra-223 and thus was excluded from analysis.

Participant milestones

Participant milestones
Measure	De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection	Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection
Overall Study STARTED	6	18
Overall Study COMPLETED	6	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=6 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection	Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=18 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection	Total n=24 Participants Total of all reporting groups
Age, Continuous	66 years n=36 Participants	70 years n=78 Participants	68 years n=23 Participants
Sex: Female, Male Female	0 Participants n=36 Participants	0 Participants n=78 Participants	0 Participants n=23 Participants
Sex: Female, Male Male	6 Participants n=36 Participants	18 Participants n=78 Participants	24 Participants n=23 Participants
Race/Ethnicity, Customized African American	0 Participants n=36 Participants	1 Participants n=78 Participants	1 Participants n=23 Participants
Race/Ethnicity, Customized Asian	1 Participants n=36 Participants	3 Participants n=78 Participants	4 Participants n=23 Participants
Race/Ethnicity, Customized Hispanic/Latino	1 Participants n=36 Participants	3 Participants n=78 Participants	4 Participants n=23 Participants
Race/Ethnicity, Customized White	4 Participants n=36 Participants	10 Participants n=78 Participants	14 Participants n=23 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=36 Participants	1 Participants n=78 Participants	1 Participants n=23 Participants
Region of Enrollment United States	6 participants n=36 Participants	18 participants n=78 Participants	24 participants n=23 Participants

PRIMARY outcome

Timeframe: Assessed up to 5 years

Outcome measures

Outcome measures
Measure	De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=6 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection	Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=18 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection
Time to Treatment Failure	42.1 months Interval 2.5 to Upper limit can not be estimated due to insufficient number of participants with events.	17.0 months Interval 13.1 to 21.7

PRIMARY outcome

Timeframe: Up to 5 years

Response will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Complete Response (CR), Disappearance of all target lesions. Lymph node CR is when the lymph node has decreased to less than 10mm in the short axis; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; For non-target lesions, CR: Disappearance of all non-target lesions and PSA level \<0.04 (undetectable). Overall Response (OR) = CR + PR. Proportion of patients achieving CR or PR at course 8, day 1 (post 6 doses of radium Ra 223 dichloride) were reported.

Outcome measures

Outcome measures
Measure	De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=6 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection	Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=18 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection
Objective Response Rate	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From the initiation of ADT for metastatic disease until PSA progression or radiographic progression or death, assessed up to 5 years

Progression will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Progressive Disease (PD), At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started (including the baseline scan if that is the smallest), and at least a 5mm increase or the appearance of new lesions; For non-target lesions, PD: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PSA increase by ≥ 25 % over baseline and to at least PSA \>2 ng/mL.

Outcome measures

Outcome measures
Measure	De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=6 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection	Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=18 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection
Progression-free Survival	42.1 months Interval 2.5 to Upper limit can not be estimated due to insufficient number of participants with events.	17.8 months Interval 13.1 to 23.0

SECONDARY outcome

Timeframe: From date of initiation of protocol treatment to date of death from any cause, assessed up to 5 years

Outcome measures

Outcome measures
Measure	De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=6 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection	Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=18 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection
Overall Survival	NA months Interval 40.1 to Median OS and upper limit not reached due to the insufficient number of participants with events.	NA months Interval 47.2 to Median OS and upper limit not reached due to the insufficient number of participants with events.

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome measures
Measure	De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=6 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection	Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=18 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection
Complete Response (CR) Rate Defined as the Proportion of Patients Achieving CR	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From documented response to recurrent or progressive disease is first met, assessed up to 5 years

Population: No patient achieved a complete or partial response; therefore, the duration of response could not be calculated.

Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From documented CR to recurrent/ progressive disease, assessed up to 5 years

Population: No patient achieved a complete or partial response; therefore, the duration of response could not be calculated.

Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time to progression of bone specific disease over baseline, assessed up to 5 years

Progression will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria. Progression will be evaluated in this study using the modified Prostate Cancer Working Group 2 criteria. Per Prostate Cancer Working Group 2 criteria for target lesions: Progressive Disease (PD), At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started (including the baseline scan if that is the smallest), and at least a 5mm increase or the appearance of new lesions; For non-target lesions, PD: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. PSA increase by ≥ 25 % over baseline and to at least PSA \>2 ng/mL.

Outcome measures

Outcome measures
Measure	De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=6 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection	Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=18 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection
Bone Specific Progression-free Survival	34.3 months Interval 2.5 to Upper limit of bone specific progression-free survival not reached due to insufficient number of participants with events.	NA months Interval 13.1 to Median bone specific progression-free survival is not reached due to the insufficient number of participants with events; upper limit also not reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Time from start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, assessed up to 5 years

Population: Only the 23 patients who had a best response of stable disease were included in this analysis.

Response will be evaluated in this study using modified Prostate Cancer Working Group 2 criteria.

Outcome measures

Outcome measures
Measure	De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=5 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection	Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=18 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection
Duration of Stable Disease	49.9 months Interval 26.2 to Upper limit of duration of stable disease not reached due to insufficient number of participants with events.	17.8 months Interval 13.1 to 23.0

SECONDARY outcome

Timeframe: Up to 5 years

Toxicity will be graded. The highest AE grade per cycle will be reported in the electronic case report form (eCRF) from start of therapy until the end of treatment visit.

Outcome measures

Outcome measures
Measure	De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=6 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection	Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride) n=18 Participants Beginning 4 weeks (28 days) prior to radiation therapy, patients receive leuprolide acetate or goserelin acetate, for up to 32 weeks. Patients also undergo 3-5 fractions of SBRT every 40 hours over 7-21 days beginning on day 1 of course 1, and receive radium Ra 223 dichloride IV over 1 minute on day 1 of courses 2-7. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Leuprolide Acetate: Intramuscular or subcutaneous injection Goserelin Acetate: Subcutaneous injection Stereotactic Body Radiation Therapy: Undergo SBRT Radium Ra 223 Dichloride: Given IV Laboratory Biomarker Analysis: Correlative studies Degarelix: Subcutaneous injection
Number of Participants With Adverse Events (AE) Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0	6 Participants	18 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 5 years

The rate of normalization of the total alkaline phosphatase level (defined as a return to a value within the normal range) at the end of protocol therapy in patients with total alkaline phosphatase values above the upper limit of the normal range at baseline will be assessed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

Adverse Events

De Novo mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 1 deaths

Oligoprogressive mCSPC Patients. Treatment (Hormone Therapy, SBRT, Radium Ra 223 Dichloride)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Paul Frankel, Ph.D.

City of Hope

Phone: 6262185265

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place