Trial Outcomes & Findings for Treatment of Cancer-Related Bone Pain by Using Bone-Targeted Radiation-Based Therapy (Sn-117m-DTPA) in Patients With Prostate Cancer That Has Spread to Bones (NCT NCT04616547)

Last Updated: 2025-10-03

Results Overview

Defined as achieving pain index =\< 3 within a 12-week period, maintaining that pain index =\< 3 over a 16-week time period. Will also be summarized by the point estimation of the overall response rate (ORR) with the corresponding 95% confidence intervals. Patients who received any amount of study drug will be included in the denominator for the calculation of ORR.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Baseline to 16 weeks

Results posted on

2025-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Tin Sn 117m DTPA Patients receive tin Sn 117m DTPA IV over 5-10 minutes on day 1. Treatment repeats every 8 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive tin Sn 117m DTPA for an additional 2 cycles if pain recurs within 6 months after a 16-week pain observation period and no disease progression on bone scans, or evidence of clinical progression. Questionnaire Administration: Ancillary studies Tin Sn 117m Pentetate: Given IV
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Cancer-Related Bone Pain by Using Bone-Targeted Radiation-Based Therapy (Sn-117m-DTPA) in Patients With Prostate Cancer That Has Spread to Bones

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tin Sn 117m DTPA n=1 Participants Patients receive tin Sn 117m DTPA IV over 5-10 minutes on day 1. Treatment repeats every 8 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive tin Sn 117m DTPA for an additional 2 cycles if pain recurs within 6 months after a 16-week pain observation period and no disease progression on bone scans, or evidence of clinical progression. Questionnaire Administration: Ancillary studies Tin Sn 117m Pentetate: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 16 weeks

Population: Data not collected and analyzed due to low enrollment to the study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months post-therapy

Population: Data not collected and analyzed due to low enrollment to the study

Safety and toxicity will be assessed through the frequency and percent of AEs, serious adverse events, and adverse events of special interests. Toxicity will be assessed using Common Terminology Criteria for Adverse Events. Will be assessed by patient reported outcomes (PROs) and AEs (PRO-Common Terminology Criteria for Adverse Events).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 4 weeks after the first Sn-117m-DTPA administration

Population: Data not collected due to low enrollment to the study

Gamma camera dosimetry will be used to evaluate whole-body distribution of Sn-117m-DTPA. Pearson's correlation coefficient method will be used to assess the correlation between the baseline technetium-99 bone scintigraphy measurement and the Sn-117m-DTPA uptake. If the observed data distribution is not appropriate to calculate the Pearson's correlation, post hoc analysis will be conducted using non-parametric methods or other methods suitable to the observed data distribution. The gamma dosimetry scan measurements will be reported descriptively as the average and standard deviation of dosimetry scan measurements and plotted over time and grouped by organ systems.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months after the first dose of tin Sn 117m DTPA

Population: Data not collected and analyzed due to low enrollment to the study

A Fisher's exact 95% confidence interval will be calculated for the overall response rate. The denominator will include all patients who received at least one dose of study treatment and do not have major protocol deviations. Patients who do not have observed clinical response will be counted as negative responses.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Population: Data not collected and analyzed due to low enrollment to the study

The time from study enrollment to the first use of external-beam radiation therapy to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention will be evaluated. Will be analyzed using the Kaplan-Meier method. Estimation and confidence intervals for the median time to first symptomatic skeletal event will be provided.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 12 weeks from first dose of Sn-117m-DTPA

Population: Data not collected and analyzed due to low enrollment to the study

The rate of achievement of pain index =\< 3 within 12 weeks from the first Sn-117m-DTPA will be evaluated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from the achievement of pain response (pain index =< 3) to the recurrence of pain (pain index >= 4), assessed up to 16 weeks

Population: Data not collected and analyzed due to low enrollment to the study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 weeks

Population: Data not collected and analyzed due to low enrollment to the study

Will be determined for the following benchmarks: \>= 30% reduction of the blood level, compared to the baseline value; \>= 50% reduction of the blood level, compared to the baseline value; confirmed PSA response: \>=50% reduction of the blood level, compared to the baseline value, and confirmed by a second PSA value approximately 4 or more weeks later.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 28 weeks

Population: Data not collected and analyzed due to low enrollment to the study

Will be determined for the following benchmarks: \>= 50% reduction of the blood level, compared to the baseline value; confirmed ALP response: \>= 50% reduction of the blood level, compared to the baseline value, and confirmed by a second ALP value approximately 4 or more weeks later.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time of study enrollment until disease progression, assessed up to 12 months

Population: Data not collected and analyzed due to low enrollment to the study

Defined as symptomatic progression (increasing pain from a metastatic lesion); progression of bone lesions assessed per Prostate Cancer Working Group 3 criteria; or progression of soft-tissue lesions assessed per Response Evaluation Criteria in Solid Tumors version 1.1 criteria. PSA progression without progression on bone lesions nor symptomatic is not considered as clinical progression. Will be summarized by Kaplan-Meier methods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time of the first study treatment until the date of death, assessed up to 12 months

Population: Data not collected and analyzed due to low enrollment to the study

Will be summarized by Kaplan-Meier methods.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 12 months

Population: Data not collected and analyzed due to low enrollment to the study

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to after completion of treatment

Population: Data not collected and analyzed due to low enrollment to the study

Will be summarized using descriptive statistics.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 12 months

Population: Data not collected and analyzed due to low enrollment to the study

Will be summarized using descriptive statistics.

Outcome measures

Outcome data not reported

Adverse Events

Tin Sn 117m DTPA

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Tin Sn 117m DTPA n=1 participants at risk Patients receive tin Sn 117m DTPA IV over 5-10 minutes on day 1. Treatment repeats every 8 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive tin Sn 117m DTPA for an additional 2 cycles if pain recurs within 6 months after a 16-week pain observation period and no disease progression on bone scans, or evidence of clinical progression. Questionnaire Administration: Ancillary studies Tin Sn 117m Pentetate: Given IV
Blood and lymphatic system disorders Anemia	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Infections and infestations Sepsis	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Skin and subcutaneous tissue disorders Skin Infection	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Metabolism and nutrition disorders Anorexia	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Respiratory, thoracic and mediastinal disorders Aspiration	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.

Other adverse events

Other adverse events
Measure	Tin Sn 117m DTPA n=1 participants at risk Patients receive tin Sn 117m DTPA IV over 5-10 minutes on day 1. Treatment repeats every 8 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive tin Sn 117m DTPA for an additional 2 cycles if pain recurs within 6 months after a 16-week pain observation period and no disease progression on bone scans, or evidence of clinical progression. Questionnaire Administration: Ancillary studies Tin Sn 117m Pentetate: Given IV
Blood and lymphatic system disorders Anemia	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Metabolism and nutrition disorders Anorexia	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Respiratory, thoracic and mediastinal disorders Aspiration	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Gastrointestinal disorders Diarrhea	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Nervous system disorders Dysphasia	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Ear and labyrinth disorders Ear and Labyrinth	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
General disorders Edema limbs	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Metabolism and nutrition disorders Hypocalcemia	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Metabolism and nutrition disorders Hypoglycemia	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Metabolism and nutrition disorders Hypokalemia	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Metabolism and nutrition disorders Hypomagnesemia	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Metabolism and nutrition disorders Hypophosphatemia	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Vascular disorders Hypotension	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Injury, poisoning and procedural complications Injection site reaction	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Investigations Lymphocyte count increased	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Investigations Neutrophil count decreased	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Investigations Platelet count decreased	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Infections and infestations Sepsis	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Cardiac disorders Sinus tachycardia	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Infections and infestations Skin infection	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Gastrointestinal disorders Vomiting	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Investigations Weight loss	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.
Investigations White blood cell decreased	100.0% 1/1 • Number of events 1 • The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used for grading patients adverse events. Adverse events were collected and monitored from the start of the study until study completion up to an average of 6 months.

Additional Information

Dr. Zin Myint

Markey Cancer Center

Phone: 866-340-4488

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place