Trial Outcomes & Findings for High-Dose Stereotactic Radiation for Prostate Cancer (NCT NCT01664130)

NCT ID: NCT01664130

Last Updated: 2020-05-21

Results Overview

Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 35 participants
• Primary outcome timeframe: 1.5 months
• Results posted on: 2020-05-21

Participant Flow

Subjects were recruited from regional hospitals from July 2012 thru Jan 2015.

Participant milestones

Measure	Treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Overall Study STARTED	35
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Overall Study competing secondary disease	2

Baseline Characteristics

High-Dose Stereotactic Radiation for Prostate Cancer

Baseline characteristics by cohort

Measure	Treatment (SBRT) n=35 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Age, Customized 50-59 yrs	6 Participants n=5 Participants
Age, Customized 60-69 yrs	12 Participants n=5 Participants
Age, Customized 70-79 yrs	15 Participants n=5 Participants
Age, Customized 80-89 yrs	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 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	10 Participants n=5 Participants
Race (NIH/OMB) White	25 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	35 participants n=5 Participants

PRIMARY outcome

Timeframe: 1.5 months

Population: All patients that received treatment

Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

Outcome measures

Measure	Treatment (SBRT) n=35 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	1 Participants	—

PRIMARY outcome

Timeframe: 4 months

Population: Per protocol

Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

Outcome measures

Measure	Treatment (SBRT) n=35 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	0 Participants	—

PRIMARY outcome

Timeframe: 8 months

Population: Per protocol

Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

Outcome measures

Measure	Treatment (SBRT) n=35 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	0 Participants	—

PRIMARY outcome

Timeframe: 12 months

Population: All patients that received treatment

Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0

Outcome measures

Measure	Treatment (SBRT) n=35 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0	0 Participants	—

SECONDARY outcome

Timeframe: Baseline and 1.5 months

Population: Participants that were able to complete the questionnaire at specific time point.

Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.

Outcome measures

Measure	Treatment (SBRT) n=31 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) n=32 Participants After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Quality of Life as Assessed by EPIC Scores Urinary Incontenence Domain	83.2 score on a scale Standard Deviation 16.5	84.0 score on a scale Standard Deviation 18.7
Quality of Life as Assessed by EPIC Scores Bowel Domain	90.5 score on a scale Standard Deviation 12.4	83.7 score on a scale Standard Deviation 22.7
Quality of Life as Assessed by EPIC Scores Sexual Function Domain	46.4 score on a scale Standard Deviation 30.4	36.8 score on a scale Standard Deviation 28.3
Quality of Life as Assessed by EPIC Scores Hormonal Domain	80.6 score on a scale Standard Deviation 19.4	76.6 score on a scale Standard Deviation 20.7

SECONDARY outcome

Timeframe: Baseline and 4 months

Population: Participants that were able to complete the questionnaire at specific time point.

Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.

Outcome measures

Measure	Treatment (SBRT) n=32 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) n=33 Participants After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Quality of Life as Assessed by EPIC Scores Urinary Incontenence Domain	83.2 score on a scale Standard Deviation 16.5	85.0 score on a scale Standard Deviation 16.3
Quality of Life as Assessed by EPIC Scores Bowel Domain	90.5 score on a scale Standard Deviation 12.4	85.6 score on a scale Standard Deviation 21.1
Quality of Life as Assessed by EPIC Scores Sexual Function Domain	46.4 score on a scale Standard Deviation 30.4	33.6 score on a scale Standard Deviation 31.1
Quality of Life as Assessed by EPIC Scores Hormonal Domain	80.6 score on a scale Standard Deviation 19.4	79.4 score on a scale Standard Deviation 22.6

SECONDARY outcome

Timeframe: Baseline and 8 months

Population: Participants that were able to complete the questionnaire at specific time point.

Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.

Outcome measures

Measure	Treatment (SBRT) n=31 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) n=32 Participants After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Quality of Life as Assessed by EPIC Scores Urinary Incontenence Domain	83.2 score on a scale Standard Deviation 16.5	85.7 score on a scale Standard Deviation 17.3
Quality of Life as Assessed by EPIC Scores Bowel Domain	90.5 score on a scale Standard Deviation 12.4	86.6 score on a scale Standard Deviation 19.3
Quality of Life as Assessed by EPIC Scores Sexual Function Domain	46.4 score on a scale Standard Deviation 30.4	37.5 score on a scale Standard Deviation 29.0
Quality of Life as Assessed by EPIC Scores Hormonal Domain	80.6 score on a scale Standard Deviation 19.4	82.4 score on a scale Standard Deviation 16.7

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Participants that were able to complete the questionnaire at specific time point.

Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.

Outcome measures

Measure	Treatment (SBRT) n=31 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) n=34 Participants After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Quality of Life as Assessed by EPIC Scores Urinary Incontenence Domain	83.2 score on a scale Standard Deviation 16.5	83.4 score on a scale Standard Deviation 19.4
Quality of Life as Assessed by EPIC Scores Bowel Domain	90.5 score on a scale Standard Deviation 12.4	86.3 score on a scale Standard Deviation 18.4
Quality of Life as Assessed by EPIC Scores Sexual Function Domain	46.4 score on a scale Standard Deviation 30.4	37.1 score on a scale Standard Deviation 28.5
Quality of Life as Assessed by EPIC Scores Hormonal Domain	80.6 score on a scale Standard Deviation 19.4	87.3 score on a scale Standard Deviation 12.3

SECONDARY outcome

Timeframe: Baseline and 1.5 months

Population: Participants that were able to complete the questionnaire at specific time point.

Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.

Outcome measures

Measure	Treatment (SBRT) n=32 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Quality of Life as Assessed by Change in AUA Scores	9 score on a scale Interval 1.0 to 25.0	—

SECONDARY outcome

Timeframe: Baseline and 4 months

Population: Participants that were able to complete the questionnaire at specific time point.

Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.

Outcome measures

Measure	Treatment (SBRT) n=32 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Quality of Life as Assessed by Change in AUA Scores	7.5 score on a scale Interval 0.0 to 29.0	—

SECONDARY outcome

Timeframe: Baseline and 8 months

Population: Participants that were able to complete the questionnaire at specific time point.

Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.

Outcome measures

Measure	Treatment (SBRT) n=31 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Quality of Life as Assessed by Change in AUA Scores	6 score on a scale Interval 0.0 to 21.0	—

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Participants that were able to complete the questionnaire at specific time point.

Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.

Outcome measures

Measure	Treatment (SBRT) n=33 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Quality of Life as Assessed by Change in AUA Scores	8 score on a scale Interval 0.0 to 33.0	—

SECONDARY outcome

Timeframe: Baseline and 1.5 months

Population: participants who had a PSA values up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.

Percentage of Participants with biochemical failure. Biochemical failure is defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.

Outcome measures

Measure	Treatment (SBRT) n=29 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	100 percentage of participants Interval 100.0 to 100.0	—

SECONDARY outcome

Timeframe: Baseline and 4 months

Population: participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.

Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.

Outcome measures

Measure	Treatment (SBRT) n=29 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	100 percentage of participants Interval 100.0 to 100.0	—

SECONDARY outcome

Timeframe: Baseline and 8 months

Population: participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.

Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.

Outcome measures

Measure	Treatment (SBRT) n=27 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	96.5 percentage of participants Interval 89.7 to 100.0	—

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.

Percent measurement of biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.

Outcome measures

Measure	Treatment (SBRT) n=27 Participants Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies	After Treatment (SBRT) After treatment (SBRT) Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA	96.5 percentage of participants Interval 89.7 to 100.0	—

Adverse Events

Treatment (SBRT)

Serious events: 1 serious events

Other events: 34 other events

Deaths: 1 deaths

Serious adverse events

Measure	Treatment (SBRT) n=35 participants at risk Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Infections and infestations Prostate infection	2.9% 1/35 • Number of events 1 • Adverse event data collect from participants up to 1 year in follow-up.

Other adverse events

Measure	Treatment (SBRT) n=35 participants at risk Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-20 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity. stereotactic body radiation therapy: Undergo SBRT quality-of-life assessment: Ancillary studies laboratory biomarker analysis: Correlative studies
Musculoskeletal and connective tissue disorders Back pain	2.9% 1/35 • Number of events 1 • Adverse event data collect from participants up to 1 year in follow-up.
Psychiatric disorders Depression	2.9% 1/35 • Number of events 1 • Adverse event data collect from participants up to 1 year in follow-up.
Injury, poisoning and procedural complications Dermatitis radiation	5.7% 2/35 • Number of events 2 • Adverse event data collect from participants up to 1 year in follow-up.
Gastrointestinal disorders Diarrhea	17.1% 6/35 • Number of events 6 • Adverse event data collect from participants up to 1 year in follow-up.
Reproductive system and breast disorders Erectile dysfunction	2.9% 1/35 • Number of events 1 • Adverse event data collect from participants up to 1 year in follow-up.
General disorders Fatigue	42.9% 15/35 • Number of events 16 • Adverse event data collect from participants up to 1 year in follow-up.
Renal and urinary disorders Hematuria	8.6% 3/35 • Number of events 3 • Adverse event data collect from participants up to 1 year in follow-up.
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 1/35 • Number of events 1 • Adverse event data collect from participants up to 1 year in follow-up.
Gastrointestinal disorders Proctitis	17.1% 6/35 • Number of events 7 • Adverse event data collect from participants up to 1 year in follow-up.
Gastrointestinal disorders Rectal hemorrhage	2.9% 1/35 • Number of events 1 • Adverse event data collect from participants up to 1 year in follow-up.
Renal and urinary disorders Dysuria	5.7% 2/35 • Number of events 3 • Adverse event data collect from participants up to 1 year in follow-up.
Renal and urinary disorders Urinary frequency	51.4% 18/35 • Number of events 22 • Adverse event data collect from participants up to 1 year in follow-up.
Renal and urinary disorders Urinary incontinence	20.0% 7/35 • Number of events 7 • Adverse event data collect from participants up to 1 year in follow-up.
Renal and urinary disorders Urinary retention	37.1% 13/35 • Number of events 14 • Adverse event data collect from participants up to 1 year in follow-up.
Renal and urinary disorders Urinary tract pain	20.0% 7/35 • Number of events 9 • Adverse event data collect from participants up to 1 year in follow-up.
Renal and urinary disorders Urinary urgency	40.0% 14/35 • Number of events 17 • Adverse event data collect from participants up to 1 year in follow-up.
Investigations Weight gain	2.9% 1/35 • Number of events 1 • Adverse event data collect from participants up to 1 year in follow-up.

Additional Information

Kevin Stephans MD

Case Comprehensive Cancer Center

Phone: 216-445-8285

Email: stephak@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place