High-Dose Stereotactic Radiation for Prostate Cancer

• Sponsor: Case Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01664130
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 35
• Location: 1
• Arm: 1
• Actual Duration (Months): 54.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This clinical trial studies high-dose stereotactic body radiation therapy (SBRT) in treating patients with low-, intermediate-, or high-risk localized prostate cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer	Radiation: stereotactic body radiation therapy; Procedure: quality-of-life assessment; Other: laboratory biomarker analysis	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for patients who undergo SBRT for localized prostate cancer.

SECONDARY OBJECTIVES:

1. Follow quality of life after SBRT using Expanded Prostate Cancer Index Composite (EPIC) and American Urological Association (AUA) scores.

2. Assess biochemical control after high-dose SBRT.

OUTLINE:

Patients undergo 5 fractions of prostate stereotactic body radiation therapy over 10-12 days with at least 40 hours between each fraction in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1.5, 4, 8, and 12 months, every 6 months for 4 years, and then annually thereafter.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: High-Dose Stereotactic Body Radiation Therapy in Treating Patients With Low-, Intermediate-, or High-Risk Localized Prostate Cancer
• Actual Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Jan 12, 2017
• Actual Study Completion Date: Jan 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Radiation: stereotactic body radiation therapy; Undergo SBRT; Other Names: SBRT stereotactic radiation therapy stereotactic radiotherapy ; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment ; Other: laboratory biomarker analysis; Correlative studies

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 [1.5 months]

   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

2. Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 [4 months]

   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

3. Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 [8 months]

   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

4. Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0 [12 months]

   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

Secondary Outcome Measures

1. Quality of Life as Assessed by EPIC Scores [Baseline and 1.5 months]

   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.

2. Quality of Life as Assessed by EPIC Scores [Baseline and 4 months]

   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.

3. Quality of Life as Assessed by EPIC Scores [Baseline and 8 months]

   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.

4. Quality of Life as Assessed by EPIC Scores [Baseline and 12 months]

   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.

5. Quality of Life as Assessed by Change in AUA Scores [Baseline and 1.5 months]

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

6. Quality of Life as Assessed by Change in AUA Scores [Baseline and 4 months]

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

7. Quality of Life as Assessed by Change in AUA Scores [Baseline and 8 months]

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

8. Quality of Life as Assessed by Change in AUA Scores [Baseline and 12 months]

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

9. Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA [Baseline and 1.5 months]

   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.

10. Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA [Baseline and 4 months]

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

11. Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA [Baseline and 8 months]

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

12. Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA [Baseline and 12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The patient must have prostate adenocarcinoma proven by histologic diagnosis

• The patient must have clinical stage T1a-T3b with localized prostate cancer considered low, intermediate, or high risk as defined by the National Comprehensive Cancer Network (NCCN) guidelines; any patient whom is defined as high-risk must undergo screening with computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen and pelvis as well as bone scan prior to enrollment for staging purposes; low and intermediate risk patients do not require imaging for staging unless they have a focal symptom warranting investigation

• Performance status - Karnofsky performance status (PS) >= 70

• Life expectancy of > 5 years, in the opinion of and as documented by the investigator

• Patients must either already have fiducials already placed within the prostate, or otherwise be candidates for prostate fiducial placement (no bleeding disorders which may cause excessive bleeding with fiducial placement, INR < 2.0).

• Patients must have prostate-specific antigen (PSA) drawn within the 90 days prior to enrollment

• Men must agree to use adequate contraception (double barrier method of birth control or abstinence) for the duration of study participation and for 12 months after completing treatment

• Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Prior treatment toxicities must be resolved to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

• Patients who are receiving any other investigational agents

• Evidence of metastatic disease prior to radiation

• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Prior pelvic radiation therapy

• Patients whom are planned to receive pelvic nodal radiation are excluded

• Weight > 350 lbs

• Contraindications to placement of fiducials required for high-precision image guidance (e.g. bleeding disorders which may cause excessive bleeding with placement, requirement for coumadin, international normalized ratio [INR] > 2.0)

• Patients unable to maintain a full bladder during treatment

• Previous prostatectomy

• Inflammatory bowel disease

• AUA score > 15 in spite of optimal therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• Case Comprehensive Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Kevin Stephans, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT01664130
• Other Study ID Numbers: CASE1812; NCI-2012-01252
• First Posted: Aug 14, 2012
• Last Update Posted: May 21, 2020
• Last Verified: May 1, 2020

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

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

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
Period Title: Overall Study
STARTED	35
COMPLETED	33
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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 Participants	35
Age, Customized (Count of Participants)
50-59 yrs	6 17.1%
60-69 yrs	12 34.3%
70-79 yrs	15 42.9%
80-89 yrs	2 5.7%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	35 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	33 94.3%
Unknown or Not Reported	2 5.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	10 28.6%
White	25 71.4%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	35 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
Description	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
Time Frame	1.5 months

Outcome Measure Data

Analysis Population Description

All patients that received treatment

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
Measure Participants	35
Count of Participants [Participants]	1 2.9%

2. Primary Outcome

Title	Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
Description	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
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
Measure Participants	35
Count of Participants [Participants]	0 0%

3. Primary Outcome

Title	Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
Description	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
Time Frame	8 months

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
Measure Participants	35
Count of Participants [Participants]	0 0%

4. Primary Outcome

Title	Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0
Description	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
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All patients that received treatment

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
Measure Participants	35
Count of Participants [Participants]	0 0%

5. Secondary Outcome

Title	Quality of Life as Assessed by EPIC Scores
Description	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.
Time Frame	Baseline and 1.5 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baseline	After Treatment (SBRT)
Arm/Group Description	Before treatment	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
Measure Participants	31	32
Urinary Incontenence Domain	83.2 (16.5)	84.0 (18.7)
Bowel Domain	90.5 (12.4)	83.7 (22.7)
Sexual Function Domain	46.4 (30.4)	36.8 (28.3)
Hormonal Domain	80.6 (19.4)	76.6 (20.7)

6. Secondary Outcome

Title	Quality of Life as Assessed by EPIC Scores
Description	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.
Time Frame	Baseline and 4 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baseline	After Treatment (SBRT)
Arm/Group Description	Before treatment	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
Measure Participants	32	33
Urinary Incontenence Domain	83.2 (16.5)	85.0 (16.3)
Bowel Domain	90.5 (12.4)	85.6 (21.1)
Sexual Function Domain	46.4 (30.4)	33.6 (31.1)
Hormonal Domain	80.6 (19.4)	79.4 (22.6)

7. Secondary Outcome

Title	Quality of Life as Assessed by EPIC Scores
Description	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.
Time Frame	Baseline and 8 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baseline	After Treatment (SBRT)
Arm/Group Description	Before treatment.	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
Measure Participants	31	32
Urinary Incontenence Domain	83.2 (16.5)	85.7 (17.3)
Bowel Domain	90.5 (12.4)	86.6 (19.3)
Sexual Function Domain	46.4 (30.4)	37.5 (29.0)
Hormonal Domain	80.6 (19.4)	82.4 (16.7)

8. Secondary Outcome

Title	Quality of Life as Assessed by EPIC Scores
Description	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.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baseline	After Treatment (SBRT)
Arm/Group Description	Before treatment.	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
Measure Participants	31	34
Urinary Incontenence Domain	83.2 (16.5)	83.4 (19.4)
Bowel Domain	90.5 (12.4)	86.3 (18.4)
Sexual Function Domain	46.4 (30.4)	37.1 (28.5)
Hormonal Domain	80.6 (19.4)	87.3 (12.3)

9. Secondary Outcome

Title	Quality of Life as Assessed by Change in AUA Scores
Description	Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.
Time Frame	Baseline and 1.5 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
Measure Participants	32
Median (Full Range) [score on a scale]	9

10. Secondary Outcome

Title	Quality of Life as Assessed by Change in AUA Scores
Description	Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.
Time Frame	Baseline and 4 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
Measure Participants	32
Median (Full Range) [score on a scale]	7.5

11. Secondary Outcome

Title	Quality of Life as Assessed by Change in AUA Scores
Description	Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.
Time Frame	Baseline and 8 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
Measure Participants	31
Median (Full Range) [score on a scale]	6

12. Secondary Outcome

Title	Quality of Life as Assessed by Change in AUA Scores
Description	Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
Measure Participants	33
Median (Full Range) [score on a scale]	8

13. Secondary Outcome

Title	Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
Description	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.
Time Frame	Baseline and 1.5 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
Measure Participants	29
Number (95% Confidence Interval) [percentage of participants]	100 285.7%

14. Secondary Outcome

Title	Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
Description	Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.
Time Frame	Baseline and 4 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
Measure Participants	29
Number (95% Confidence Interval) [percentage of participants]	100 285.7%

15. Secondary Outcome

Title	Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
Description	Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.
Time Frame	Baseline and 8 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
Measure Participants	27
Number (95% Confidence Interval) [percentage of participants]	96.5 275.7%

16. Secondary Outcome

Title	Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA
Description	Percent measurement of biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
Measure Participants	27
Number (95% Confidence Interval) [percentage of participants]	96.5 275.7%

Adverse Events

Time Frame	Adverse event data collect from participants up to 1 year in follow-up.
Arm/Group Title	Treatment (SBRT)
Arm/Group Description	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
All Cause Mortality
	Treatment (SBRT)
	Affected / at Risk (%)	# Events
Total	1/35 (2.9%)
Serious Adverse Events
	Treatment (SBRT)
	Affected / at Risk (%)	# Events
Total	1/35 (2.9%)
Infections and infestations
Prostate infection	1/35 (2.9%)	1
Other (Not Including Serious) Adverse Events
	Treatment (SBRT)
	Affected / at Risk (%)	# Events
Total	34/35 (97.1%)
Gastrointestinal disorders
Diarrhea	6/35 (17.1%)	6
Proctitis	6/35 (17.1%)	7
Rectal hemorrhage	1/35 (2.9%)	1
General disorders
Fatigue	15/35 (42.9%)	16
Injury, poisoning and procedural complications
Dermatitis radiation	2/35 (5.7%)	2
Investigations
Weight gain	1/35 (2.9%)	1
Musculoskeletal and connective tissue disorders
Back pain	1/35 (2.9%)	1
Pain in extremity	1/35 (2.9%)	1
Psychiatric disorders
Depression	1/35 (2.9%)	1
Renal and urinary disorders
Hematuria	3/35 (8.6%)	3
Dysuria	2/35 (5.7%)	3
Urinary frequency	18/35 (51.4%)	22
Urinary incontinence	7/35 (20%)	7
Urinary retention	13/35 (37.1%)	14
Urinary tract pain	7/35 (20%)	9
Urinary urgency	14/35 (40%)	17
Reproductive system and breast disorders
Erectile dysfunction	1/35 (2.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.