Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02353832
• Collaborator: (none)
• Enrollment: 44
• Locations: 2
• Arm: 1
• Actual Duration (Months): 74
• Patients Per Site: 22
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose is to determine if use of rectal spacers are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects. It is also to determine whether it provides sufficient dosimetric benefits to warrant further clinical investigation in future SABR (Stereotactic Ablative Body Radiation) related clinical studies.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Device: Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)	Phase 2

Detailed Description

A phase II study to assess safety and efficacy of the spacer injection process, ability of the spacer to effectively provide the space necessary to reduce acute events in the rectum, and also meet the SABR based rectal constraints, and to monitor stability of this process during SABR. Unlike IMRT, which uses smaller dose/fraction, when using such high dose/fraction, even a few mm of shift in spacer positioning may impact the dose that the rectum receives, and therefore, a rigorous study of stability of material during the SABR treatments will need to be determined. If there is some shift, by doing this study, we may be able to determine the margin of error that will be necessary in considering rectal organ dosimetry, based on the possible shift in positiong that may occur with the spacer over time.

As the SABR therapy is strictly local, we will select for patients with prostate cancer locally confined to the prostate gland. As such, we will select eligibility criteria of low risk patients to minimize risk of extraprostatic spread, seminal vesicle invasion, and nodal spread. Hormonal therapy may also be used to shrink prostates that are massively enlarged as this may also help further reduce length of rectum that will be irradiated. As the primary toxicity will likely be mucosal damage, we will avoid enrolling patients with pre-existing mucosal dysfunction (including those with previous radiation, TURP, very large prostate glands, inflammatory bowel disease) and immunosuppressed individuals based on our phase I experience[13]. In this way, patients will be uniformly selected in a fashion that would identify patients likely to receive benefit from the therapy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer
• Actual Study Start Date: Nov 6, 2014
• Actual Primary Completion Date: Jan 29, 2018
• Actual Study Completion Date: Jan 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: No Arm Study did not have Arm(s)	Device: Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent); Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Reduction in Acute Per-prostatic Rectal Ulcer Events Events From 90%+ to <70% (Particularly in the Anterior Rectum) [Median 9 months within the end of radiation treatment]

   The effectiveness of rectal spacer use was measured to determine if they are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects

2. Effectiveness of Space Creation of >= 7.5 mm in Protecting Rectum From Toxicity [Median 9 months within the end of radiation treatment]

   The effectiveness of rectal spacer use was measured to determine if they are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects

Secondary Outcome Measures

1. Percentage of Participants With Spacer Related Acute Toxicity [270 days]

   Assess spacer related acute toxicity. Spacer related toxicity could be related to the procedure itself (bleeding, infection, pain), or secondary effects of spacer (erectile dysfunction, persistent pain and discomfort). Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.

2. Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 39 Gy [1 month]

   Determine spacer's ability to change percent rectal circumference (PRC) receiving 39 Gy by at least 50%. This will be determined by using CT planning studies for dosimetric analysis before and after spacer placement.

3. Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 24 Gy. [1 month]

   Determine spacer's ability to change percent rectal circumference (PRC) receiving 24 and 39 Gy by at least 50%. This will be determined by using CT planning studies for dosimetric analysis before and after spacer placement.

4. Acute (Within 270 Days of Treatment) SABR-related Gastrointestinal (GI) Toxicities [270 days]

   Acute gastrointestinal (GI) toxicity is defined as grade 1-5 toxicity occurring prior to 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0.

5. Acute (Within 270 Days of Treatment) SABR-related Genitourinary (GU) Toxicities [270 days]

   Acute genitourinary (GU)toxicity is defined as grade 1-5 toxicity occurring prior to 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0.

6. Chronic (>270 Days From Treatment) SABR-related Genitourinary (GU) Toxicities [From day 271 up to 540 days]

   Delayed genitourinary (GU) toxicity is defined as grade 1-5 toxicity occurring after 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.

7. Chronic (>270 Days From Treatment) SABR-related Gastrointestinal (GI) Toxicities [From day 271 up to 540 days]

   Delayed gastrointestinal (GI) toxicity is defined as grade 1-5 toxicity occurring after 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.

8. Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity- Irritative [270 days]

   Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.

9. Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive [270 days]

   Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.

10. Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. [270 days]

    Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.

11. Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive. [From day 271 up to 540 days]

    Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.

12. Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. [From day 271 up to 540 days]

    Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.

13. Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Irritative. [From day 271 up to 540 days]

    Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.

14. Freedom From Biochemical Recurrence [4 year]

    Biochemical failure RTOG-ASTRO definition (also known as Phoenix definition) - Thus, when the PSA rises by more than 2 ng/ml above the lowest level (nadir) achieved after treatment, biochemical failure has occurred and the date of the failure is recorded at the time the nadir plus 2 ng/ml level is reached

15. Overall Survival [5 year]

    Overall survival as measured by percentage of participants who survived at 5 years. The survival time will be measured from the date of accession to the date of death.

16. Disease-specific Survival [5 year]

    Percentage of patients who did not die from prostate cancer at 5 years.

17. Local Relapse [3 year]

    Percentage of patients without local relapse at 3 years. Local relapse will be measured from the date of study entry to the date of documented local relapse as determined by clinical exam.

18. Regional Relapse [3 years]

    Percentage of patients without regional relapse at 3 years. Regional relapse will be measured from the date of study entry to the date of documented regional nodal recurrence or distant disease relapse.

19. Distant Relapse [3 years]

    Percentage of patients without distant relapse at 3 years. Distant relapse will be measured from the date of study entry to the date of documented regional nodal recurrence or distant disease relapse.

20. EPIC (Expanded Prostate Cancer Index Composite) Bowel Function [18 months]

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0 (worst) -100 (best)). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

21. EPIC (Expanded Prostate Cancer Index Composite) Bowel Frequency [18 months]

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

22. EPIC (Expanded Prostate Cancer Index Composite) Bloody Stools [18 months]

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

23. EPIC (Expanded Prostate Cancer Index Composite) Bowel Habits [18 months]

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

24. EPIC (Expanded Prostate Cancer Index Composite) Bowel Urgency [18 months]

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

25. EPIC (Expanded Prostate Cancer Index Composite) Bowel Leakage/Fecal Incontinence [18 months]

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

26. EPIC (Expanded Prostate Cancer Index Composite) Bowel Pelvic/Rectal Pain [18 months]

    Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).

27. EPIC (Expanded Prostate Cancer Index Composite) Urinary Function [18 months]

    Outcomes for urinary function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) urinary function score (range, 0 (worst)-100 (best)). EPIC urinary irritation or obstruction (range, 0-100).EPIC urinary incontinence (range, 0-100).

28. EPIC (Expanded Prostate Cancer Index Composite) Urinary Irritative/Obstructive [18 months]

    Outcomes for urinary function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) urinary function score (range, 0-100). EPIC urinary irritation or obstruction (range, 0 (worst)-100 (best)).EPIC urinary incontinence (range, 0-100).

29. EPIC (Expanded Prostate Cancer Index Composite) Urinary Incontinence [18 months]

    Outcomes for urinary function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) urinary function score (range, 0-100). EPIC urinary irritation or obstruction (range, 0-100).EPIC urinary incontinence (range, 0 (worst)-100 (best)).

30. AUA (American Urological Association) Quality of Life Questionnaire [18 months]

    AUA Questionnaire is used to measure urinary symptoms. AUA uses a 7-item self-report measure used to assess urinary urgency, frequency, and voiding symptoms. SYMPTOM SCORE: 0-7 (Mild) 8-19 (Moderate) 20-35 (Severe)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All patients must be willing and capable to provide informed consent to participate in the protocol.

• Eligible patients must have appropriate staging studies identifying them as AJCC stage T1 (a, b, or c) or T2a or T2b adenocarcinoma of the prostate gland. The patient should not have direct evidence of regional or distant metastases after appropriate staging studies. Histologic confirmation of cancer will be required by biopsy performed within 180 days of registration.

• The patient's Zubrod performance status must be 0-2.

• The Gleason score should be less than or equal to 6 or 3+4 if < 50% of a 12 core biopsy was involved.

• The serum PSA should be less than or equal to 10 ng/ml.

• Study entry PSA must not be obtained during the following time frames: 10 day period following prostate biopsy; following initiation of ADT; within 30 days after discontinuation of finasteride; or within 90 days after discontinuation of dutasteride.

• Age ≥ 18 years.

• Patients may have used prior hormonal therapy, but it should be limited to no more than 9 months of therapy prior to enrollment.

• The ultrasound, or CT based volume estimation of the patient's prostate gland should be ≤ 60 grams.

Exclusion Criteria:

• Subjects who have had previous pelvic radiotherapy or have had chemotherapy or surgery for prostate cancer.

• Subjects who have plans to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as part of the treatment of prostate cancer.

• Subjects who have undergone previous transurethral resection of the prostate (TURP) or cryotherapy to the prostate. Subjects who have significant urinary obstructive symptoms; AUA score must be ≤15 (alpha blockers allowed).

• Subjects who have a history of significant psychiatric illness.

• Men of reproductive potential who do not agree that they or their partner will use an effective contraceptive method such as condom/diaphragm and spermacidal foam, intrauterine device (IUD), or prescription birth control pills.

• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible).

• Severe, active co-morbidity, defined as follows:

• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.

• Transmural myocardial infarction within the last 6 months.

• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.

• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.

• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.

• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.

• Patients with history of inflammatory colitis (including Crohn's Disease and Ulcerative colitis) are not eligible.

• Subjects with a known allergy to polyethylene glycol hydrogel (spacer material) or contraindication to spacer products (Duraseal or SpaceOAR).

• Subjects with evidence of extraprostatic extension (T3a) or seminal vesicle involvement (T3b) on clinical evaluation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
2	UT Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Michael Folkert, MD, UT Southwestern Medical Center
• Principal Investigator: Michael Zelefsky, MD, Memorial Sloan Kettering Cancer Centre

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 9, 2019

More Information

Publications

None provided.

• Responsible Party: Michael Folkert, Associate Professor of Medicine, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02353832
• Other Study ID Numbers: STU 092013-013
• First Posted: Feb 3, 2015
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Period Title: Overall Study
STARTED	44
COMPLETED	42
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product
Overall Participants	44
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	27 61.4%
>=65 years	17 38.6%
Age (YEARS) [Mean (Full Range) ]
Mean (Full Range) [YEARS]	70
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	44 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	41 93.2%
Unknown or Not Reported	3 6.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	1 2.3%
Black or African American	8 18.2%
White	33 75%
More than one race	0 0%
Unknown or Not Reported	2 4.5%
Region of Enrollment (participants) [Number]
United States	44 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Reduction in Acute Per-prostatic Rectal Ulcer Events Events From 90%+ to <70% (Particularly in the Anterior Rectum)
Description	The effectiveness of rectal spacer use was measured to determine if they are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects
Time Frame	Median 9 months within the end of radiation treatment

Outcome Measure Data

Analysis Population Description

Observed ulceration rate

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Number [percentage of participants]	13.6 30.9%

2. Primary Outcome

Title	Effectiveness of Space Creation of >= 7.5 mm in Protecting Rectum From Toxicity
Description	The effectiveness of rectal spacer use was measured to determine if they are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects
Time Frame	Median 9 months within the end of radiation treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Median (Full Range) [mm]	11.5

3. Secondary Outcome

Title	Percentage of Participants With Spacer Related Acute Toxicity
Description	Assess spacer related acute toxicity. Spacer related toxicity could be related to the procedure itself (bleeding, infection, pain), or secondary effects of spacer (erectile dysfunction, persistent pain and discomfort). Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Grade I	0 0%
Grade II	0 0%
Grade III	2.3 5.2%
Grade VI	0 0%
Grade V	0 0%

4. Secondary Outcome

Title	Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 39 Gy
Description	Determine spacer's ability to change percent rectal circumference (PRC) receiving 39 Gy by at least 50%. This will be determined by using CT planning studies for dosimetric analysis before and after spacer placement.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	8
Mean (Full Range) [percent rectal circumference]	99.8

5. Secondary Outcome

Title	Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 24 Gy.
Description	Determine spacer's ability to change percent rectal circumference (PRC) receiving 24 and 39 Gy by at least 50%. This will be determined by using CT planning studies for dosimetric analysis before and after spacer placement.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	8
Mean (Full Range) [percent rectal circumference]	59.3

6. Secondary Outcome

Title	Acute (Within 270 Days of Treatment) SABR-related Gastrointestinal (GI) Toxicities
Description	Acute gastrointestinal (GI) toxicity is defined as grade 1-5 toxicity occurring prior to 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0.
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Grade I	58.1 132%
Grade II	23.3 53%
Grade III	0 0%
Grade IV	0 0%
Grade V	0 0%

7. Secondary Outcome

Title	Acute (Within 270 Days of Treatment) SABR-related Genitourinary (GU) Toxicities
Description	Acute genitourinary (GU)toxicity is defined as grade 1-5 toxicity occurring prior to 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0.
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Grade I	65.1 148%
Grade II	46.5 105.7%
Grade III	2.3 5.2%
Grade IV	0 0%
Grade V	0 0%

8. Secondary Outcome

Title	Chronic (>270 Days From Treatment) SABR-related Genitourinary (GU) Toxicities
Description	Delayed genitourinary (GU) toxicity is defined as grade 1-5 toxicity occurring after 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.
Time Frame	From day 271 up to 540 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	42
Grade I	64.3 146.1%
Grade II	33.3 75.7%
Grade III	2.4 5.5%
Grade IV	0 0%
Grade V	0 0%

9. Secondary Outcome

Title	Chronic (>270 Days From Treatment) SABR-related Gastrointestinal (GI) Toxicities
Description	Delayed gastrointestinal (GI) toxicity is defined as grade 1-5 toxicity occurring after 270 days from the start of protocol treatment. It is graded based on CTCAE v4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.
Time Frame	From day 271 up to 540 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	42
Grade I	33.3 75.7%
Grade II	14.3 32.5%
Grade III	0 0%
Grade IV	0 0%
Grade V	0 0%

10. Secondary Outcome

Title	Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity- Irritative
Description	Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Grade I	44.2 100.5%
Grade II	37.2 84.5%
Grade III	2.3 5.2%
Grade IV	0 0%
Grade V	0 0%

11. Secondary Outcome

Title	Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive
Description	Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Grade I	41.9 95.2%
Grade II	11.6 26.4%
Grade III	0 0%
Grade IV	0 0%
Grade V	0 0%

12. Secondary Outcome

Title	Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive.
Description	Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0.
Time Frame	270 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Grade I	32.6 74.1%
Grade II	14.0 31.8%
Grade III	0 0%
Grade IV	0 0%
Grade V	0 0%

13. Secondary Outcome

Title	Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive.
Description	Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.
Time Frame	From day 271 up to 540 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Grade I	33.3 75.7%
Grade II	14.3 32.5%
Grade III	2.4 5.5%
Grade IV	0 0%
Grade V	0 0%

14. Secondary Outcome

Title	Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive.
Description	Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.
Time Frame	From day 271 up to 540 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Grade I	14.3 32.5%
Grade II	14.3 32.5%
Grade III	0 0%
Grade IV	0 0%
Grade V	0 0%

15. Secondary Outcome

Title	Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Irritative.
Description	Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE V4.0) and version number 4.0 specified in the protocol. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event.
Time Frame	From day 271 up to 540 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Grade I	42.9 97.5%
Grade II	28.6 65%
Grade III	0 0%
Grade IV	0 0%
Grade V	0 0%

16. Secondary Outcome

Title	Freedom From Biochemical Recurrence
Description	Biochemical failure RTOG-ASTRO definition (also known as Phoenix definition) - Thus, when the PSA rises by more than 2 ng/ml above the lowest level (nadir) achieved after treatment, biochemical failure has occurred and the date of the failure is recorded at the time the nadir plus 2 ng/ml level is reached
Time Frame	4 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	44
Number [percentage of participants]	93.8 213.2%

17. Secondary Outcome

Title	Overall Survival
Description	Overall survival as measured by percentage of participants who survived at 5 years. The survival time will be measured from the date of accession to the date of death.
Time Frame	5 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Number [percentage of participants]	95 215.9%

18. Secondary Outcome

Title	Disease-specific Survival
Description	Percentage of patients who did not die from prostate cancer at 5 years.
Time Frame	5 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Number [percentage of participants]	100 227.3%

19. Secondary Outcome

Title	Local Relapse
Description	Percentage of patients without local relapse at 3 years. Local relapse will be measured from the date of study entry to the date of documented local relapse as determined by clinical exam.
Time Frame	3 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Number [percentage of participants]	97.5 221.6%

20. Secondary Outcome

Title	Regional Relapse
Description	Percentage of patients without regional relapse at 3 years. Regional relapse will be measured from the date of study entry to the date of documented regional nodal recurrence or distant disease relapse.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Number [percentage of participants]	97.5 221.6%

21. Secondary Outcome

Title	Distant Relapse
Description	Percentage of patients without distant relapse at 3 years. Distant relapse will be measured from the date of study entry to the date of documented regional nodal recurrence or distant disease relapse.
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Number [percentage of participants]	100 227.3%

22. Secondary Outcome

Title	EPIC (Expanded Prostate Cancer Index Composite) Bowel Function
Description	Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0 (worst) -100 (best)). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Median (Full Range) [score on a scale]	92

23. Secondary Outcome

Title	EPIC (Expanded Prostate Cancer Index Composite) Bowel Frequency
Description	Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Number [percentage of participants]	8.25 18.8%

24. Secondary Outcome

Title	EPIC (Expanded Prostate Cancer Index Composite) Bloody Stools
Description	Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Number [percentage of participants]	0 0%

25. Secondary Outcome

Title	EPIC (Expanded Prostate Cancer Index Composite) Bowel Habits
Description	Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Number [percentage of participants]	25 56.8%

26. Secondary Outcome

Title	EPIC (Expanded Prostate Cancer Index Composite) Bowel Urgency
Description	Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Number [percentage of participants]	12.38 28.1%

27. Secondary Outcome

Title	EPIC (Expanded Prostate Cancer Index Composite) Bowel Leakage/Fecal Incontinence
Description	Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Number [percentage of participants]	4.125 9.4%

28. Secondary Outcome

Title	EPIC (Expanded Prostate Cancer Index Composite) Bowel Pelvic/Rectal Pain
Description	Outcomes for bowel function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) bowel function score (range, 0-100). EPIC bowel urgency (percentages are for men reporting more than a small problem). EPIC bowel frequency (percentages are for men reporting more than a small problem). EPIC bowel leakage or fecal incontinence (percentages are for men having fecal incontinence at least once per week). EPIC bloody stools (percentages are for men having bloody stools half the time or more). EPIC bowel, pelvic, or rectal pain (percentages are for men reporting more than a small problem). EPIC bowel habits (percentages are for men reporting more than a small problem).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Number [percentage of participants]	5 11.4%

29. Secondary Outcome

Title	EPIC (Expanded Prostate Cancer Index Composite) Urinary Function
Description	Outcomes for urinary function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) urinary function score (range, 0 (worst)-100 (best)). EPIC urinary irritation or obstruction (range, 0-100).EPIC urinary incontinence (range, 0-100).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Mean (Full Range) [score on a scale]	90

30. Secondary Outcome

Title	EPIC (Expanded Prostate Cancer Index Composite) Urinary Irritative/Obstructive
Description	Outcomes for urinary function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) urinary function score (range, 0-100). EPIC urinary irritation or obstruction (range, 0 (worst)-100 (best)).EPIC urinary incontinence (range, 0-100).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Mean (Full Range) [score on a scale]	88

31. Secondary Outcome

Title	EPIC (Expanded Prostate Cancer Index Composite) Urinary Incontinence
Description	Outcomes for urinary function and effect on quality of life. Expanded Prostate Cancer Index Composite (EPIC) urinary function score (range, 0-100). EPIC urinary irritation or obstruction (range, 0-100).EPIC urinary incontinence (range, 0 (worst)-100 (best)).
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Mean (Full Range) [score on a scale]	84

32. Secondary Outcome

Title	AUA (American Urological Association) Quality of Life Questionnaire
Description	AUA Questionnaire is used to measure urinary symptoms. AUA uses a 7-item self-report measure used to assess urinary urgency, frequency, and voiding symptoms. SYMPTOM SCORE: 0-7 (Mild) 8-19 (Moderate) 20-35 (Severe)
Time Frame	18 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Measure Participants	43
Median (Inter-Quartile Range) [score on a scale]	8

Adverse Events

Time Frame	All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Arm/Group Title	Single Arm: Injectable Rectal Spacer
Arm/Group Description	Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
All Cause Mortality
	Single Arm: Injectable Rectal Spacer
	Affected / at Risk (%)	# Events
Total	2/44 (4.5%)
Serious Adverse Events
	Single Arm: Injectable Rectal Spacer
	Affected / at Risk (%)	# Events
Total	0/44 (0%)
Other (Not Including Serious) Adverse Events
	Single Arm: Injectable Rectal Spacer
	Affected / at Risk (%)	# Events
Total	20/44 (45.5%)
Gastrointestinal disorders
Abdominal Pain	2/44 (4.5%)
Anal Pain	5/44 (11.4%)
Anorexia	10/44 (22.7%)
Constipation	13/44 (29.5%)
Diarrhea	10/44 (22.7%)
Fecal Incontinence	4/44 (9.1%)
Flatulence	10/44 (22.7%)
Bowel Frequency	10/44 (22.7%)
Bowel Urgency	7/44 (15.9%)
Tenesmus	10/44 (22.7%)
Gastrointestinal Pain	10/44 (22.7%)
Hemorrhoidal Hemorrhage	10/44 (22.7%)
Hemorrhoids	4/44 (9.1%)
Pelvic Pain	10/44 (22.7%)
Perineal Pain	10/44 (22.7%)
Proctitis	16/44 (36.4%)
Rectal Hemorrhage	10/44 (22.7%)
Rectal Pain	13/44 (29.5%)
Rectal Ulcer	7/44 (15.9%)
Telangiectasia	10/44 (22.7%)
General disorders
Anxiety	10/44 (22.7%)
Fatigue	7/44 (15.9%)
Fever	10/44 (22.7%)
Paresthesia	10/44 (22.7%)
Weight Gain	10/44 (22.7%)
Renal and urinary disorders
Bladder Spasm	10/44 (22.7%)
Cystitis Noninfective	8/44 (18.2%)
Genital Edema	10/44 (22.7%)
Hematuria	4/44 (9.1%)
Infection, Site of Spacer	14/44 (31.8%)
Prostatic Infection	2/44 (4.5%)
Prostatic Obstruction	2/44 (4.5%)
Dysuria	10/44 (22.7%)
Urinary Tract Infection	10/44 (22.7%)
Weak Urine Stream	15/44 (34.1%)
Scrotal Pain	10/44 (22.7%)
Urinary Frequency	10/44 (22.7%)
Urinary Incontinence	14/44 (31.8%)
Urinary Obstruction	2/44 (4.5%)
Urinary Retention	13/44 (29.5%)
Urinary Tract Pain	3/44 (6.8%)
Urinary Urgency	14/44 (31.8%)
Decreased Libido	3/44 (6.8%)
Reproductive system and breast disorders
Ejaculation Disorder	5/44 (11.4%)
Erectile Dysfunction	4/44 (9.1%)
Blood in Semen	10/44 (22.7%)
Skin and subcutaneous tissue disorders
Rash Acneiform	10/44 (22.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.