Trial Outcomes & Findings for Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer (NCT NCT02353832)

Last Updated: 2022-03-25

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

Median 9 months within the end of radiation treatment

Results posted on

2022-03-25

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm: Injectable Rectal Spacer Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Overall Study STARTED	44
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm: Injectable Rectal Spacer Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Overall Study Ineligible after enrollment	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm: Injectable Rectal Spacer n=44 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	70 YEARS n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 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	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Median 9 months within the end of radiation treatment

Population: Observed ulceration rate

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Percentage of Participants With Reduction in Acute Per-prostatic Rectal Ulcer Events Events From 90%+ to <70% (Particularly in the Anterior Rectum)	13.6 percentage of participants

PRIMARY outcome

Timeframe: Median 9 months within the end of radiation treatment

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Effectiveness of Space Creation of >= 7.5 mm in Protecting Rectum From Toxicity	11.5 mm Interval 6.6 to 21.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Percentage of Participants With Spacer Related Acute Toxicity Grade I	0 percentage of participants
Percentage of Participants With Spacer Related Acute Toxicity Grade II	0 percentage of participants
Percentage of Participants With Spacer Related Acute Toxicity Grade III	2.3 percentage of participants
Percentage of Participants With Spacer Related Acute Toxicity Grade VI	0 percentage of participants
Percentage of Participants With Spacer Related Acute Toxicity Grade V	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=8 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 39 Gy	99.8 percent rectal circumference Interval 41.0 to 100.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=8 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 24 Gy.	59.3 percent rectal circumference Interval 24.2 to 95.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Acute (Within 270 Days of Treatment) SABR-related Gastrointestinal (GI) Toxicities Grade I	58.1 percentage of participants
Acute (Within 270 Days of Treatment) SABR-related Gastrointestinal (GI) Toxicities Grade II	23.3 percentage of participants
Acute (Within 270 Days of Treatment) SABR-related Gastrointestinal (GI) Toxicities Grade III	0 percentage of participants
Acute (Within 270 Days of Treatment) SABR-related Gastrointestinal (GI) Toxicities Grade IV	0 percentage of participants
Acute (Within 270 Days of Treatment) SABR-related Gastrointestinal (GI) Toxicities Grade V	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Acute (Within 270 Days of Treatment) SABR-related Genitourinary (GU) Toxicities Grade I	65.1 percentage of participants
Acute (Within 270 Days of Treatment) SABR-related Genitourinary (GU) Toxicities Grade II	46.5 percentage of participants
Acute (Within 270 Days of Treatment) SABR-related Genitourinary (GU) Toxicities Grade III	2.3 percentage of participants
Acute (Within 270 Days of Treatment) SABR-related Genitourinary (GU) Toxicities Grade IV	0 percentage of participants
Acute (Within 270 Days of Treatment) SABR-related Genitourinary (GU) Toxicities Grade V	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=42 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Chronic (>270 Days From Treatment) SABR-related Genitourinary (GU) Toxicities Grade I	64.3 percentage of participants
Chronic (>270 Days From Treatment) SABR-related Genitourinary (GU) Toxicities Grade II	33.3 percentage of participants
Chronic (>270 Days From Treatment) SABR-related Genitourinary (GU) Toxicities Grade III	2.4 percentage of participants
Chronic (>270 Days From Treatment) SABR-related Genitourinary (GU) Toxicities Grade IV	0 percentage of participants
Chronic (>270 Days From Treatment) SABR-related Genitourinary (GU) Toxicities Grade V	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=42 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Chronic (>270 Days From Treatment) SABR-related Gastrointestinal (GI) Toxicities Grade I	33.3 percentage of participants
Chronic (>270 Days From Treatment) SABR-related Gastrointestinal (GI) Toxicities Grade II	14.3 percentage of participants
Chronic (>270 Days From Treatment) SABR-related Gastrointestinal (GI) Toxicities Grade III	0 percentage of participants
Chronic (>270 Days From Treatment) SABR-related Gastrointestinal (GI) Toxicities Grade IV	0 percentage of participants
Chronic (>270 Days From Treatment) SABR-related Gastrointestinal (GI) Toxicities Grade V	0 percentage of participants

SECONDARY outcome

Timeframe: 270 days

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

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity- Irritative Grade I	44.2 percentage of participants
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity- Irritative Grade II	37.2 percentage of participants
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity- Irritative Grade III	2.3 percentage of participants
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity- Irritative Grade IV	0 percentage of participants
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity- Irritative Grade V	0 percentage of participants

SECONDARY outcome

Timeframe: 270 days

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

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive Grade I	41.9 percentage of participants
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive Grade II	11.6 percentage of participants
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive Grade III	0 percentage of participants
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive Grade IV	0 percentage of participants
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive Grade V	0 percentage of participants

SECONDARY outcome

Timeframe: 270 days

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

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. Grade I	32.6 percentage of participants
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. Grade II	14.0 percentage of participants
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. Grade III	0 percentage of participants
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. Grade IV	0 percentage of participants
Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. Grade V	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive. Grade I	33.3 percentage of participants
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive. Grade II	14.3 percentage of participants
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive. Grade III	2.4 percentage of participants
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive. Grade IV	0 percentage of participants
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive. Grade V	0 percentage of participants

SECONDARY outcome

Timeframe: From day 271 up to 540 days

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. Grade I	14.3 percentage of participants
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. Grade II	14.3 percentage of participants
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. Grade III	0 percentage of participants
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. Grade IV	0 percentage of participants
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. Grade V	0 percentage of participants

SECONDARY outcome

Timeframe: From day 271 up to 540 days

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Irritative. Grade I	42.9 percentage of participants
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Irritative. Grade II	28.6 percentage of participants
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Irritative. Grade III	0 percentage of participants
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Irritative. Grade IV	0 percentage of participants
Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Irritative. Grade V	0 percentage of participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=44 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Freedom From Biochemical Recurrence	93.8 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Overall Survival	95 percentage of participants

SECONDARY outcome

Timeframe: 5 year

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

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Disease-specific Survival	100 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Local Relapse	97.5 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Regional Relapse	97.5 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Distant Relapse	100 percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
EPIC (Expanded Prostate Cancer Index Composite) Bowel Function	92 score on a scale Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
EPIC (Expanded Prostate Cancer Index Composite) Bowel Frequency	8.25 percentage of participants

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
EPIC (Expanded Prostate Cancer Index Composite) Bloody Stools	0 percentage of participants

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
EPIC (Expanded Prostate Cancer Index Composite) Bowel Habits	25 percentage of participants

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
EPIC (Expanded Prostate Cancer Index Composite) Bowel Urgency	12.38 percentage of participants

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
EPIC (Expanded Prostate Cancer Index Composite) Bowel Leakage/Fecal Incontinence	4.125 percentage of participants

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
EPIC (Expanded Prostate Cancer Index Composite) Bowel Pelvic/Rectal Pain	5 percentage of participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
EPIC (Expanded Prostate Cancer Index Composite) Urinary Function	90 score on a scale Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
EPIC (Expanded Prostate Cancer Index Composite) Urinary Irritative/Obstructive	88 score on a scale Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 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)).

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
EPIC (Expanded Prostate Cancer Index Composite) Urinary Incontinence	84 score on a scale Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Single Arm: Injectable Rectal Spacer n=43 Participants Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
AUA (American Urological Association) Quality of Life Questionnaire	8 score on a scale Interval 4.0 to 12.0

Adverse Events

Single Arm: Injectable Rectal Spacer

Serious events: 0 serious events

Other events: 20 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single Arm: Injectable Rectal Spacer n=44 participants at risk Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Gastrointestinal disorders Abdominal Pain	4.5% 2/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Anal Pain	11.4% 5/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Anorexia	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Constipation	29.5% 13/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Diarrhea	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Fecal Incontinence	9.1% 4/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Flatulence	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Bowel Frequency	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Bowel Urgency	15.9% 7/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Tenesmus	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Gastrointestinal Pain	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Hemorrhoidal Hemorrhage	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Hemorrhoids	9.1% 4/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Pelvic Pain	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Perineal Pain	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Proctitis	36.4% 16/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Rectal Hemorrhage	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Rectal Pain	29.5% 13/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Rectal Ulcer	15.9% 7/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Gastrointestinal disorders Telangiectasia	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Bladder Spasm	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Cystitis Noninfective	18.2% 8/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Genital Edema	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Hematuria	9.1% 4/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Infection, Site of Spacer	31.8% 14/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Prostatic Infection	4.5% 2/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Prostatic Obstruction	4.5% 2/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Dysuria	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Urinary Tract Infection	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Weak Urine Stream	34.1% 15/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Scrotal Pain	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Urinary Frequency	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Urinary Incontinence	31.8% 14/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Urinary Obstruction	4.5% 2/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Urinary Retention	29.5% 13/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Urinary Tract Pain	6.8% 3/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Urinary Urgency	31.8% 14/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Renal and urinary disorders Decreased Libido	6.8% 3/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Reproductive system and breast disorders Ejaculation Disorder	11.4% 5/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Reproductive system and breast disorders Erectile Dysfunction	9.1% 4/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Reproductive system and breast disorders Blood in Semen	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
General disorders Anxiety	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
General disorders Fatigue	15.9% 7/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
General disorders Fever	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
General disorders Paresthesia	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
Skin and subcutaneous tissue disorders Rash Acneiform	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
General disorders Weight Gain	22.7% 10/44 • All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.

Additional Information

Michael Folkert, M.D., Ph.D.

University of Texas Southwestern

Phone: 214-645-8525

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place