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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Arm | Other | Study did not have Arm(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent) | Device | Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Reduction in Acute Per-prostatic Rectal Ulcer Events Events From 90%+ to <70% (Particularly in the Anterior Rectum) | 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 | Median 9 months within the end of radiation treatment |
| Effectiveness of Space Creation of >= 7.5 mm in Protecting Rectum From Toxicity | 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 | Median 9 months within the end of radiation treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Spacer Related Acute Toxicity | 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. |
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Inclusion Criteria:
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:
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.
Male only study
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| Name | Affiliation | Role |
|---|---|---|
| Michael Folkert, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Michael Zelefsky, MD | Memorial Sloan Kettering Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States | ||
| UT Southwestern Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm: Injectable Rectal Spacer | Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm: Injectable Rectal Spacer | Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Reduction in Acute Per-prostatic Rectal Ulcer Events Events From 90%+ to <70% (Particularly in the Anterior Rectum) | 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 | Observed ulceration rate | Posted | Number | percentage of participants | Median 9 months within the end of radiation treatment |
|
All-Cause Mortality assessed for up to 5 years. Serious and Other Adverse Events assessed for up to 540 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm: Injectable Rectal Spacer | Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Folkert, M.D., Ph.D. | University of Texas Southwestern | 214-645-8525 | Michael.Folkert@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2019 | Oct 27, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 270 days |
| Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 39 Gy | 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. | 1 month |
| Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 24 Gy. | 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. | 1 month |
| Acute (Within 270 Days of Treatment) SABR-related Gastrointestinal (GI) Toxicities | 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. | 270 days |
| Acute (Within 270 Days of Treatment) SABR-related Genitourinary (GU) Toxicities | 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. | 270 days |
| Chronic (>270 Days From Treatment) SABR-related Genitourinary (GU) Toxicities | 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. | From day 271 up to 540 days |
| Chronic (>270 Days From Treatment) SABR-related Gastrointestinal (GI) Toxicities | 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. | From day 271 up to 540 days |
| Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity- Irritative | Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. | 270 days |
| Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive | Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. | 270 days |
| Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. | Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. | 270 days |
| Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive. | 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. | From day 271 up to 540 days |
| Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. | 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. | From day 271 up to 540 days |
| Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Irritative. | 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. | From day 271 up to 540 days |
| Freedom From Biochemical Recurrence | 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 | 4 year |
| Overall Survival | 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. | 5 year |
| Disease-specific Survival | Percentage of patients who did not die from prostate cancer at 5 years. | 5 year |
| Local Relapse | 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. | 3 year |
| Regional Relapse | 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. | 3 years |
| Distant Relapse | 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. | 3 years |
| EPIC (Expanded Prostate Cancer Index Composite) Bowel Function | 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). | 18 months |
| EPIC (Expanded Prostate Cancer Index Composite) Bowel Frequency | 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). | 18 months |
| EPIC (Expanded Prostate Cancer Index Composite) Bloody Stools | 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). | 18 months |
| EPIC (Expanded Prostate Cancer Index Composite) Bowel Habits | 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). | 18 months |
| EPIC (Expanded Prostate Cancer Index Composite) Bowel Urgency | 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). | 18 months |
| EPIC (Expanded Prostate Cancer Index Composite) Bowel Leakage/Fecal Incontinence | 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). | 18 months |
| EPIC (Expanded Prostate Cancer Index Composite) Bowel Pelvic/Rectal Pain | 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). | 18 months |
| EPIC (Expanded Prostate Cancer Index Composite) Urinary Function | 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). | 18 months |
| EPIC (Expanded Prostate Cancer Index Composite) Urinary Irritative/Obstructive | 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). | 18 months |
| EPIC (Expanded Prostate Cancer Index Composite) Urinary Incontinence | 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)). | 18 months |
| AUA (American Urological Association) Quality of Life Questionnaire | 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) | 18 months |
| Dallas |
| Texas |
| 75390 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | YEARS |
|
| Sex: Female, Male | Male only study | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Effectiveness of Space Creation of >= 7.5 mm in Protecting Rectum From Toxicity | 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 | Posted | Median | Full Range | mm | Median 9 months within the end of radiation treatment |
|
|
|
| Secondary | Percentage of Participants With Spacer Related Acute Toxicity | 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. | Posted | Number | percentage of participants | 270 days |
|
|
|
| Secondary | Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 39 Gy | 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. | Posted | Mean | Full Range | percent rectal circumference | 1 month |
|
|
|
| Secondary | Determine Spacer's Ability to Change Percent Rectal Circumference (PRC) Receiving 24 Gy. | 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. | Posted | Mean | Full Range | percent rectal circumference | 1 month |
|
|
|
| Secondary | Acute (Within 270 Days of Treatment) SABR-related Gastrointestinal (GI) Toxicities | 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. | Posted | Number | percentage of participants | 270 days |
|
|
|
| Secondary | Acute (Within 270 Days of Treatment) SABR-related Genitourinary (GU) Toxicities | 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. | Posted | Number | percentage of participants | 270 days |
|
|
|
| Secondary | Chronic (>270 Days From Treatment) SABR-related Genitourinary (GU) Toxicities | 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. | Posted | Number | percentage of participants | From day 271 up to 540 days |
|
|
|
| Secondary | Chronic (>270 Days From Treatment) SABR-related Gastrointestinal (GI) Toxicities | 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. | Posted | Number | percentage of participants | From day 271 up to 540 days |
|
|
|
| Secondary | Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity- Irritative | Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. | Posted | Number | percentage of participants | 270 days |
|
|
|
| Secondary | Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive | Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. | Posted | Number | percentage of participants | 270 days |
|
|
|
| Secondary | Acute Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. | Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. | Posted | Number | percentage of participants | 270 days |
|
|
|
| Secondary | Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Obstructive. | 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. | Posted | Number | percentage of participants | From day 271 up to 540 days |
|
|
|
| Secondary | Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Reproductive. | 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. | Posted | Number | percentage of participants | From day 271 up to 540 days |
|
|
|
| Secondary | Chronic Non-GI (Gastrointestinal) and Non-GU (Genitourinary) Toxicity-Irritative. | 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. | Posted | Number | percentage of participants | From day 271 up to 540 days |
|
|
|
| Secondary | Freedom From Biochemical Recurrence | 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 | Posted | Number | percentage of participants | 4 year |
|
|
|
| Secondary | Overall Survival | 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. | Posted | Number | percentage of participants | 5 year |
|
|
|
| Secondary | Disease-specific Survival | Percentage of patients who did not die from prostate cancer at 5 years. | Posted | Number | percentage of participants | 5 year |
|
|
|
| Secondary | Local Relapse | 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. | Posted | Number | percentage of participants | 3 year |
|
|
|
| Secondary | Regional Relapse | 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. | Posted | Number | percentage of participants | 3 years |
|
|
|
| Secondary | Distant Relapse | 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. | Posted | Number | percentage of participants | 3 years |
|
|
|
| Secondary | EPIC (Expanded Prostate Cancer Index Composite) Bowel Function | 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). | Posted | Median | Full Range | score on a scale | 18 months |
|
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|
| Secondary | EPIC (Expanded Prostate Cancer Index Composite) Bowel Frequency | 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). | Posted | Number | percentage of participants | 18 months |
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| Secondary | EPIC (Expanded Prostate Cancer Index Composite) Bloody Stools | 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). | Posted | Number | percentage of participants | 18 months |
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| Secondary | EPIC (Expanded Prostate Cancer Index Composite) Bowel Habits | 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). | Posted | Number | percentage of participants | 18 months |
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| Secondary | EPIC (Expanded Prostate Cancer Index Composite) Bowel Urgency | 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). | Posted | Number | percentage of participants | 18 months |
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| Secondary | EPIC (Expanded Prostate Cancer Index Composite) Bowel Leakage/Fecal Incontinence | 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). | Posted | Number | percentage of participants | 18 months |
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| Secondary | EPIC (Expanded Prostate Cancer Index Composite) Bowel Pelvic/Rectal Pain | 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). | Posted | Number | percentage of participants | 18 months |
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| Secondary | EPIC (Expanded Prostate Cancer Index Composite) Urinary Function | 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). | Posted | Mean | Full Range | score on a scale | 18 months |
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| Secondary | EPIC (Expanded Prostate Cancer Index Composite) Urinary Irritative/Obstructive | 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). | Posted | Mean | Full Range | score on a scale | 18 months |
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| Secondary | EPIC (Expanded Prostate Cancer Index Composite) Urinary Incontinence | 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)). | Posted | Mean | Full Range | score on a scale | 18 months |
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| Secondary | AUA (American Urological Association) Quality of Life Questionnaire | 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) | Posted | Median | Inter-Quartile Range | score on a scale | 18 months |
|
|
|
| 2 |
| 44 |
| 0 |
| 44 |
| 20 |
| 44 |
| Anal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Loss of Appetite |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fecal Incontinence | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bowel Frequency | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bowel Urgency | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Tenesmus | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastrointestinal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hemorrhoidal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pelvic Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Perineal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rectal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rectal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rectal Ulcer | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Telangiectasia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bladder Spasm | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Cystitis Noninfective | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Genital Edema | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Infection, Site of Spacer | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Prostatic Infection | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Prostatic Obstruction | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
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| Dysuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Urinary Tract Infection | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Weak Urine Stream | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Scrotal Pain | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Urinary Frequency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Urinary Incontinence | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Urinary Obstruction | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Urinary Retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Urinary Tract Pain | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Urinary Urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Non-Sexual Domain |
|
| Decreased Libido | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | Sexual Domain |
|
| Ejaculation Disorder | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment | Sexual Domain |
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| Erectile Dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment | Sexual Domain |
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| Blood in Semen | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment | Sexual Domain |
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| Anxiety | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rash Acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Weight Gain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|
|
| Grade VI |
|
| Grade V |
|
| Title |
|---|
| Measurements |
|---|
|
| Grade IV |
|
| Grade V |
|
| Title |
|---|
| Measurements |
|---|
|
| Grade IV |
|
| Grade V |
|
| Title | Measurements |
|---|---|
|
| Grade IV |
|
| Grade V |
|
| Title | Measurements |
|---|---|
|
| Grade IV |
|
| Grade V |
|
|
| Grade IV |
|
| Grade V |
|
|
| Grade IV |
|
| Grade V |
|
|
| Grade IV |
|
| Grade V |
|
| Title | Measurements |
|---|---|
|
| Grade IV |
|
| Grade V |
|
| Title | Measurements |
|---|---|
|
| Grade IV |
|
| Grade V |
|
| Title | Measurements |
|---|---|
|
| Grade IV |
|
| Grade V |
|