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Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity.
Prostate SBRT is a standard of care treatment for prostate cancer that has not spread to distant metastatic sites. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity. In this initial study, MRI guided treatment planning and delivery will be used to deliver 7 Gy to the entire prostate and seminal vesicles, with a selective boost of additional 0.5, 1.0, 1.5, or 2 Gy per fraction for a total dose of 37.5, 40, 42.5 or 45 Gy to biopsy-proven lesions, defined using MRI.
Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk prostate nodules and deliver a higher radiation dose, to achieve maximal local control without increasing treatment toxicity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | Patients will receive 35 Gy in 5 fractions. Also, patients will receive 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIBRT | Radiation | Patients will receive 35 Gy in 5 fractions. Also, patients will receive 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). | Feasibility of delivering stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB). The investigators will track the number of treatment plans(number of participants) for each dose level (37.5, 40, 42.5, or 45 Gy) that can be delivered while meeting radiation planning objectives. | 2 months |
| Number of Participants Who Received Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost (SIB) Without Greater Than Grade 3 GU/GI Toxicities. | 1month |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. | Health-related quality of life (HRQOL) measured using the Expanded Prostate Cancer Index Composite (EPIC) short-form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
Men with a histologically confirmed diagnosis of non-metastatic prostate adenocarcinoma, meeting the inclusion and exclusion criteria below, and electing to undergo definitive radiation treatment with SBRT, will be eligible for participation in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Josephine Kang, M.D. | Weill Cornell Medicine - New York Presbyterian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). | Feasibility of delivering stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB). The investigators will track the number of treatment plans(number of participants) for each dose level (37.5, 40, 42.5, or 45 Gy) that can be delivered while meeting radiation planning objectives. | Patients who received stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB). | Posted | Count of Participants | Participants | 2 months |
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The adverse events were collected over a time period of 6 months.
The adverse events were collected based on the CTCAEv4.03.
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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 | Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. SIBRT: Patients will receive 35 Gy in 5 fractions. In addition, patients will also receive 0.5-2 Gy per fx for a total dose 37.5, 40, 42.5 or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAEv4.03 | Systematic Assessment | This event is unrelated to the study treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Frequency | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Josephine Kang | Weill Cornell Medicine | 212-746-3607 | jok9106@med.cornell.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 29, 2019 | Oct 26, 2020 | Prot_SAP_000.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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Male patients with a histologically confirmed diagnosis of non-metastatic prostate adenocarcinoma, meeting the inclusion and exclusion criteria below, and electing to undergo definitive radiation treatment with SBRT, will be eligible for participation in this study. Patients will receive 35 Gy in five fractions, also, patients will receive a simultaneous integrated boost from 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. Gastrointestinal/genitourinary toxicities will be assessed at every visit, including quality of life questionnaires and EPIC scores will be assessed at the one month follow up visits.
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| baseline, 3-6 months post treatment start |
| American Urological Association (AUA) Questionnaire Will be Assessed. | Health-related quality of life (HRQOL) measured using the AUA assessment will occur at baseline, and at first follow up. The American Urological Association (AUA) has developed the following questionnaire to help men determine how bothersome their urinary symptoms are and to check how effective their treatment is. 0-7 is mild, 8-19 is moderate and 20-35 is severe. | baseline, 3-6 months post treatment start |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of Participants Who Received Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost (SIB) Without Greater Than Grade 3 GU/GI Toxicities. | Patients who receive radiation dose levels of 37.5, 40, 42.5 or 45 Gy. | Posted | Count of Participants | Participants | 1month |
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| Secondary | Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. | Health-related quality of life (HRQOL) measured using the Expanded Prostate Cancer Index Composite (EPIC) short-form questionnaire. The Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. Scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes. | Each time the HRQOL was administered, anywhere from 6 to 26 participants elected not to complete all the sections of the HRQOL. As such, the number of participants analyzed differs for each time point of HRQOL assessment. | Posted | Mean | Full Range | score on a scale | baseline, 3-6 months post treatment start |
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| Secondary | American Urological Association (AUA) Questionnaire Will be Assessed. | Health-related quality of life (HRQOL) measured using the AUA assessment will occur at baseline, and at first follow up. The American Urological Association (AUA) has developed the following questionnaire to help men determine how bothersome their urinary symptoms are and to check how effective their treatment is. 0-7 is mild, 8-19 is moderate and 20-35 is severe. | Each time the AUA assessment was administered, anywhere from 2 to 3 participants elected not to complete all sections of the AUA assessment. As such, the number of participants analyzed differs for each time point of AUA assessment. | Posted | Median | Full Range | score on a scale | baseline, 3-6 months post treatment start |
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| 0 |
| 30 |
| 1 |
| 30 |
| 30 |
| 30 |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Urethritis | Renal and urinary disorders | Systematic Assessment |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Baseline Sexual function |
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| Baseline Hormonal Function |
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| 3-6 months post - Urinary function |
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| 3-6 months post - Bowel Function |
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| 3-6 months post - Sexual Function |
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| 3-6 months post - Hormonal Function |
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