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Patients with metastatic prostate cancer can undergo MRI-guided prostate Stereotactic body radiation therapy (SBRT) without significant adverse events, similar to what has been reported for patients with localized prostate cancer. We hypothesize that prostate SBRT will be well-tolerated in metastatic prostate cancer patients, with quality of life outcomes similar to what has been reported in non-metastatic prostate cancer patients.
The MRidian ViewRay offers delivery of prostate SBRT with real-time MR guidance, which provides superior soft-tissue differentiation with excellent visualization of the prostate. This ViewRay platform offers the ideal setting for this study, that aims at precisely delivering prostate SBRT with a simultaneous integrated boost (when indicated) to visible nodules.
In this study, we hope to demonstrate the safety and feasibility of using 36.25 Gy in 5 fractions, plus a simultaneous integrated boost (when indicated), in patients with metastatic prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR-Guided Prostate SBRT | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-Guided Prostate SBRT | Radiation | Prostate SBRT has become a standard of care for the treatment of localized prostate cancer. 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 when planning is delivered appropriately. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Subjects With Adverse Events Will be Collected | Treatment will be deemed safe if there is no more than 3 acute Grade 3 gasterointestinal/genitourinary events within the first 30 days after treatment completion. Adverse events can be unexpected or expected, related to treatment. | baseline, 3-6months and at 9-12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Questionnaires Will be Assessed. | 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. There are 5 domains, urinary incontinence, urinary Irritative/Obstructive, Bowel, Sexual function and Hormonal. For each domain, the scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes. QOL assessments will occur at baseline, 3-6 months, and at 9-12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Formenti, M.D. | Weill Medical College of Cornell University | 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 | MR-Guided Prostate SBRT | MR-Guided Prostate SBRT: Prostate SBRT has become a standard of care for the treatment of localized prostate cancer. 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 when planning is delivered appropriately. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MR-Guided Prostate SBRT | MR-Guided Prostate SBRT: Prostate SBRT has become a standard of care for the treatment of localized prostate cancer. 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 when planning is delivered appropriately. |
| 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 | Change in Number of Subjects With Adverse Events Will be Collected | Treatment will be deemed safe if there is no more than 3 acute Grade 3 gasterointestinal/genitourinary events within the first 30 days after treatment completion. Adverse events can be unexpected or expected, related to treatment. | Posted | Count of Participants | Participants | baseline, 3-6months and at 9-12 months. |
|
Baseline, 3-6 months, 9-12 months
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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 | MR-Guided Prostate SBRT | MR-Guided Prostate SBRT: Prostate SBRT has become a standard of care for the treatment of localized prostate cancer. 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 when planning is delivered appropriately. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diffused Pruritic Rash | Skin and subcutaneous tissue disorders | CTCAE v5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE v5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharanya Chandrasekhar | Weill Cornell Medicine | 646-962-3110 | shc2043@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 | Aug 1, 2023 | Nov 27, 2023 | 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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|
| baseline, 3-6months and at 9-12 months. |
| Change in The International Prostate Symptom Score (I-PSS) Will be Assessed. | The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicatingincreasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild (symptom score less than of equal to 7) Moderate (symptom score range 8-19) Severe (symptom score range 20-35) | baseline, 3-6months and at 9-12 months. |
| Participants |
|
| Sex: Female, Male | 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 |
|
|
| Secondary | Change in Quality of Life Questionnaires Will be Assessed. | 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. There are 5 domains, urinary incontinence, urinary Irritative/Obstructive, Bowel, Sexual function and Hormonal. For each domain, the scores range from 0 to 100, lower scores indicate worse outcomes and higher EPIC scores represent better outcomes. QOL assessments will occur at baseline, 3-6 months, and at 9-12 months. | 1 patient was not assessed at baseline time point, as the patient had a foley, 4 patients were not assessed at 3-6 months time point, 5 patients were not assessed at 9-12 months time point. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3-6months and at 9-12 months. |
|
|
|
| Secondary | Change in The International Prostate Symptom Score (I-PSS) Will be Assessed. | The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicatingincreasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Mild (symptom score less than of equal to 7) Moderate (symptom score range 8-19) Severe (symptom score range 20-35) | 1 patient was not assessed at baseline time point, as the patient had a foley, 4 patients were not assessed at 3-6 months time point, 5 patients were not assessed at 9-12 months time point. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3-6months and at 9-12 months. |
|
|
|
| 2 |
| 22 |
| 1 |
| 22 |
| 22 |
| 22 |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Bladder incontinence | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE v5.0 | Systematic Assessment |
|
| Lower back pain | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | Systematic Assessment |
|
| Weak Urine Stream | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
|
| Urinary Frequency | Renal and urinary disorders | CTCAE v5.0 | Systematic Assessment |
|
| Appetite change | Gastrointestinal disorders | CTCAE v5.0 | Systematic Assessment |
|
| Anxiety | Nervous system disorders | CTCAE v5.0 | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
|
| Baseline : Bowel |
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| Baseline : Sexual Function |
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| Baseline : Hormonal |
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| 3-6 months : Urinary incontinence |
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| 3-6 months : Urinary Irritative/Obstructive |
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| 3-6 months : Bowel |
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| 3-6 months : Sexual Function |
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| 3-6 months : Hormonal |
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| 9-12 months : Urinary incontinence |
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| 9-12 months : Urinary Irritative/Obstructive |
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| 9-12 months : Bowel |
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| 9-12 months : Sexual Function |
|
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| 9-12 months : Hormonal |
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| 9-12 months |
|
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