Metastatic Prostate Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONMR-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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Biopsy-proven diagnosis of prostate adenocarcinoma * Age ≥ 18 * Must have biopsy-proven metastatic prostate cancer
Exclusion criteria
* History of prior pelvic radiation (external beam or brachytherapy) * Inability to undergo MRI * AUA score \>20 * For patients on systemic therapy, enrollment must be within six months of start of therapy unless exception is made by protocol PIs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Subjects With Adverse Events Will be Collected | baseline, 3-6months and at 9-12 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Questionnaires Will be Assessed. | baseline, 3-6months and at 9-12 months. | 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. |
| Change in The International Prostate Symptom Score (I-PSS) Will be Assessed. | baseline, 3-6months and at 9-12 months. | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | MR-Guided Prostate SBRT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 22 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 22 |
| other Total, other adverse events | 22 / 22 |
| serious Total, serious adverse events | 1 / 22 |
Outcome results
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.
Time frame: baseline, 3-6months and at 9-12 months.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MR-Guided Prostate SBRT | Change in Number of Subjects With Adverse Events Will be Collected | Baseline | 22 Participants |
| MR-Guided Prostate SBRT | Change in Number of Subjects With Adverse Events Will be Collected | 3-6 months | 18 Participants |
| MR-Guided Prostate SBRT | Change in Number of Subjects With Adverse Events Will be Collected | 9-12 months | 17 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.
Time frame: baseline, 3-6months and at 9-12 months.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | 9-12 months : Bowel | 91.6 score on a scale | Standard Deviation 3.68 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | 9-12 months : Sexual Function | 5.7 score on a scale | Standard Deviation 2.05 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | 9-12 months : Hormonal | 72.8 score on a scale | Standard Deviation 0.95 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | 3-6 months : Urinary Irritative/Obstructive | 84.55 score on a scale | Standard Deviation 0.47 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | 3-6 months : Bowel | 92.2 score on a scale | Standard Deviation 3.2 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | 3-6 months : Sexual Function | 4.7 score on a scale | Standard Deviation 2.8 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | 3-6 months : Hormonal | 62.7 score on a scale | Standard Deviation 8.05 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | 9-12 months : Urinary incontinence | 84.9 score on a scale | Standard Deviation 3.08 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | 9-12 months : Urinary Irritative/Obstructive | 82.8 score on a scale | Standard Deviation 0.75 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | Baseline : Urinary incontinence | 80.6 score on a scale | Standard Deviation 22.1 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | Baseline : Urinary Irritative/Obstructive | 83.4 score on a scale | Standard Deviation 15.5 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | Baseline : Bowel | 96.8 score on a scale | Standard Deviation 5.5 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | Baseline : Sexual Function | 8.6 score on a scale | Standard Deviation 14.1 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | Baseline : Hormonal | 74.1 score on a scale | Standard Deviation 19.3 |
| MR-Guided Prostate SBRT | Change in Quality of Life Questionnaires Will be Assessed. | 3-6 months : Urinary incontinence | 84.75 score on a scale | Standard Deviation 2.93 |
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)
Time frame: baseline, 3-6months and at 9-12 months.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MR-Guided Prostate SBRT | Change in The International Prostate Symptom Score (I-PSS) Will be Assessed. | Baseline | 10.7 score on a scale | Standard Deviation 7.9 |
| MR-Guided Prostate SBRT | Change in The International Prostate Symptom Score (I-PSS) Will be Assessed. | 3-6 months | 9 score on a scale | Standard Deviation 1.2 |
| MR-Guided Prostate SBRT | Change in The International Prostate Symptom Score (I-PSS) Will be Assessed. | 9-12 months | 12.2 score on a scale | Standard Deviation 1.12 |