Prostate Cancer
Conditions
Brief summary
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.
Detailed description
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
Interventions
RADIATIONSIBRT
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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Biopsy-proven diagnosis of prostate adenocarcinoma 2. NCCN defined low-, intermediate- and high-risk prostate cancer 3. Age ≥ 18 4. Patient must have prostate MRI with a PIRADS 3-5 lesion or PSMA positron emission tomography (PET) with an avid intraprostatic lesion
Exclusion criteria
1. History of prior pelvic radiation (external beam or brachytherapy) 2. Inability to undergo MRI 3. Patients with metastatic disease (other than pelvic lymph nodes) are ineligible for this study 4. American Urological Association (AUA) score \>17 - AUA score \>17
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). | 2 months | 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. |
| Number of Participants Who Received Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost (SIB) Without Greater Than Grade 3 GU/GI Toxicities. | 1month | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. | baseline, 3-6 months post treatment start | 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. |
| American Urological Association (AUA) Questionnaire Will be Assessed. | baseline, 3-6 months post treatment start | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Continuous | 73 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 30 / 30 |
| serious Total, serious adverse events | 1 / 30 |
Outcome results
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.
Time frame: 2 months
Population: Patients who received stereotactic body radiotherapy(SBRT) with simultaneous integrated boost(SIB).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). | Radiation dose - 37.5Gy | 9 Participants |
| Single Arm | Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). | Radiation Dose - 40.0Gy | 14 Participants |
| Single Arm | Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). | Radiation Dose - 42.5Gy | 2 Participants |
| Single Arm | Feasibility of Delivering Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost(SIB). | Radiation Dose - 45Gy | 5 Participants |
95% CI: [14.7, 49.3]
95% CI: [28.3, 65.7]
95% CI: [0.8, 22.1]
95% CI: [5.6, 34.7]
Primary
Number of Participants Who Received Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost (SIB) Without Greater Than Grade 3 GU/GI Toxicities.
Time frame: 1month
Population: Patients who receive radiation dose levels of 37.5, 40, 42.5 or 45 Gy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Number of Participants Who Received Stereotactic Body Radiotherapy(SBRT) With Simultaneous Integrated Boost (SIB) Without Greater Than Grade 3 GU/GI Toxicities. | 30 Participants |
95% CI: [88.4, 100]
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.
Time frame: baseline, 3-6 months post treatment start
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Single Arm | American Urological Association (AUA) Questionnaire Will be Assessed. | Baseline | 6 score on a scale |
| Single Arm | American Urological Association (AUA) Questionnaire Will be Assessed. | 3-6 month post RT | 6 score on a scale |
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.
Time frame: baseline, 3-6 months post treatment start
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Single Arm | Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. | 3-6 months post - Urinary function | 93.1 score on a scale |
| Single Arm | Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. | Baseline Urinary function | 87.9 score on a scale |
| Single Arm | Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. | Baseline Bowel Function | 93.1 score on a scale |
| Single Arm | Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. | Baseline Sexual function | 58.5 score on a scale |
| Single Arm | Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. | Baseline Hormonal Function | 90 score on a scale |
| Single Arm | Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. | 3-6 months post - Bowel Function | 94.2 score on a scale |
| Single Arm | Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. | 3-6 months post - Sexual Function | 53.3 score on a scale |
| Single Arm | Expanded Prostate Cancer Index Composite (EPIC) Quality of Life Questionnaires Will be Assessed in Patients. | 3-6 months post - Hormonal Function | 82.8 score on a scale |