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This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.
This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiotherapy | Other | Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic body radiotherapy | Radiation | Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Control Rate | Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Late Toxicity Rate | Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment. | one year |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Hospital St. Louis | St Louis | Missouri | 63141 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Body Radiotherapy | Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Body Radiotherapy | Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. |
| 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 | Biochemical Control Rate | Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression. | Posted | Count of Participants | Participants | one year |
|
5 years
Adverse event and mortality information collection was limited by 12 study subjects that became unavailable or otherwise did not respond during the course of the 5 year follow-up period. 10 of these 12 study subjects did not make follow-up appointments and were not able to be contacted prior to the end of the first year of follow-up. This caused some discrepancy within the number of patients for whom adverse event data and mortality affects and applies to within the record.
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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 | Stereotactic Body Radiotherapy | Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. stereotactic body radiotherapy: Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GU Bleeding | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Change in urinary frequency | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaymeson Stroud, MD | Mercy | 314-251-6844 | Jaymeson.Stroud@mercy.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 1, 2016 | Sep 2, 2020 | Prot_SAP_ICF_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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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Late Toxicity Rate | Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment. | Posted | Count of Participants | Participants | one year |
|
|
|
| 0 |
| 72 |
| 1 |
| 74 |
| 5 |
| 74 |
| Impotence | Reproductive system and breast disorders | Systematic Assessment |
|
| Dysuria | 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 |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |