An interventional study of SBRT Prostate in Prostate Cancer, sponsored by Duke University. Completed at 1 site in United States. Open to male participants aged 40 Years to 82 Years. Per ClinicalTrials.gov, last updated 2022-01-24.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment.
This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 60 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Five fractions of 7.4 Gy each
Radiation: SBRT Prostate
Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Also known as: Stereotactic body radiation therapy, External beam radiation therapy
Number of Participants With Genitourinary Acute Toxicity
Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment
Time frame: </= 90 days post radiation treatment, a total of 90 days
Number of Participants With Genitourinary Late Toxicity
Genitourinary Late Toxicity is defined as Grade 3 or higher occurring \>90 days from the end of radiation treatment
Time frame: >90 days from the end of treatment, up to 3 years
Number of Participants With Gastrointestinal Acute Toxicity
Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment
Time frame: </= 90 days post radiation treatment, a total of 90 days
Number of Participants With Gastrointestinal Late Toxicity
Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring \> 90 days from the end of radiation treatment
Time frame: >90 days from the end of treatment, up to 3 years
Disease Free Survival
Time frame: 5 yrs
Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form
The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life.
Time frame: 3 years post-treatment
| Milestone | Stereotactic Radiotherapy |
|---|---|
| Started | 60 |
| Completed | 60 |
| Not completed | 0 |
Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment
| Participants | Stereotactic Radiotherapy |
|---|---|
| Grade 1 | 44 |
| Grade 2 | 15 |
| Grade 3 | 0 |
| Grade 4 | 0 |
| Grade 5 | 0 |
Genitourinary Late Toxicity is defined as Grade 3 or higher occurring \>90 days from the end of radiation treatment
| Participants | Stereotactic Radiotherapy |
|---|---|
| Grade 1 | 22 |
| Grade 2 | 4 |
| Grade 3 | 0 |
| Grade 4 | 0 |
| Grade 5 | 0 |
Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment
| Participants | Stereotactic Radiotherapy |
|---|---|
| Grade 1 | 19 |
| Grade 2 | 3 |
| Grade 3 | 0 |
| Grade 4 | 0 |
| Grade 5 | 0 |
Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring \> 90 days from the end of radiation treatment
| Participants | Stereotactic Radiotherapy |
|---|---|
| Grade 1 | 15 |
| Grade 2 | 5 |
| Grade 3 | 1 |
| Grade 4 | 0 |
| Grade 5 | 0 |
No measurements were reported for this outcome.
The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life.
| score on a scale | Stereotactic Radiotherapy |
|---|---|
| Urinary Domain | 94.1 ± 14.7 |
| Sexual Domain | 77.7 ± 27.6 |
| Bowel Domain | 90.2 ± 24.0 |
| Hormonal Domain | 94.4 ± 8.6 |
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stereotactic Radiotherapy | 4/60 (6.7%) | 1/60 (1.7%) | 51/60 (85%) |
| Event | Stereotactic Radiotherapy |
|---|---|
| ProctitisGastrointestinal disorders | 1/60 |
| Event | Stereotactic Radiotherapy |
|---|---|
| Urinary frequencyRenal and urinary disorders | 51/60 |
| Urinary retentionRenal and urinary disorders | 30/60 |
| Urinary urgencyRenal and urinary disorders | 28/60 |
| Urinary tract painRenal and urinary disorders | 22/60 |
| DiarrheaGastrointestinal disorders | 17/60 |
| Rectal hemorrhageGastrointestinal disorders | 14/60 |
| ProctitisGastrointestinal disorders | 9/60 |
| Rectal painGastrointestinal disorders | 5/60 |
| Hemorrhoidal hemorrhageGastrointestinal disorders | 4/60 |
| Age, Continuous(years) | Stereotactic Radiotherapy |
|---|---|
| Median | 66 (49 to 82) |
| Sex: Female, Male(Participants) | Stereotactic Radiotherapy |
|---|---|
| Female | 0 |
| Male | 60 |
| Ethnicity (NIH/OMB)(Participants) | Stereotactic Radiotherapy |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 60 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Stereotactic Radiotherapy |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 17 |
| White | 41 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Stereotactic Radiotherapy |
|---|---|
| United States | 60 |
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