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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Radiotherapy | Experimental | Five fractions of 7.4 Gy each |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT Prostate | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | </= 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 | >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 | </= 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 | >90 days from the end of treatment, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William R Lee, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16648499 | Background | Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006 May 1;24(13):1990-6. doi: 10.1200/JCO.2005.05.2530. | |
| 16160131 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Radiotherapy | Five fractions of 7.4 Gy each 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Radiotherapy | Five fractions of 7.4 Gy each 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 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 | Posted | Count of Participants | Participants | </= 90 days post radiation treatment, a total of 90 days |
|
|
3 years
Only Genitourinary and Gastrointestinal adverse events were reported.
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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 Radiotherapy | Five fractions of 7.4 Gy each 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Proctitis | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment | defined as Grade 3 or higher |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Cahill, BSN RN OCN CCRP | Assistant Research Practice Manager | (919) 668-5211 | joan.cahill@duke.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 | Jun 17, 2013 | Dec 10, 2019 | 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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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
|
| 3 years post-treatment |
| Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233. |
| 17336216 | Background | Madsen BL, Hsi RA, Pham HT, Fowler JF, Esagui L, Corman J. Stereotactic hypofractionated accurate radiotherapy of the prostate (SHARP), 33.5 Gy in five fractions for localized disease: first clinical trial results. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1099-105. doi: 10.1016/j.ijrobp.2006.10.050. |
| 28086825 | Result | Boyer MJ, Papagikos MA, Kiteley R, Vujaskovic Z, Wu J, Lee WR. Toxicity and quality of life report of a phase II study of stereotactic body radiotherapy (SBRT) for low and intermediate risk prostate cancer. Radiat Oncol. 2017 Jan 13;12(1):14. doi: 10.1186/s13014-016-0758-8. |
| years |
|
| 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 |
|
| Participants |
|
|
| Primary | 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 | Posted | Count of Participants | Participants | >90 days from the end of treatment, up to 3 years |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | </= 90 days post radiation treatment, a total of 90 days |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | >90 days from the end of treatment, up to 3 years |
|
|
|
| Secondary | Disease Free Survival | Data not collected. | Posted | 5 yrs |
|
|
| Secondary | 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. | Only participants who provided responses for each domain were analyzed. | Posted | Mean | Standard Deviation | score on a scale | 3 years post-treatment |
|
|
|
| 4 |
| 60 |
| 1 |
| 60 |
| 51 |
| 60 |
|
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE v4.0 | 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 |
| Title | Measurements |
|---|
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| Grade 4 |
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| Grade 5 |
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| Title | Measurements |
|---|
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| Grade 4 |
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| Grade 5 |
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| Title | Measurements |
|---|
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| Grade 4 |
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| Grade 5 |
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| Bowel Domain |
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| Hormonal Domain |
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