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| ID | Type | Description | Link |
|---|---|---|---|
| NCI (P01 CA88960) | |||
| 2002-322 | Other Identifier | Institutional Review Board | |
| A533300 | Other Identifier | UW Madison | |
| SMPH/HUMAN ONCOLOGY | Other Identifier | UW Madison |
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The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources. Phase II will commence with Maximum Tolerated Dose (MTD) finding with up to 200 additional patients being enrolled during this phase of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Level 1 | Experimental | 64.7 Gy/22 fractions of 2.94 Gy |
|
| Level 2 | Experimental | 58.08 Gy/16 fractions of 3.63 Gy |
|
| Level 3 | Experimental | 51.6 Gy/12 fractions of 4.3 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Daily radiation to prescribed dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience Grade 3 or Higher Acute Toxicities | To evaluate acute tolerances to dose-per-fraction escalation in the treatment of prostate cancer using optimized treatment of Intensity-modulated radiation therapy (IMRT), daily rectal balloon displacement, and transabdominal ultrasound localization of the prostate. For toxicities observed within the first 10 patients at each hypofractionation level, ≥20% acute grade 3 or higher GI or genitourinary (GU) toxicity will constitute a threshold toxicity level and will dictate a decrease in frequency of treatment by one treatment per week. Maximum tolerated dose is reached if 20% of participants experience acute toxicities grade 3 or higher. | 90 days post radiation treatment |
| Number of Subjects Experiencing Grade 2 or Higher Late Rectal Toxicities at Any Time During Follow Up | To evaluate late radiation toxicities to dose-per fraction escalation in the treatment of prostate | from 90 days post XRT through last follow-up visit (up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical Progression-free Survival Based on PSA Surveillance | Patients will be considered to be without biochemical recurrence if either the Prostate-specific antigen (PSA) is still declining or the PSA nadir has been reached and is below 1.0ng/ml | up to 15 years from enrollment |
| Fox Chase Bowel Survey at Baseline and 3 Years |
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Inclusion Criteria:
Histologically proven adenocarcinoma of the prostate.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Ritter, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26755165 | Result | Brower JV, Forman JD, Kupelian PA, Petereit DG, Gondi V, Lawton CA, Anger N, Saha S, Chappell R, Ritter MA. Quality of life outcomes from a dose-per-fraction escalation trial of hypofractionation in prostate cancer. Radiother Oncol. 2016 Jan;118(1):99-104. doi: 10.1016/j.radonc.2015.12.018. Epub 2016 Jan 2. |
| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Level 1 | 2.94 gy/fr, 22 fractions, Radiotherapy: Daily radiation to prescribed dose |
| FG001 | Level 2 | 3.63 gy/fr, 16 fractions, 50 patients first 10 treated with 4 fractions per week next 40 treated with 5 fractions per week Radiotherapy: Daily radiation to prescribed dose |
| FG002 | Level 3 | 4.3 gy/fr, 12 fractions, 50 patients first 10 treated with 4 fractions per week next 40 treated with 5 fractions per week Radiotherapy: Daily radiation to prescribed dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Level I | 2.94 gy/fr, 22 fractions, Radiotherapy: Daily radiation to prescribed dose |
| BG001 | Level II | 3.63 gy/fr, 16 fractions, Radiotherapy: Daily radiation to prescribed dose |
| 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 Who Experience Grade 3 or Higher Acute Toxicities | To evaluate acute tolerances to dose-per-fraction escalation in the treatment of prostate cancer using optimized treatment of Intensity-modulated radiation therapy (IMRT), daily rectal balloon displacement, and transabdominal ultrasound localization of the prostate. For toxicities observed within the first 10 patients at each hypofractionation level, ≥20% acute grade 3 or higher GI or genitourinary (GU) toxicity will constitute a threshold toxicity level and will dictate a decrease in frequency of treatment by one treatment per week. Maximum tolerated dose is reached if 20% of participants experience acute toxicities grade 3 or higher. | Posted | Count of Participants | Participants | 90 days post radiation treatment |
|
Acute GI and GU toxicities and Late GI and GU toxicities were recorded for the duration of the study. For level 1 patients, median followup was 100 months, for level 2 patients median follow up was 85.5 months and for level 3 it was 61.7 months
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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 | Level 1 | 2.94 gy/fr, 22 fractions, minimum 50 patients to escalate, (back filling permitted while next dose level data matures for escalation) first 10 treated with 4 fractions per week next 40 + treated with 5 fractions per week Radiotherapy: Daily radiation to prescribed dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute GI | Gastrointestinal disorders | Systematic Assessment | modified RTOG grading criteria |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Trask | University of Wisconsin | 608-263-9528 | trask@humonc.wisc.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 | Jan 11, 2006 | Sep 6, 2018 | 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 |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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dose escalation, 3 possible dose groups, with one Phase II group based on MTD.
Per protocol, while waiting for safety data to mature for escalation, protocol permitted enrollment to continue on last dose that was already proven safe. Thus Arms one and two have more than 50 subjects each.
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The Fox Chase Bowel/Bladder survey was divided into two sections: Bowel (questions 1 to 14, N=14) and Bladder (questions 19, and 21 to 30, N=11). To facilitate analysis, Bowel and Bladder scores for each section were rescaled to a total score of between 0 - 100, where higher scores indicated better Quality of Life (QoL). Results for the Bowel Section are reported here. |
| Baseline and 3 years |
| Fox Chase Bladder Survey at Baseline and 3 Years | The Fox Chase Bowel/Bladder survey was divided into two sections: Bowel (questions 1 to 14, N=14) and Bladder (questions 19, and 21 to 30, N=11). To facilitate analysis, Bowel and Bladder scores for each section were rescaled to a total score of between 0 - 100, where higher scores indicated better Quality of Life. Results for the Bladder Section are reported here. | Baseline and 3 years |
| International Index of Erectile Function (IIEF) Score at Baseline and 3 Years | The IIEF is a 15-item survey where 9-items are scored 0-5 and 6-items are scored 1-5 with a total range of 6-75. The standard scoring mechanism was used for IIEF, where the QoL items corresponded to the following domains: erectile function (score range 1-30), orgasmic function (score range 1-10), sexual desire (score range 2-10), intercourse satisfaction (score range 0-15), and overall satisfaction (score range 2-10). Higher numbers indicate increased QoL. | Baseline and 3 years |
| Spritzer Quality of Life Index (SQLI) at Baseline and 3 Years | The SQLI is composed of five items (activity, daily living, health, support, outlook) scored utilizing a numerical scale of 0-2. Standard scoring was also used for the SQLI survey (total score range 0-10) where higher score indicate increased QoL. | Baseline and 3 years |
| BG002 | Level III | 4.3 gy/fr, 12 fractions, Radiotherapy: Daily radiation to prescribed dose |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Level 2 | 3.63 gy/fr, 16 fractions, Radiotherapy: Daily radiation to prescribed dose |
| OG002 | Level 3 | 4.3 gy/fr, 12 fractions, Radiotherapy: Daily radiation to prescribed dose |
|
|
| Primary | Number of Subjects Experiencing Grade 2 or Higher Late Rectal Toxicities at Any Time During Follow Up | To evaluate late radiation toxicities to dose-per fraction escalation in the treatment of prostate | Posted | Count of Participants | Participants | from 90 days post XRT through last follow-up visit (up to 3 years) |
|
|
|
| Secondary | Biochemical Progression-free Survival Based on PSA Surveillance | Patients will be considered to be without biochemical recurrence if either the Prostate-specific antigen (PSA) is still declining or the PSA nadir has been reached and is below 1.0ng/ml | Posted | Number | 95% Confidence Interval | percentage of participants | up to 15 years from enrollment |
|
|
|
| Secondary | Fox Chase Bowel Survey at Baseline and 3 Years | The Fox Chase Bowel/Bladder survey was divided into two sections: Bowel (questions 1 to 14, N=14) and Bladder (questions 19, and 21 to 30, N=11). To facilitate analysis, Bowel and Bladder scores for each section were rescaled to a total score of between 0 - 100, where higher scores indicated better Quality of Life (QoL). Results for the Bowel Section are reported here. | Unavailable quality of life questionnaires at year 3. All mean scores were adjusted for missing data. The missing data for questionnaires were handled by weighted mean imputation. Cases with more than half of the total questions missing were not included. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 3 years |
|
|
|
| Secondary | Fox Chase Bladder Survey at Baseline and 3 Years | The Fox Chase Bowel/Bladder survey was divided into two sections: Bowel (questions 1 to 14, N=14) and Bladder (questions 19, and 21 to 30, N=11). To facilitate analysis, Bowel and Bladder scores for each section were rescaled to a total score of between 0 - 100, where higher scores indicated better Quality of Life. Results for the Bladder Section are reported here. | Unavailable quality of life questionnaires at year 3. All mean scores were adjusted for missing data. The missing data for questionnaires were handled by weighted mean imputation. Cases with more than half of the total questions missing were not included. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 3 years |
|
|
|
| Secondary | International Index of Erectile Function (IIEF) Score at Baseline and 3 Years | The IIEF is a 15-item survey where 9-items are scored 0-5 and 6-items are scored 1-5 with a total range of 6-75. The standard scoring mechanism was used for IIEF, where the QoL items corresponded to the following domains: erectile function (score range 1-30), orgasmic function (score range 1-10), sexual desire (score range 2-10), intercourse satisfaction (score range 0-15), and overall satisfaction (score range 2-10). Higher numbers indicate increased QoL. | Unavailable quality of life questionnaires at year 3. All mean scores were adjusted for missing data. The missing data for questionnaires were handled by weighted mean imputation. Cases with more than half of the total questions missing were not included. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 3 years |
|
|
|
| Secondary | Spritzer Quality of Life Index (SQLI) at Baseline and 3 Years | The SQLI is composed of five items (activity, daily living, health, support, outlook) scored utilizing a numerical scale of 0-2. Standard scoring was also used for the SQLI survey (total score range 0-10) where higher score indicate increased QoL. | Unavailable quality of life questionnaires at year 3. All mean scores were adjusted for missing data. The missing data for questionnaires were handled by weighted mean imputation. Cases with more than half of the total questions missing were not included. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 3 years |
|
|
|
| 22 |
| 101 |
| 0 |
| 101 |
| 40 |
| 101 |
| EG001 | Level 2 | 3.63 gy/fr, 16 fractions, minimum 50 patients ( back filling permitted while next dose level data matures for escalation) first 10 treated with 4 fractions per week next 40 + treated with 5 fractions per week Radiotherapy: Daily radiation to prescribed dose | 18 | 111 | 0 | 111 | 56 | 111 |
| EG002 | Level 3 | 4.3 gy/fr, 12 fractions, 50 patients, for safety, up to an additional 100 for phase II component of study first 10 treated with 4 fractions per week next 40 +treated with 5 fractions per week Radiotherapy: Daily radiation to prescribed dose | 20 | 135 | 0 | 135 | 52 | 135 |
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| Acute GU | Renal and urinary disorders | Systematic Assessment | RTOG modified grading criteria |
|
| Late GI and GU toxicities | Renal and urinary disorders | Systematic Assessment | FC-LENT grading criteria |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Year 3 |
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| 3 years |
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| 3 years |
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| Year 3 |
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