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| ID | Type | Description | Link |
|---|---|---|---|
| P01CA088960 | U.S. NIH Grant/Contract | View source | |
| H-2004-0472 | Other Identifier | Institutional Review Board | |
| NCI-2011-00947 | Registry Identifier | NCI Trial ID | |
| A533300 | Other Identifier | UW Madison | |
| SMPH\HUMAN ONCOLOGY | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to examine the clinical feasibility and efficacy of uing IMRT to escalate the biologically effective dose to the pelvic lymph nodes in a short course of radiation therapy. An increased total and biologically effective dose will be delivered to the pelvic lymph nodes (56 Gy at 2 Gy/fraction). The prostate will receive standard "short course" IMRT of radiation (70 Gy at 2.5 Gy/fraction).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | prostate radiation to 70Gy, lymph nodes to 56Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiotherapy | Radiation | prostate radiation to 70Gy; nodal radiation to 56Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Expected Toxicities | Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival | Clinically evaluate local tumor control and biochemical progression-free and metastasis-free survivals. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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All participants are assigned to the experimental arm.
This study enrolled patients with high-risk prostate adenocarcinoma or radiographic evidence of pelvic lymph node involvement but absence of distal metastases from the Midwest. The last patient completed in February 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants with histologically confirmed prostate cancer and no evidence of bone or extrapelvic metastases were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy |
| 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 | Number of Participants Experiencing Expected Toxicities | Tolerances to high dose RT to Pelvic Lymph nodes in treatment of prostate cancer; measured by participants experiencing expected toxicities. | Only 25 of 30 participants met the minimum follow up thresholds at the time of analysis; the 5 most recently accrued participants' data was not analyzed and is not reflected. | Posted | Count of Participants | Participants | Up to 5 years |
|
Participants were followed up 1 month upon completion, every 3 months for 1 year after treatment, every 4 months during Years 2 and 3, every 6 months during Years 4 and 5, and then annually, with median follow up time as 25.4 months (range, 4.2 - 57.2 months). Bone scans and CT during follow-ups were not routinely performed but were carried out in the context of rising PSA levels. Of 30 participants, only 25 met the minimum follow up thresholds at the time of analysis.
Toxicity grading is based on a modified RTOG acute/late toxicity grading criteria.
Serious adverse events are defined as all Grade 4 and Grade 5 toxicities. Acute toxicities are scored from the start of radiation to 90 days after completion of radiation. Late toxicities are scored > 90 days from the completion of radiation therapy for 5 years.
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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 | Experimental | Pelvic nodal and prostatic image-guided IMRT was delivered to high pelvic nodal risk participants to a nodal dose of 56 Gy in 2-Gy fractions with concomitant treatment of the prostate to 70 Gy in 28 fractions of 2.5 Gy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute GI Grade 1 | Gastrointestinal disorders | RTOG grading | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark A. Ritter | University of Wisconsin Carbone Cancer Center | 608-263-8500 | ritter@humonc.wisc.edu |
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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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| Participants |
|
| 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 |
|
| T stage | Participants with stage T1-T4 disease, as defined by 1997 AJCC classification, were enrolled. The T Stage information of the last 5 participants enrolled is not included. The T stages reported in this table are refer to the following stages: T1c: Tumor identified by needle biopsy (eg, because of elevated PSA) T2a: Tumor involves one lobe T2b,c: Tumor involves both lobes T3a,b: Tumor extends through the prostate capsule, extracapsular extension (unilateral or bilateral), and tumor invades seminal vesicle(s) T4: Tumor is fixed or invades adjacent structures other than seminal vesicles | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | To Evaluate Local Tumor Control and Biochemical Progression-free and Metastasis-free Survival | Clinically evaluate local tumor control and biochemical progression-free and metastasis-free survivals. | Data was not collected for this outcome measure. Results can not be reported or analyzed. | Posted | 5 years |
|
|
| 6 |
| 25 |
| 0 |
| 25 |
| 13 |
| 25 |
| Acute GI Grade 2 | Gastrointestinal disorders | RTOG grading | Systematic Assessment |
|
| Late GI Grade 1 | Gastrointestinal disorders | RTOG grading | Systematic Assessment |
|
| Late GI Grade 2 | Gastrointestinal disorders | RTOG grading | Systematic Assessment |
|
| Acute GU Grade 1 | Renal and urinary disorders | RTOG grading | Systematic Assessment |
|
| Acute GU Grade 2 | Renal and urinary disorders | RTOG grading | Systematic Assessment |
|
| Late GU Grade 1 | Renal and urinary disorders | RTOG grading | Systematic Assessment |
|
| Late GU Grade 2 | Renal and urinary disorders | RTOG grading | Systematic Assessment |
|
| Late GU Grade 3 | Renal and urinary disorders | RTOG grading | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |