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| ID | Type | Description | Link |
|---|---|---|---|
| MC1651 | Other Identifier | Mayo Clinic | |
| 15-009528 | Other Identifier | Mayo Clinic Institutional Review Board | |
| NCI-2017-02364 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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The study is to examine a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The prostate and seminal vesicles are treated with 6750 centigray (RBE) in 25 fractions (i.e. 270 centigray/fraction), while the regional pelvic nodes receive 4500 centigray (RBE) in 25 fractions (i.e. 180 centigray/fraction) simultaneously. The overall treatment time is 5 weeks.
Proton beam therapy can provide a therapeutic gain by offering at least equivalent (or superior) tumor control while reducing the risk of radiation toxicity, in comparison with conventional photon-based external beam radiotherapy, given its dose-deposition characteristics. Currently the clinical target volume of proton beam for the treatment of prostate cancer has been mostly limited to the prostate and the seminal vesicles. There has been no study of proton beam therapy to treat both the primary tumor in the prostate and the regional pelvic nodes simultaneously using a moderate hypofractionation regimen.
The study is a prospective, single-arm, clinical trial to evaluate a moderate hypofractionation regimen of proton beam therapy for high risk or unfavorable intermediate risk prostate cancer. The clinical target volumes of proton beam therapy include both the prostate/seminal vesicles and the regional pelvic nodes. The primary objective is to assess late grade ≥ 3 gastrointestinal (GI) and genitourinary (GU) toxicity. The secondary objectives are to evaluate late grade ≥ 2 GI and GU toxicity, acute grade ≥ 3 GI and GU toxicity, and disease-free survival including freedom from PSA (prostate specific antigen) relapse at 5 years. The study provides an avenue to examine the safety, efficacy, cost effectiveness, and convenience of a moderate hypofractionation regimen (5-week course) of proton beam therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionation Proton beam therapy | Experimental | Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late Grade ≥ 3 Gastrointestinal (GI) and Genitourinary (GU) Toxicity of Interest, Using the CTCAE v4.0 | Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. A late GI or GU toxicity will be defined as a GI or GU toxicity that occurs between 3 months and 2 years from the completion of proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation. | Between 3 months and 24 months post proton beam therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Late Grade ≥ 2 GI and GU Toxicity of Interest, Using the CTCAE v4.0 | Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. A late GI or GU toxicity will be defined as a GI or GU toxicity that occurs between 3 months and 2 years from the completion of proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark R. Waddle, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Rochester |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41419026 | Derived | Mastroleo F, Borras-Osorio M, Patel SP, Peterson S, Wilson R, Zhou M, Shiraishi S, Foong AYK, Routman DM, Waddle MR. Large language models for toxicity extraction in oncology trials: A real-world benchmark in prostate radiotherapy. Radiother Oncol. 2026 Mar;216:111348. doi: 10.1016/j.radonc.2025.111348. Epub 2025 Dec 17. | |
| 39672515 |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypofractionation Proton Beam Therapy | Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes>>> >>>> >>> >>>> Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Oct 24, 2019 |
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| Between 3 months and 24 months post proton beam therapy |
| Acute Grade ≥ 3 GI and GU Toxicity of Interest Within 3 Months Post Proton Beam Therapy, Using the CTCAE v4.0 | Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation | Within 3 months post proton beam therapy |
| Disease-free Survival Including Freedom From PSA Relapse at 5 Years Post Proton Beam Therapy | Disease-free survival is defined as the time from registration until the time of the first occurrence of biochemical failure, local recurrence, regional recurrence, distant metastases, or death due to any cause. The distribution of disease-free survival will be estimated using the method of Kaplan-Meier. | 5 years post proton beam therapy |
| Disease-specific Survival at 5 Years Post Proton Beam Therapy | Disease-free survival is defined as the time from registration until the time of the first occurrence of biochemical failure, local recurrence, regional recurrence, distant metastases, or death due to any cause. The distribution of disease-free survival will be estimated using the method of Kaplan-Meier. | 5 years post proton beam therapy |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Choo R, Hillman DW, Mitchell C, Daniels T, Vargas C, Rwigema JC, Corbin K, Keole S, Vora S, Merrell K, Stish B, Pisansky TM, Davis BJ, Amundson A, Wong W. Five-Year Outcomes of Moderately Hypofractionated Proton Therapy Incorporating Elective Pelvic Nodal Irradiation for High-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2025 May 1;122(1):99-108. doi: 10.1016/j.ijrobp.2024.11.115. Epub 2024 Dec 11. |
| 36427645 | Derived | Choo R, Hillman DW, Mitchell C, Daniels T, Vargas C, Rwigema JC, Corbin K, Keole S, Vora S, Merrell K, Stish B, Pisansky T, Davis BJ, Amundson A, Wong W. Late Toxicity of Moderately Hypofractionated Intensity-Modulated Proton Therapy Treating the Prostate and Pelvic Lymph Nodes for High-Risk Prostate Cancer. Int J Radiat Oncol Biol Phys. 2023 Apr 1;115(5):1085-1094. doi: 10.1016/j.ijrobp.2022.11.027. Epub 2022 Nov 22. |
| 34722810 | Derived | Choo R, Hillman DW, Daniels T, Vargas C, Rwigema JC, Corbin K, Keole S, Vora S, Merrell K, Stish B, Pisansky T, Davis B, Amundson A, Wong W. Proton Therapy of Prostate and Pelvic Lymph Nodes for High Risk Prostate Cancer: Acute Toxicity. Int J Part Ther. 2021 Sep 14;8(2):41-50. doi: 10.14338/IJPT-20-00094.1. eCollection 2021 Fall. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypofractionation Proton Beam Therapy | Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes>>>> >>>> Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Performance status (ECOG) | 0: Asymptomatic and fully active.>>> 1: Symptomatic; fully ambulatory; restricted in physically strenuous activity.>>> ECOG = 0 is better. ECOG = 1 is worse. | Count of Participants | Participants |
| |||||||||||||||||
| BMI | Median | Full Range | kg/m^2 |
| |||||||||||||||||
| Prostate volume (mL) | Median | Inter-Quartile Range | mL |
| |||||||||||||||||
| History of prior TURP | Count of Participants | Participants |
| ||||||||||||||||||
| Use of alpha-1 blocker | Count of Participants | Participants |
| ||||||||||||||||||
| Use of antiplatelet or anticoagulant medication | Count of Participants | Participants |
| ||||||||||||||||||
| Baseline IPSS score | A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms | Two patients are missing scores | Count of Participants | Participants |
| ||||||||||||||||
| Gleason score | The Gleason score usually ranges from 6 to 10. The lower the Gleason score, the more the cancer cells look like normal cells and are likely to grow and spread slowly. | Count of Participants | Participants |
| |||||||||||||||||
| Baseline PSA, ng/mL | Median | Full Range | ng/mL |
| |||||||||||||||||
| T stage | T1 means the cancer is too small to be seen on a scan, or felt during an examination of the prostate. T2 means the cancer is completely inside the prostate gland. T3a means the cancer has broken through the capsule (covering) of the prostate gland. T3b means the cancer has spread into the tubes that carry semen (seminal vesicles). T4 means the cancer has spread into other body organs nearby, such as the back passage, bladder, or the pelvic wall. | Count of Participants | Participants |
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| Risk | Count of Participants | Participants |
| ||||||||||||||||||
| Duration of ADT (mo) | Median | Full Range | months |
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| 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 | Late Grade ≥ 3 Gastrointestinal (GI) and Genitourinary (GU) Toxicity of Interest, Using the CTCAE v4.0 | Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. A late GI or GU toxicity will be defined as a GI or GU toxicity that occurs between 3 months and 2 years from the completion of proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation. | Posted | Count of Participants | Participants | Between 3 months and 24 months post proton beam therapy |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Late Grade ≥ 2 GI and GU Toxicity of Interest, Using the CTCAE v4.0 | Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. A late GI or GU toxicity will be defined as a GI or GU toxicity that occurs between 3 months and 2 years from the completion of proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation | Posted | Count of Participants | Participants | Between 3 months and 24 months post proton beam therapy |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Acute Grade ≥ 3 GI and GU Toxicity of Interest Within 3 Months Post Proton Beam Therapy, Using the CTCAE v4.0 | Toxicity will be defined as an adverse event possibly, probably, or definitely related to proton beam therapy. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for late toxicity, with the exception of patients determined to be a major violation | Posted | Count of Participants | Participants | Within 3 months post proton beam therapy |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Disease-free Survival Including Freedom From PSA Relapse at 5 Years Post Proton Beam Therapy | Disease-free survival is defined as the time from registration until the time of the first occurrence of biochemical failure, local recurrence, regional recurrence, distant metastases, or death due to any cause. The distribution of disease-free survival will be estimated using the method of Kaplan-Meier. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post proton beam therapy |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Disease-specific Survival at 5 Years Post Proton Beam Therapy | Disease-free survival is defined as the time from registration until the time of the first occurrence of biochemical failure, local recurrence, regional recurrence, distant metastases, or death due to any cause. The distribution of disease-free survival will be estimated using the method of Kaplan-Meier. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years post proton beam therapy |
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|
5 years post proton beam therapy
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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 | Hypofractionation Proton Beam Therapy | Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes | 0 | 55 | 0 | 55 | 55 | 55 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
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| Fecal incontinence | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
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| Proctitis | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
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| Rectal stenosis | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
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| Rectal ulcer | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | CTCAE 4 | Systematic Assessment |
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| Bladder spasm | Renal and urinary disorders | CTCAE 4 | Systematic Assessment |
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| Cystitis noninfective | Renal and urinary disorders | CTCAE 4 | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | CTCAE 4 | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | CTCAE 4 | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | CTCAE 4 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTCAE 4 | Systematic Assessment |
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| Urinary tract obstruction | Renal and urinary disorders | CTCAE 4 | Systematic Assessment |
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| Urinary tract pain | Renal and urinary disorders | CTCAE 4 | Systematic Assessment |
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| Urinary urgency | Renal and urinary disorders | CTCAE 4 | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | CTCAE 4 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. C. Richard Choo | Mayo Clinic | 507-284-3261 | Choo.C@mayo.edu |
| Mar 16, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 13, 2018 | Jul 7, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| ECOG score 1 |
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| 8-19 |
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| 20-35 |
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| 7 |
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| 8-10 |
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| T3a |
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| T3b |
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| T4 |
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