Hypofractionation Proton Beam Therapy With Concurrent Treatment of Prostate and Pelvic Nodes for Prostate Cancer
NCT ID: NCT02874014
Last Updated: 2025-08-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2016-07-25
2025-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Interventions
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Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
Eligibility Criteria
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Inclusion Criteria
* Histological confirmation of adenocarcinoma of the prostate within 6 months of study enrollment.
* Clinical stage T1-2 N0 M0, Gleason Score 7, Prostate Specific Antigen (PSA) 20-100 ng/mL, or Clinical stage Any T N0 M0, Gleason Score 8-10, PSA ≤ 100 ng/mL, or Clinical stage T3-4 N0 M0, any Gleason Score, PSA ≤ 100 ng/mL, or Clinical stage T1-2 N0 M0, Gleason Score 4+3, PSA 10-20 ng/mL
* Zubrod performance score (PS) ≤ 1
* Total bilirubin, aspartate aminotransferase, alkaline phosphatase, and serum creatinine: \< 2 x upper normal limit
* Signed informed consent.
Exclusion Criteria
* Previous androgen deprivation therapy lasting more than 6 months
* History of inflammatory bowel disease
* Presence of a hip prosthesis
* Prior pelvic radiotherapy or prostatectomy
* Prior or concurrent antineoplastic agents (chemotherapy)
* Previous or concurrent malignancy other than non-melanoma skin cancer within 5 years of diagnosis of prostate cancer.
* Inability to start the protocol treatment within 1 month after study enrollment.
* Medical or psychiatric conditions that preclude informed decision-making or compliance with the protocol treatment or follow-up
18 Years
MALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Mark R. Waddle, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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MC1651
Identifier Type: OTHER
Identifier Source: secondary_id
15-009528
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2017-02364
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC1651
Identifier Type: -
Identifier Source: org_study_id
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