Hypofractionation Proton Beam Therapy With Concurrent Treatment of Prostate and Pelvic Nodes for Prostate Cancer

NCT02874014 | Completed Phase 2 Results DMC

• 3 other identifiers: MC165115-009528NCI-2017-02364
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Late Grade ≥ 2 GI and GU Toxicity of Interest, Using the CTCAE v4.0

  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

  Within 3 months post proton beam therapy

• Disease-free Survival Including Freedom From PSA Relapse at 5 Years Post Proton Beam Therapy

  5 years post proton beam therapy

• Disease-specific Survival at 5 Years Post Proton Beam Therapy

  5 years post proton beam therapy

Study Arms (1)

Hypofractionation Proton beam therapy

EXPERIMENTAL

Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes

Radiation: Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes

Interventions

Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes RADIATION

Hypofractionation Proton beam therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male; Age ≥ 18 years.
• 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.

You may not qualify if:

• Any known nodal (N1) or distant metastasis (M1)
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• 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.

  PMID: 39672515 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.

  PMID: 36427645 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.

  PMID: 34722810 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. C. Richard Choo
• Organization: Mayo Clinic

Choo.C@mayo.edu

507-284-3261

Study Officials

• Mark R. Waddle, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 22, 2016
• Study Start: July 25, 2016
• Primary Completion: February 8, 2021
• Study Completion: April 30, 2025
• Last Updated: August 22, 2025
• Results First Posted: July 10, 2023

Record last verified: 2025-07

Locations

US (2)