Prostate CancerPhase 2NCT02874014

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

A Phase 2 study testing Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes in people with Prostate Cancer, run by Mayo Clinic at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 2 sitesUnited States
Study dates: 25 Jul 2016to 30 Apr 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Show all 9Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: Prospective Evaluation of Hypofractionation Proton Beam Therapy With Concurrent Treatment of the Prostate and Pelvic Nodes for Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer

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.

Read the detailed description

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.

Conditions: Prostate Cancer
Being tested: Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02874014
Study group	Role	What they receive
Hypofractionation Proton beam therapy	Experimental	Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes Receives: Radiation: Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 5 years post proton beam therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jul 201630 Apr 2025

First posted22 Aug 2016 (estimated)
Study start25 Jul 2016
Primary completion8 Feb 2021
Study completion30 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02874014
Sponsor's protocol ID: MC1651
Other IDs: MC1651, 15-009528, NCI-2017-02364
Status last verified: Jul 2025
First submitted: 17 Aug 2016
Last updated: 22 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 41419026
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.
PubMed 39672515
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.
PubMed 36427645
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.
PubMed 34722810

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Evaluation of Hypofractionation Proton Beam Therapy With Concurrent Treatment of the Prostate and Pelvic Nodes for Clinically Localized, High Risk or Unfavorable Intermediate Risk Prostate Cancer
ClinicalTrials.gov ID: NCT02874014
Acronym / sponsor ID: MC1651
Conditions: Prostate Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 25 Jul 2016 (actual)
Primary completion: 8 Feb 2021 (actual)
Study completion: 30 Apr 2025 (actual)
First posted: 22 Aug 2016 (estimated)
Results: Posted 10 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Hypofractionation Proton beam therapy	Experimental	Radiation: Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic NodesHypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes	Radiation	Hypofractionation Proton beam therapy

Primary outcome

Late Grade ≥ 3 Gastrointestinal (GI) and Genitourinary (GU) Toxicity of Interest, Using the CTCAE v4.0
Time frame: Between 3 months and 24 months post proton beam therapy
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.

4 secondary outcomes

Late Grade ≥ 2 GI and GU Toxicity of Interest, Using the CTCAE v4.0
Time frame: 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
Time frame: Within 3 months post proton beam therapy
Disease-free Survival Including Freedom From PSA Relapse at 5 Years Post Proton Beam Therapy
Time frame: 5 years post proton beam therapy
Disease-specific Survival at 5 Years Post Proton Beam Therapy
Time frame: 5 years post proton beam therapy

Results and safety

Results posted to the registry on 10 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hypofractionation Proton Beam Therapy	56	54

Primary outcome: Late Grade ≥ 3 Gastrointestinal (GI) and Genitourinary (GU) Toxicity of Interest, Using the CTCAE v4.0

Time frame: Between 3 months and 24 months post proton beam therapy. Count of participants. Unit: Participants

Measure	Hypofractionation Proton Beam Therapy n = 54
GI grade ≥ 3	1
GU grade ≥ 3	0

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years post proton beam therapy. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hypofractionation Proton Beam Therapy	0 of 55 (0%)	55 of 55 (100%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41419026Mastroleo 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.
Derived from this study: PubMed 39672515Choo 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.
Derived from this study: PubMed 36427645Choo 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.
Derived from this study: PubMed 34722810Choo 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.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark R. Waddle, MD principal investigator

Mayo Clinic

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late Grade ≥ 3 Gastrointestinal (GI) and Genitourinary (GU) Toxicity of Interest, Using the CTCAE v4.0 (time frame: Between 3 months and 24 months post proton beam therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02874014, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.