Hypofractionated Proton Beam Therapy for Localized Prostate Cancer

Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma

This phase II trial studies the side effects and how well hypofractionated proton beam radiation therapy works in treating patients with prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

Study Overview

• Status: Active, not recruiting
• Conditions: Stage I Prostate Adenocarcinoma AJCC v7; Stage II Prostate Adenocarcinoma AJCC v7
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Radiation: Proton Beam Radiation Therapy

Detailed Description

PRIMARY OBJECTIVES:

I. Estimate the incidence of grade 2 gastrointestinal toxicity following the proposed treatment regimens at 2 years post-treatment.

SECONDARY OBJECTIVES:

I. Estimate the change in health related quality of life (HRQOL) following the proposed treatment regimen compared to pre-treatment assessment as defined by Expanded Prostate Cancer Index Composite (EPIC), Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire.

II. Estimate the rates of acute toxicity of the treatment regimens. III. Estimate the rates of late toxicity at 3, 4, and 5 years post-treatment. IV. Assess the efficacy of hypo-fractionated proton beam therapy, defined by the incidence of a rising prostate-specific antigen (PSA) at 5 years.

V. Determine the rate of local failure by biopsy of the prostate when objective tests, prostate-specific antigen (PSA), magnetic resonance imaging (MRI), digital rectal exam (DRE), suggest relapse.

OUTLINE:

Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.

After completion of study treatment, patients are followed up every 6-12 months for 24 months and then annually until month 60.

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed diagnosis of adenocarcinoma of the prostate within one year of study entry; evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson
• History/physical examination with digital rectal examination of the prostate within 90 days prior to registration
• Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material demonstrating Gleason score 2-7 within 365 days of registration
• Clinical stage T1-2b (American Joint Committee on Cancer [AJCC] 7th edition) and PSA < 20 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy
• Zubrod performance status 0-1 within 90 days prior to registration
• Patient must be able to provide study-specific informed consent prior to study entry
• Willingness and ability to complete the EPIC questionnaire

Exclusion Criteria:

• Prior or concurrent invasive malignancy (except non-melanomatous skin cancer or lymphomatous/hematogenous malignancy) unless continually disease free for a minimum of 5 years
• Evidence of distant metastases
• Regional lymph node involvement
• Previous prostatectomy, cryosurgery, or high intensity focused ultrasound (HIFU) for prostate cancer
• Previous pelvic radiation or prostate brachytherapy
• Active and severe medical co-morbidity defined as follows: unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months, transmural myocardial infarction within the last 6 months, acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration, hepatic insufficiency resulting in clinical jaundice, active inflammatory bowel disease (Crohn's disease or ulcerative colitis), diagnosed connective tissue disorder, or congenital coagulation defects (patients on medical therapy with Coumadin or other blood thinning agents are eligible for participation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (proton beam radiation therapy); Patients undergo proton beam radiation therapy in 15 fractions over 5-6 weeks.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Radiation: Proton Beam Radiation Therapy; Undergo proton beam radiation therapy; Other Names: Proton Radiation Therapy; PBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of late grade 2 or greater gastrointestinal (GI) toxicity	The cumulative incidence of late grade 2 or greater GI toxicity will be estimated with a 95% confidence interval.	Up to 2 years post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of acute toxicity	Rates of acute toxicity will be assessed.	Within 90 days of treatment initiation
Rate of late toxicity	Rate of late toxicity will be determined.	Up to 5 years post-treatment
Change in health related quality of life (HRQOL) as assessed by the Expanded Prostate Cancer Index Composite (EPIC) Utilization of Sexual Medications/Devices, and Medical history/conditions questionnaire	Change in HRQOL will be evaluated.	Baseline to up to 5 years
Incidence of rising prostate-specific antigen (PSA)	Incidence of rising PSA will be assessed.	At 5 years
Rate of local failure by biopsy	Rate of local failure by biopsy will be evaluated.	Up to 5 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Steven J Frank, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2013
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: September 23, 2013
• First Submitted That Met QC Criteria: September 23, 2013
• First Posted (Estimated): September 25, 2013

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Prostatic Neoplasms; Adenocarcinoma; Therapeutics; Physical Phenomena; Inorganic Chemicals; Elements; Ions; Electrolytes; Radiotherapy; Gases; Elementary Particles; Heavy Ion Radiotherapy; Cations, Monovalent; Cations; Hydrogen; Nucleons; Proton Therapy; Protons
• Other Study ID Numbers: 2012-1003 (Other Identifier: M D Anderson Cancer Center); NCI-2013-02347 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No