Hypofractionated Proton Beam Therapy for Localized Prostate Cancer

NCT ID: NCT01950351

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-10
• Study Completion Date: 2028-06-01

Brief Summary

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.

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.

Conditions

Stage I Prostate Adenocarcinoma AJCC v7; Stage II Prostate Adenocarcinoma AJCC v7

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (proton beam radiation therapy)

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

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Proton Beam Radiation Therapy

Intervention Type: RADIATION

Undergo proton beam radiation therapy

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Interventions

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Proton Beam Radiation Therapy

Undergo proton beam radiation therapy

Intervention Type: RADIATION

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

PBRT; Proton Radiation Therapy; Quality of Life Assessment

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven J Frank

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

NCI-2013-02347

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-1003

Identifier Type: OTHER

Identifier Source: secondary_id

2012-1003

Identifier Type: -

Identifier Source: org_study_id