Last updated on May 2019

Hypofractionated Proton Beam Therapy for Localized Prostate Cancer


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT01950351

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M D Anderson Cancer Center

Houston, TX United States
4.11miles
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Recruitment Status: Open


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