Study on Hypofractionated Proton Beam Therapy for Localized Prostate Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT01950351

Provider View

This clinical trial is exploring the use of a specialized radiation therapy called hypofractionated proton beam therapy to treat prostate cancer that hasn't spread beyond the prostate. The study aims to see if this treatment can effectively target the tumor while minimizing damage to surrounding healthy tissue.

Patient Parameters

Program Overview

This study is testing a type of radiation therapy called hypofractionated proton beam therapy for treating prostate cancer that hasn't spread to lymph nodes or other parts of the body. Proton beam therapy is a precise form of radiation that aims to deliver high doses directly to the tumor, potentially killing more cancer cells and causing less harm to normal tissues. The trial will assess the side effects and effectiveness of this treatment over time.

Description

The main goal of this study is to find out how often patients experience moderate gastrointestinal side effects two years after receiving hypofractionated proton beam therapy.

Other goals include:

  • Evaluating changes in patients' quality of life after treatment compared to before treatment, using specific questionnaires.
  • Measuring the rates of immediate and long-term side effects from the treatment.
  • Checking the effectiveness of the therapy by monitoring prostate-specific antigen (PSA) levels over five years.
  • Determining the rate of cancer recurrence in the prostate through biopsy if tests suggest a relapse.

Participants will receive proton beam radiation therapy in 15 sessions over 5 to 6 weeks. After completing the treatment, they will have follow-up visits every 6 to 12 months for two years, and then annually until five years after treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate adenocarcinoma within the past year, confirmed by lab tests.
  • Underwent a physical exam, including a digital rectal exam, within 90 days before joining the study.
  • Prostate biopsy results with a Gleason score between 2 and 7, obtained within a year before joining.
  • Clinical stage T1-2b prostate cancer with a PSA level under 20 ng/mL, measured within 90 days before joining.
  • Good overall health with a performance status score of 0 or 1.
  • Able to provide informed consent and willing to complete a quality of life questionnaire.

Exclusion Criteria

  • Have had another invasive cancer within the past five years, except for certain skin cancers.
  • Cancer has spread to distant parts of the body or nearby lymph nodes.
  • Have had previous prostate surgery or certain prostate treatments like cryosurgery or HIFU.
  • Have had previous radiation therapy to the pelvis or prostate.
  • Have severe medical conditions such as recent heart problems, active infections, severe lung disease, liver issues, inflammatory bowel disease, connective tissue disorders, or blood clotting disorders.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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