Clinical Trials /

Hypofractionated Proton Beam Therapy for Localized Prostate Cancer

NCT01950351

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Hypofractionated Proton Beam Therapy for Localized Prostate Cancer
  • Official Title: Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma

Clinical Trial IDs

  • ORG STUDY ID: 2012-1003
  • SECONDARY ID: NCI-2013-02347
  • NCT ID: NCT01950351

Conditions

  • Prostate Cancer

Purpose

The goal of this clinical research study is to learn if delivering proton therapy in higher doses per treatment may help control prostate cancer just as well as the standard of care treatment. The safety of this treatment will also be studied. Radiation dose is measured in units called Gray (Gy). The standard of care treatment schedule for proton therapy is 1.8-2 Gy, given 1 time per day, 5 days per week over a period of 8-9 weeks.

Detailed Description

      Proton Therapy:

      If you are eligible and agree to take part in this study, proton beam treatments will be
      delivered 2-3 days per week until you have received a total of 15 treatments.

      You will receive proton beam therapy to the prostate. Your doctor will place 2-3 small
      tissue markers (about the size of grain of rice) into your prostate to help guide the proton
      therapy. Anesthesia is not needed for this procedure. For each treatment, you will lie on a
      treatment table for about 20-30 minutes.

      Study Visits:

      During proton therapy you will talk with your doctor about how you are feeling 1 time every
      week.

      During your last week of proton therapy you will complete the questionnaire.

      For the first 24 months after proton therapy every 6-12 months, blood (about 2 tablespoons)
      will be drawn to check your PSA levels and you will complete the questionnaire. How often
      these visits occur will be up to the study doctor.

      At 36, 48, and 60 months after proton therapy, blood (about 2 tablespoons) will be drawn to
      check your PSA levels and you will be asked to complete the questionnaire.

      After proton beam therapy ends, if the study doctor thinks it is needed, you will have a
      digital rectal exam, an MRI, a bone scan, and/or a standard prostate biopsy to check the
      status of the disease.

      Length of Study:

      You will no longer be able to take part in this study if the disease gets worse, if
      intolerable side effects occur, or if you are unable to follow study directions.

      Your participation in this study will end 60 months after you complete proton therapy. Your
      doctor will continue to provide all necessary medical care after your participation has
      ended.

      This is an investigational study. Proton beam therapy is delivered using an FDA approved and
      commercially available method. The alternative schedules of proton beam therapy are
      investigational.

      Up to 150 participants will be enrolled in this study. All will take part at MD Anderson.
    

Trial Arms

NameTypeDescriptionInterventions
Proton Beam TherapyExperimentalThe total dose will be 55.5 Gy (RBE) delivered in 15 fractions of 3.7 Gy (RBE) to the prostate. Each fraction will be scheduled once daily allowing at least one day between treated fractions. Symptom questionnaire completed at baseline, during the last weeks of proton therapy, 6 months, 36 months, 48 months, and 60 months after therapy.

    Eligibility Criteria

            Inclusion Criteria:
    
              1. 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.
    
              2. History/physical examination with digital rectal examination of the prostate within
                 90 days prior to registration
    
              3. 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.
    
              4. Clinical stage T1-2b (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.
    
              5. Zubrod Performance Status 0-1 within 90 days prior to registration
    
              6. Age greater than or equal to 18 years
    
              7. Patient must be able to provide study-specific informed consent prior to study entry.
    
              8. Willingness and ability to complete the EPIC questionnaire
    
            Exclusion Criteria:
    
              1. Prior or concurrent invasive malignancy (except non-melanomatous skin cancer or
                 lymphomatous/hematogenous malignancy) unless continually disease free for a minimum
                 of 5 years
    
              2. Evidence of distant metastases
    
              3. Regional lymph node involvement
    
              4. Previous prostatectomy, cryosurgery, or HIFU for prostate cancer
    
              5. Previous pelvic radiation or prostate brachytherapy
    
              6. 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.)
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Incidence of Grade 2 Gastrointestinal Toxicity
    Time Frame:2 years
    Safety Issue:
    Description:Primary endpoint is the incidence of late grade 2 or greater gastrointestinal toxicity (GI). Methods used described by Gooley et al. (1999) to estimate the cumulative incidence of late grade 2 or greater GI toxicity, considering death from any cause as a competing event, and cumulative incidence estimated at 2 years with a 95% confidence interval.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:M.D. Anderson Cancer Center

    Trial Keywords

    • Prostate Cancer
    • Localized prostate cancer
    • Adenocarcinoma of the prostate
    • Proton therapy
    • Radiation therapy
    • XRT
    • Gray
    • Gy
    • Questionnaire
    • Survey

    Last Updated

    October 31, 2016