Clinical Trials /

Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer

NCT01617161

Description:

We are studying whether men being treated for prostate cancer have the same amount of side effects from either one of two different external radiation treatments: IMRT or PBT. With IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is another type of external radiation treatment for prostate cancer that is used in a few centers in the United States. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop. PBT is precise like IMRT, but it uses proton beams instead of x-ray beams. IMRT and PBT aim to deliver most of the radiation to the prostate cancer while sparing surrounding tissues. Both IMRT and PBT have been used in the treatment of prostate cancer and are thought to be equally effective at curing prostate cancer. However, both treatments have also been shown to cause the potential side effects of radiation, including bowel, urinary and erectile problems. It is possible that side effect rates with PBT will be lower, the same, or even higher than with IMRT, but this has not been studied well to date. Though both of these radiation therapies have been used in the past to treat prostate cancer, there has never been a study that compares the effects of these two therapies to see which one has less side effects. In this research study, we are comparing IMRT to PBT to determine which therapy best minimizes the side effects of treatment.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer
  • Official Title: Prostate Advanced Radiation Technologies Investigating Quality of Life (PARTIQoL): A Phase III Randomized Clinical Trial of Proton Therapy vs IMRT for Low or Intermediate Risk Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 11-497
  • NCT ID: NCT01617161

Conditions

  • Prostate Cancer

Purpose

We are studying whether men being treated for prostate cancer have the same amount of side effects from either one of two different external radiation treatments: IMRT or PBT. With IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is another type of external radiation treatment for prostate cancer that is used in a few centers in the United States. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop. PBT is precise like IMRT, but it uses proton beams instead of x-ray beams. IMRT and PBT aim to deliver most of the radiation to the prostate cancer while sparing surrounding tissues. Both IMRT and PBT have been used in the treatment of prostate cancer and are thought to be equally effective at curing prostate cancer. However, both treatments have also been shown to cause the potential side effects of radiation, including bowel, urinary and erectile problems. It is possible that side effect rates with PBT will be lower, the same, or even higher than with IMRT, but this has not been studied well to date. Though both of these radiation therapies have been used in the past to treat prostate cancer, there has never been a study that compares the effects of these two therapies to see which one has less side effects. In this research study, we are comparing IMRT to PBT to determine which therapy best minimizes the side effects of treatment.

Detailed Description

      Because no one knows which of the study options is best, you will be "randomized" into one of
      the study groups: IMRT or PBT. Randomization means that you are put into a group by chance,
      like flipping a coin. Neither you nor the research doctor will choose which group you will be
      in. You will have an equal chance of being placed in either group. Randomization makes the
      study better from a scientific point of view because it helps ensure that patients receiving
      IMRT and proton therapy are similar. You will be receiving only one type of radiation, either
      IMRT or PBT throughout your participation in the study.

      Before you begin radiation therapy you will have a pelvic CT scan in order to design your
      radiation treatment. Doctors will use information gathered from these scans to plan the best
      way to deliver radiation to your tumor.

      Both types of radiation therapy will be given once a day for 5 days (no weekends or holidays)
      for up to 9 weeks. Both IMRT and PBT will require that you lie on a table for less than 15
      minutes to obtain your treatment.

      During each visit you will be asked questions about your general health and specific
      questions about any problems that you might be having and any medications you might be
      taking. You will also undergo a physical exam and complete some quality of life
      questionnaires.

      After your radiation therapy you will have follow up visits at 3,6,9,12,18,24,36,48 and 60
      months.
    

Trial Arms

NameTypeDescriptionInterventions
PBTActive ComparatorProton Beam Therapy
    IMRTActive ComparatorIntensity Modulated Radiation Therapy

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Diagnosed with histologically confirmed adenocarcinoma of the prostate based on
                   core-biopsy within 1 year of study entry from TRUS
      
                -  Clinical stages T1c to T2c
      
                -  PSA <20, within 6 months of study entry
      
                -  Participants who are currently receiving Dutasteride (or have received it within the
                   last 90 days) or Finasteride (or have received it within the last 30 days) must have a
                   PSA of ≤ 10
      
                -  Gleason score ≤6, 3 + 4 = 7, or 4 + 3 = 7
      
                -  ECOG Performance Status 0-1 as documented within 3 months prior to study entry
      
                -  Must have complete history and physical examination within 45 days of study entry and
                   digital rectal examination of prostate within 180 days of study entry
      
              Exclusion Criteria:
      
                -  Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy
                   or radiation for PCa
      
                -  Prior or planned androgen deprivation or bilateral orchiectomy
      
                -  Distant metastases, or clinically or pathologically involved lymph nodes confirmed by
                   a CT scan within 365 days of study entry
      
                -  Hip prosthesis, inflammatory bowel disease or connective tissue disorder such as
                   active scleroderma or lupus
      
                -  Individuals with a history of other malignancies are ineligible unless 1) they have
                   been disease-free for at least 5 years OR 2) are deemed by the investigator to be at
                   low risk for recurrence of that malignancy with no plans for adjuvant systemic
                   chemotherapy and/or radiation therapy and have received overall principal investigator
                   approval.
      
                -  Individuals who have AIDS (CD4 < 200 or an AIDS-defining illness) or are HIV positive
                   and not on HAART therapy are ineligible.
      
                -  Major medical or psychiatric illness
      
                -  Individuals with any of the following conditions are excluded from this study:
      
                     -  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
      
                     -  History of Hepatic insufficiency resulting in clinical jaundice and/or
                        coagulation defects within the last 12 months
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Efficacy of PBT vs. IMRT
      Time Frame:2 years
      Safety Issue:
      Description:Compare the reduction in mean EPIC bowel scores for men with low or low-intermediate risk PCa treated with PBT versus IMRT at 24 months following radiation (where higher scores represent better outcomes)

      Secondary Outcome Measures

      Measure:Disease Specific Quality of Life
      Time Frame:2 years
      Safety Issue:
      Description:Assess the effectiveness of PBT versus IMRT for men with low or low-intermediate risk PCa in terms of disease-specific quality of life as measured by patient-reported outcomes, perceptions of care and adverse events
      Measure:Cost Effectiveness of PBT vs. IMRT
      Time Frame:2 years
      Safety Issue:
      Description:Assess the cost-effectiveness of PBT versus IMRT under current conditions and model future cost-effectiveness for alternative treatment delivery and cost scenarios
      Measure:Radiation Dose and Bowel, Urinary and Erectile Function
      Time Frame:2 years
      Safety Issue:
      Description:Develop predictive models to examine the associations between selected metrics of individual radiation dose distributions and patient reported bowel, urinary and erectile function
      Measure:Identification and Evaluation Biomarkers of PCa Behavior
      Time Frame:2 years
      Safety Issue:
      Description:Identify and evaluate biomarkers of prostate cancer behavior and response to radiotherapy
      Measure:Long Term Survival
      Time Frame:10 years
      Safety Issue:
      Description:Assess longer-term rates of disease-specific and overall survival as well as development of late effects such as second cancers

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Massachusetts General Hospital

      Trial Keywords

      • Low Risk
      • Intermediate Risk

      Last Updated

      August 22, 2019