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

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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

Condition: Prostate Cancer

Intervention:

  • Radiation: Proton Beam Therapy
  • Radiation: Intensity Modulated Radiation Therapy

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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01617161

Sponsor: Massachusetts General Hospital

Primary Outcome Measures:

  • Measure: Efficacy of PBT vs. IMRT
  • Time Frame: 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Disease Specific Quality of Life
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Cost Effectiveness of PBT vs. IMRT
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Radiation Dose and Bowel, Urinary and Erectile Function
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Identification and Evaluation Biomarkers of PCa Behavior
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Long Term Survival
  • Time Frame: 10 years
  • Safety Issue:

Estimated Enrollment: 400

Study Start Date: July 2012

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

Locations:

  • University of Florida Health Proton Therapy Institute
  • Jacksonville Florida 32206 United States
  • Northwestern Medicine Chicago Proton Center
  • Chicago Illinois 60190 United States
  • University of Maryland Medical Center
  • College Park Maryland 20742 United States
  • Massachusetts General Hospital
  • Boston Massachusetts 02114 United States
  • Mass General/North Shore Cancer Center
  • Danvers Massachusetts 01923 United States
  • Mayo Clinic
  • Rochester Minnesota 55905 United States
  • Washington University
  • Saint Louis Missouri 63110 United States
  • Rutgers Cancer Institute of New Jersey
  • New Brunswick New Jersey 08903 United States
  • Princeton ProCure Proton Therapy Center
  • Somerset New Jersey 08873 United States
  • University Hospital of Cleveland
  • Cleveland Ohio 44106 United States
  • Hospital of the University of Pennsylvania
  • Philadelphia Pennsylvania 19104 United States
  • Provision Proton Therapy Center
  • Knoxville Tennessee 37909 United States
  • University of Washington Medical Center
  • Seattle Washington 98195 United States

View trial on ClinicalTrials.gov

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