Clinical Trial - NCT01617161

       

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

Recruiting

Sponsor: Massachusetts General Hospital

Collaborators: University of Pennsylvania, National Cancer Institute (NCI), Northwestern Medicine Chicago Proton Center, ProCure Proton Therapy Center, Washington University School of Medicine, University of Washington, Rutgers Cancer Institute of New Jersey, Provision Center for Proton Therapy, Mayo Clinic, University of Maryland, College Park, University Hospitals Cleveland Medical Center, University of Florida Proton Therapy Institute

Information provided by (Responsible party): Principal Investigator Massachusetts General Hospital Jason Efstathiou Principal Investigator

ClinicalTrials.gov Identifier: NCT01617161

Protocol Info

Short Description: Phase III Proton Therapy vs IMRT for Low or Low-intermediate Risk Prostate Cancer
Long Description: Phase III Randomized Clinical Trial of Proton Therapy vs IMRT for Low or Low-intermediate Risk Prostate Cancer
MGH Status: Open
Sponsor: DF/HCC
Disease Program: Proton

Next Steps


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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.
Condition Title Intervention Phase
Prostate Cancer Proton Beam Therapy Intensity Modulated Radiation Therapy N/A
Study Type Interventional
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

Primary Outcome Measures

Efficacy of PBT vs. IMRT [Time Frame: 2 years] [Designated as safety issue: ]


Secondary Outcome Measures

Disease Specific Quality of Life [Time Frame: 2 years] [Designated as safety issue: ]

Cost Effectiveness of PBT vs. IMRT [Time Frame: 2 years] [Designated as safety issue: ]

Radiation Dose and Bowel, Urinary and Erectile Function [Time Frame: 2 years] [Designated as safety issue: ]

Identification and Evaluation Biomarkers of PCa Behavior [Time Frame: 2 years] [Designated as safety issue: ]

Long Term Survival [Time Frame: 10 years] [Designated as safety issue: ]

Estimated Enrollment: 400
Study Start Date: July 2012
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2021
Arms Assigned Interventions

Active Comparator:PBT

Proton Beam Therapy
Radiation:Proton Beam Therapy
5 days per week up to 9 weeks

Active Comparator:IMRT

Intensity Modulated Radiation Therapy
Radiation:Intensity Modulated Radiation Therapy
5 times per week up to 9 weeks

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: Male

Accepts Healthly Volunteers: No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617161

Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

University of Pennsylvania

National Cancer Institute (NCI)

Northwestern Medicine Chicago Proton Center

ProCure Proton Therapy Center

Washington University School of Medicine

University of Washington

Rutgers Cancer Institute of New Jersey

Provision Center for Proton Therapy

Mayo Clinic

University of Maryland, College Park

University Hospitals Cleveland Medical Center

University of Florida Proton Therapy Institute

More Information

No publications provided

Responsible Party: Principal Investigator Massachusetts General Hospital Jason Efstathiou Principal Investigator
ClinicalTrials.gov Identifier: NCT01617161
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Massachusetts General Hospital:

Low Risk

Intermediate Risk

Additional relevant MeSH terms:

Prostatic Neoplasms

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on January 20, 2021