Try the modernized beta website. Learn more about the modernization effort.
Working… Menu
Trial record 1 of 1 for:    PARTIQoL 11-497
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01617161
Recruitment Status : Recruiting
First Posted : June 12, 2012
Last Update Posted : November 1, 2021
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):
Jason Efstathiou, Massachusetts General Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Radiation: Proton Beam Therapy Radiation: Intensity Modulated Radiation Therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 25, 2012
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Efficacy of PBT vs. IMRT [ Time Frame: 2 years ]
    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 :
  1. Disease Specific Quality of Life [ Time Frame: 2 years ]
    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

  2. Cost Effectiveness of PBT vs. IMRT [ Time Frame: 2 years ]
    Assess the cost-effectiveness of PBT versus IMRT under current conditions and model future cost-effectiveness for alternative treatment delivery and cost scenarios

  3. Radiation Dose and Bowel, Urinary and Erectile Function [ Time Frame: 2 years ]
    Develop predictive models to examine the associations between selected metrics of individual radiation dose distributions and patient reported bowel, urinary and erectile function

  4. Identification and Evaluation Biomarkers of PCa Behavior [ Time Frame: 2 years ]
    Identify and evaluate biomarkers of prostate cancer behavior and response to radiotherapy

  5. Long Term Survival [ Time Frame: 10 years ]
    Assess longer-term rates of disease-specific and overall survival as well as development of late effects such as second cancers

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01617161

Layout table for location information
United States, Florida
University of Florida Health Proton Therapy Institute Recruiting
Jacksonville, Florida, United States, 32206
Contact: Nancy Mendenhall, MD    904-588-1475   
United States, Illinois
Northwestern Medicine Chicago Proton Center Recruiting
Chicago, Illinois, United States, 60190
Contact: William Hartsell, MD    630-821-6400   
United States, Maryland
University of Maryland Medical Center Recruiting
College Park, Maryland, United States, 20742
Contact: Mark Mishra, MD    410-328-6080   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jason A Efstathiou, MD, DPhil    617-726-5866   
Principal Investigator: Jason A. Efstathiou, MD,DPhil         
Mass General/North Shore Cancer Center Recruiting
Danvers, Massachusetts, United States, 01923
Contact: Derek Chism, MD    978-882-6060    DCHISM@PARTNERS.ORG   
Principal Investigator: Derek Chism, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Thomas Pisansky, MD    507-284-2511   
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jeff Michalski, MD, MBA    314-362-8566   
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Rahul Parikh, MD    732-253-3939   
Princeton ProCure Proton Therapy Center Recruiting
Somerset, New Jersey, United States, 08873
Contact: Edward Soffen, MD    609-655-5755   
United States, Ohio
University Hospital of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Contact: Rodney Ellis, MD    216-286-3903      
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Justin E. Bekelman, MD    215-662-7266   
United States, Tennessee
Provision Proton Therapy Center Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Ben Wilkinson, MD    865-862-1600   
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Jing Zeng, MD    206-598-4100   
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
Layout table for investigator information
Principal Investigator: Jason A Efstathiou, MD, DPhil Massachusetts General Hospital
Principal Investigator: Justin E Bekelman, MD University of Pennsylvania
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jason Efstathiou, Principal Investigator, Massachusetts General Hospital Identifier: NCT01617161    
Other Study ID Numbers: 11-497
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Keywords provided by Jason Efstathiou, Massachusetts General Hospital:
Low Risk
Intermediate Risk
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases