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

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Proton Beam Therapy
Intensity Modulated Radiation Therapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Low Risk, Intermediate Risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida Health Proton Therapy Institute
  • Northwestern Medicine Chicago Proton Center
  • University of Maryland Medical Center
  • Massachusetts General Hospital
  • Mass General/North Shore Cancer Center
  • Mayo Clinic
  • Washington University
  • Rutgers Cancer Institute of New Jersey
  • Princeton ProCure Proton Therapy Center
  • University Hospital of Cleveland
  • Hospital of the University of Pennsylvania
  • Provision Proton Therapy Center
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PBT

IMRT

Arm Description

Proton Beam Therapy

Intensity Modulated Radiation Therapy

Outcomes

Primary Outcome Measures

Efficacy of PBT vs. IMRT
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

Disease Specific Quality of Life
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
Cost Effectiveness of PBT vs. IMRT
Assess the cost-effectiveness of PBT versus IMRT under current conditions and model future cost-effectiveness for alternative treatment delivery and cost scenarios
Radiation Dose and Bowel, Urinary and Erectile Function
Develop predictive models to examine the associations between selected metrics of individual radiation dose distributions and patient reported bowel, urinary and erectile function
Identification and Evaluation Biomarkers of PCa Behavior
Identify and evaluate biomarkers of prostate cancer behavior and response to radiotherapy
Long Term Survival
Assess longer-term rates of disease-specific and overall survival as well as development of late effects such as second cancers

Full Information

First Posted
June 8, 2012
Last Updated
August 22, 2022
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 Medical Center, University Hospitals Cleveland Medical Center, University of Florida Proton Therapy Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01617161
Brief Title
Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer
Acronym
PARTIQoL
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 25, 2012 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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 Medical Center, University Hospitals Cleveland Medical Center, University of Florida Proton Therapy Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Low Risk, Intermediate Risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
454 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PBT
Arm Type
Active Comparator
Arm Description
Proton Beam Therapy
Arm Title
IMRT
Arm Type
Active Comparator
Arm Description
Intensity Modulated Radiation Therapy
Intervention Type
Radiation
Intervention Name(s)
Proton Beam Therapy
Intervention Description
5 days per week up to 9 weeks
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulated Radiation Therapy
Intervention Description
5 times per week up to 9 weeks
Primary Outcome Measure Information:
Title
Efficacy of PBT vs. IMRT
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)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Disease Specific Quality of Life
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
Time Frame
2 years
Title
Cost Effectiveness of PBT vs. IMRT
Description
Assess the cost-effectiveness of PBT versus IMRT under current conditions and model future cost-effectiveness for alternative treatment delivery and cost scenarios
Time Frame
2 years
Title
Radiation Dose and Bowel, Urinary and Erectile Function
Description
Develop predictive models to examine the associations between selected metrics of individual radiation dose distributions and patient reported bowel, urinary and erectile function
Time Frame
2 years
Title
Identification and Evaluation Biomarkers of PCa Behavior
Description
Identify and evaluate biomarkers of prostate cancer behavior and response to radiotherapy
Time Frame
2 years
Title
Long Term Survival
Description
Assess longer-term rates of disease-specific and overall survival as well as development of late effects such as second cancers
Time Frame
10 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason A Efstathiou, MD, DPhil
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Justin E Bekelman, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida Health Proton Therapy Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32206
Country
United States
Facility Name
Northwestern Medicine Chicago Proton Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
University of Maryland Medical Center
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mass General/North Shore Cancer Center
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Princeton ProCure Proton Therapy Center
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
University Hospital of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Provision Proton Therapy Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32972877
Citation
Liu Y, Patel SA, Jani AB, Gillespie TW, Patel PR, Godette KD, Hershatter BW, Shelton JW, McDonald MW. Overall Survival After Treatment of Localized Prostate Cancer With Proton Beam Therapy, External-Beam Photon Therapy, or Brachytherapy. Clin Genitourin Cancer. 2021 Jun;19(3):255-266.e7. doi: 10.1016/j.clgc.2020.08.009. Epub 2020 Aug 28.
Results Reference
derived

Learn more about this trial

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

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