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Intensity Modulated Radiation Therapy
Proton Therapy vs. IMRT for Prostate Cancer (PARTIQoL Trial)
N/A
Waitlist Available
Led By Justin E Bekelman, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Clinical stages T1c to T2c
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
PARTIQoL Trial Summary
This trial is 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.
Who is the study for?
Men with low or intermediate risk prostate cancer, specifically adenocarcinoma based on biopsy within the last year. Eligible participants have a PSA level <20, Gleason score ≤7, and are in good physical condition (ECOG 0-1). They must not have had prior treatments for prostate cancer or other cancers unless disease-free for 5 years or at low risk of recurrence.Check my eligibility
What is being tested?
The study is comparing two external radiation treatments for prostate cancer: Intensity Modulated Radiation Therapy (IMRT) and Proton Beam Therapy (PBT). Both aim to target the cancer while sparing surrounding tissue. The goal is to determine which therapy better minimizes side effects like bowel, urinary, and erectile problems.See study design
What are the potential side effects?
Potential side effects from both IMRT and PBT include issues with bowel function, urination difficulties, and problems with erectile function. The trial aims to assess if one treatment results in fewer or less severe side effects than the other.
PARTIQoL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had a full health check and prostate exam recently.
Select...
My cancer is in an early stage, but it's growing.
Select...
My prostate cancer has a Gleason score of 6 or 7.
Select...
My PSA level is below 20, measured within the last 6 months.
PARTIQoL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of PBT vs. IMRT
Secondary outcome measures
Cost Effectiveness of PBT vs. IMRT
Disease Specific Quality of Life
Identification and Evaluation Biomarkers of PCa Behavior
+2 morePARTIQoL Trial Design
2Treatment groups
Active Control
Group I: PBTActive Control1 Intervention
Proton Beam Therapy
Group II: IMRTActive Control1 Intervention
Intensity Modulated Radiation Therapy
Find a Location
Who is running the clinical trial?
Washington University School of MedicineOTHER
1,931 Previous Clinical Trials
2,299,255 Total Patients Enrolled
17 Trials studying Prostate Cancer
3,817 Patients Enrolled for Prostate Cancer
Northwestern Medicine Chicago Proton CenterUNKNOWN
Provision Center for Proton TherapyOTHER
2 Previous Clinical Trials
535 Total Patients Enrolled
1 Trials studying Prostate Cancer
235 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to distant areas or lymph nodes, confirmed by a CT scan in the last year.I do not have AIDS or untreated HIV.I have had liver problems causing jaundice or blood clotting issues in the past year.I have had surgery or other treatments for prostate cancer.I do not have a severe lung condition that requires hospital care right now.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.I had a major heart attack in the last 6 months.I am currently on IV antibiotics for a bacterial or fungal infection.I have undergone or plan to undergo hormone therapy or surgical removal of my testicles for cancer treatment.I have a hip prosthesis, inflammatory bowel disease, or a connective tissue disorder like scleroderma or lupus.I was diagnosed with prostate cancer from a biopsy within the last year.I am taking or have recently taken Dutasteride or Finasteride, and my PSA is 10 or below.I have been cancer-free for 5 years or my previous cancer is unlikely to return according to my doctor.I am fully active or restricted in physically strenuous activity but can do light work.I've had a full health check and prostate exam recently.My cancer is in an early stage, but it's growing.My prostate cancer has a Gleason score of 6 or 7.My PSA level is below 20, measured within the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: PBT
- Group 2: IMRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the geographical scope of this experiment?
"Currently, there are 13 medical centres participating in this clinical trial. These sites can be found in Philadelphia, Saint Louis and Cleveland among other urban areas. When selecting a clinic to participate at, it is highly recommended to choose one closest to your residence for reduced travel requirements."
Answered by AI
Is this experiment recruiting participants at the moment?
"Based on the information listed on clinicaltrials.gov, this trial is not presently recruiting patients; however, it was initially posted in July 2012 and last updated in August 2022. Fortunately, there are 1,321 other trials that are currently accepting enrollees at this time."
Answered by AI
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