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Intensity Modulated Radiation Therapy

Proton Therapy vs. IMRT for Prostate Cancer (PARTIQoL Trial)

N/A
Waitlist Available
Led By Jason A Efstathiou, MD, DPhil
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
Must not have
Individuals who have AIDS (CD4 < 200 or an AIDS-defining illness) or are HIV positive and not on HAART therapy are ineligible
Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had a full health check and prostate exam recently.
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My cancer is in an early stage, but it's growing.
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My prostate cancer has a Gleason score of 6 or 7.
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My PSA level is below 20, measured within the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have AIDS or untreated HIV.
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I have had surgery or other treatments for prostate cancer.
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I do not have a severe lung condition that requires hospital care right now.
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I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.
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I had a major heart attack in the last 6 months.
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I am currently on IV antibiotics for a bacterial or fungal infection.
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I have undergone or plan to undergo hormone therapy or surgical removal of my testicles for cancer treatment.
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I have a hip prosthesis, inflammatory bowel disease, or a connective tissue disorder like scleroderma or lupus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of PBT vs. IMRT
Secondary study objectives
Cost Effectiveness of PBT vs. IMRT
Disease Specific Quality of Life
Identification and Evaluation Biomarkers of PCa Behavior
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,993 Previous Clinical Trials
2,295,628 Total Patients Enrolled
17 Trials studying Prostate Cancer
3,927 Patients Enrolled for Prostate Cancer
Northwestern Medicine Chicago Proton CenterUNKNOWN
University of Maryland Medical CenterUNKNOWN
2 Previous Clinical Trials
80 Total Patients Enrolled

Media Library

Intensity Modulated Radiation Therapy (Intensity Modulated Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01617161 — N/A
Prostate Cancer Research Study Groups: PBT, IMRT
Prostate Cancer Clinical Trial 2023: Intensity Modulated Radiation Therapy Highlights & Side Effects. Trial Name: NCT01617161 — N/A
Intensity Modulated Radiation Therapy (Intensity Modulated Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01617161 — N/A
~34 spots leftby Dec 2025
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