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Proton Beam Therapy
Short-Course Proton Radiation for Prostate Cancer
Phase 3
Waitlist Available
Research Sponsored by Proton Collaborative Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative
Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 5 years post treatment completion +/- 90 days
Awards & highlights
Study Summary
This trial is testing a more intense but shorter course of radiation therapy for prostate cancer patients to see if it is as effective as the current standard.
Who is the study for?
Men over 18 with low-risk prostate cancer, confirmed within the last year, can join. They should be in good physical shape (able to walk and care for themselves), have a Gleason score of 2-6, PSA under 10 ng/ml, and no history of certain prostate treatments or pelvic radiation. No major health issues that could affect participation are allowed.Check my eligibility
What is being tested?
This study tests two ways of giving proton radiation therapy for prostate cancer: the standard way with 44 treatments over about 9 weeks versus a higher daily dose given in just 5 treatments over one to two weeks. The goal is to see if the shorter treatment works as well or better.See study design
What are the potential side effects?
Proton radiation may cause side effects like skin redness, fatigue, frequent urination with discomfort or difficulty during treatment period. Long-term side effects might include changes in bowel habits and sexual function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pelvic lymph nodes are not enlarged over 1.5 cm, or if they are, they've been tested and are not cancerous.
Select...
My breast cancer is in an early stage and has not spread to lymph nodes or other parts of the body.
Select...
My prostate cancer has a low Gleason score (2-6) based on biopsy.
Select...
I am 18 years old or older.
Select...
I can start treatment within 56 days of being chosen for the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 5 years post treatment completion +/- 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 5 years post treatment completion +/- 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.
Secondary outcome measures
To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Proton Radiation HypofractionationExperimental Treatment1 Intervention
5 fractions (7.6 Gy(RBE) x 5)
Group II: Proton Radiation Standard FractionationActive Control1 Intervention
44 fractions (1.8 Gy(RBE) x 44)
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Who is running the clinical trial?
Proton Collaborative GroupLead Sponsor
9 Previous Clinical Trials
40,984 Total Patients Enrolled
3 Trials studying Prostate Cancer
264 Patients Enrolled for Prostate Cancer
Carlos Vargas, MDStudy ChairProton Collaborative Group
4 Previous Clinical Trials
40,209 Total Patients Enrolled
2 Trials studying Prostate Cancer
194 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer was confirmed by a lab test within the last year.I have active inflammation or infection in my rectum due to diverticulitis, Crohn's disease, or ulcerative colitis.My pelvic lymph nodes are not enlarged over 1.5 cm, or if they are, they've been tested and are not cancerous.My PSA level was below 10 ng/ml within the last 3 months.My breast cancer is in an early stage and has not spread to lymph nodes or other parts of the body.I am currently on blood thinners that can be paused for treatment if necessary.I have received chemotherapy for prostate cancer before.I haven't had any cancer other than non-dangerous skin cancer in the last 5 years.I've had a prostate exam and toxicity check within the last 3 months.My prostate cancer has a low Gleason score (2-6) based on biopsy.I am 18 years old or older.I have had surgery for prostate cancer, including removal, heating, or freezing of the prostate.I have received hormone therapy for cancer before radiation but not during or after it.I am fully active or restricted in physically strenuous activity but can do light work.I have had a blockage in my urethra that needed stretching.I have had radiation therapy for prostate cancer in the pelvic area.I can start treatment within 56 days of being chosen for the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Proton Radiation Standard Fractionation
- Group 2: Proton Radiation Hypofractionation
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Does Proton Radiation Standard Fractionation have FDA approval?
"Proton Radiation Standard Fractionation has received a safety score of 3. This is because there is both efficacy data and multiple rounds of safety data available, as this is a Phase 3 trial."
Answered by AI
Is this clinical trial being run at multiple facilities within the US?
"There are six locations where this study is being conducted; these include sites in Phoenix, Warrenville, and Baltimore. Additionally, there are six other sites where this study is being conducted. It is worth noting that enrolling at a location nearest to you will minimize travel."
Answered by AI
Are participants currently being recruited for this research?
"The study in question is not recruiting patients at the moment, however, this could change in the future. According to the clinicaltrials.gov listing, the trial was first posted on November 1st, 2010 and was last updated on October 24th, 2021. There are currently 1,348 other clinical trials that are actively seeking patients."
Answered by AI
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