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Postoperative Radiotherapy for Prostate Cancer
N/A
Recruiting
Led By Randal H Henderson, MD
Research Sponsored by Proton Collaborative Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prostate cancer treated primarily with open, laparoscopic or robotically assisted prostatectomy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after the end of radiation therapy
Awards & highlights
Study Summary
This trial is testing proton radiation and/or conventional radiation and hormonal therapy to see if it helps stop prostate cancer from coming back or reducing the risk of it returning.
Who is the study for?
This trial is for men who've had surgery for prostate cancer with a maximum PSA of 20 ng/ml and no distant metastasis. It's not for those with hip replacements, active inflammatory bowel disease affecting the rectum, other cancers (except certain skin cancers) within the last 5 years, previous chemotherapy, or pelvic radiation that affects this treatment.Check my eligibility
What is being tested?
The study tests whether proton radiation alone or combined with conventional radiation and possibly hormonal therapy can prevent prostate cancer from returning after surgery. Different doses and combinations are compared to find out which is more effective.See study design
What are the potential side effects?
Potential side effects include irritation of the bladder and bowels leading to increased frequency or discomfort when urinating or having bowel movements, fatigue, skin reactions in treated areas, and erectile dysfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer was treated with surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after the end of radiation therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after the end of radiation therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The treatment-related rate of acute grade 3 gastrointestinal and genitourinary toxicity following treatment with proton based radiation therapy.
Secondary outcome measures
Collect and analyze quality of life, treatment-related morbidity, disease control and survival outcome parameters
Trial Design
4Treatment groups
Experimental Treatment
Group I: Salvage Non-High RiskExperimental Treatment1 Intervention
Proton to 70.2 CGE
Group II: Salvage High RiskExperimental Treatment1 Intervention
IMRT to 45 Gy; proton boost to prostate bed to 25.2 CGE
Group III: Postop Non-High RiskExperimental Treatment1 Intervention
Proton to 66.6 CGE
Group IV: Postop High RiskExperimental Treatment1 Intervention
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE
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Who is running the clinical trial?
Proton Collaborative GroupLead Sponsor
9 Previous Clinical Trials
41,064 Total Patients Enrolled
3 Trials studying Prostate Cancer
344 Patients Enrolled for Prostate Cancer
University of Florida HealthOTHER
9 Previous Clinical Trials
4,363 Total Patients Enrolled
Randal H Henderson, MDPrincipal InvestigatorUniversity of Florida Proton Therapy Institute
2 Previous Clinical Trials
228 Total Patients Enrolled
1 Trials studying Prostate Cancer
228 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to distant parts of my body.I've had radiation to my pelvis that affects new treatments.I have been cancer-free for at least 5 years, except for non-melanoma skin cancer.I do not have active inflammation in my bowel affecting the rectum.My prostate cancer was treated with surgery.I am taking Saw Palmetto or methotrexate and cannot or do not want to stop during radiation.I have had chemotherapy before for any condition.
Research Study Groups:
This trial has the following groups:- Group 1: Salvage Non-High Risk
- Group 2: Postop High Risk
- Group 3: Salvage High Risk
- Group 4: Postop Non-High Risk
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.
How many individuals have been included in this investigation?
"Affirmative. The clinical trial webpage on clinicaltrials.gov indicates that recruitment is ongoing for this study, which was initially posted in August 2009 and last updated October 2021. It needs to recruit 70 participants from 3 medical centres."
Answered by AI
Is enrollment in this trial currently available to participants?
"Affirmative. According to the clinicaltrials.gov portal, this medical study is currently recruiting participants - first posted on August 1st 2009 and last updated October 24th 2021. The research team requires 70 patients from three distinct sites for enrollment."
Answered by AI
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