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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
Must not have
Evidence of distant metastasis (M1)
Previous irradiation to the pelvis that would compromise the ability to deliver the prescribed study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
Select...
My prostate cancer was treated with surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has spread to distant parts of my body.
Select...
I've had radiation to my pelvis that affects new treatments.
Select...
I am taking Saw Palmetto or methotrexate and cannot or do not want to stop during radiation.
Select...
I have had chemotherapy before for any condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

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

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

Find a Location

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
4,034 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

IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00969111 — N/A
Prostate Cancer Research Study Groups: Salvage Non-High Risk, Postop High Risk, Salvage High Risk, Postop Non-High Risk
Prostate Cancer Clinical Trial 2023: IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE Highlights & Side Effects. Trial Name: NCT00969111 — N/A
IMRT to 45 Gy; prostate bed proton boost of 21.6 CGE (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00969111 — N/A
~21 spots leftby Aug 2031
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