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Types of Radiation Therapy for Prostate Cancer
Phase 3
Waitlist Available
Led By Mark Buyyounouski
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adenocarcinoma of the prostate treated primarily with radical prostatectomy
No clinical evidence of regional lymph node metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to last follow-up. maximum follow-up at time of analysis was 3.0 years.
Awards & highlights
Study Summary
This trial compares two types of radiation therapy given after surgery to treat prostate cancer. One type delivers higher doses of radiation over a shorter period of time, and the other uses lower doses given over a longer period of time. Researchers want to see which type works better.
Who is the study for?
Men who've had prostate surgery for adenocarcinoma, with certain pathology results (pT2 or pT3), and no evidence of metastasis. They must have a PSA level < 2.0 ng/mL post-surgery, good performance status, and be able to complete questionnaires in English or French. Excluded are those with prior long-term hormone therapy, other recent cancers except non-melanoma skin cancer, severe health issues like heart failure or uncontrolled infections.Check my eligibility
What is being tested?
The trial is comparing two types of radiation therapy after prostate surgery: hypofractionated (higher doses over a shorter period) versus conventional (standard doses over a longer period). The goal is to see which method is more effective at killing tumor cells with fewer side effects.See study design
What are the potential side effects?
Radiation therapy may cause fatigue, skin irritation at the treatment site, frequent urination, discomfort during urination, rectal bleeding or irritation, erectile dysfunction and bowel changes such as diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had surgery to remove my prostate cancer.
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My cancer has not spread to nearby lymph nodes.
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My cancer is classified as either pT2 or pT3.
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My surgery showed cancer cells at the edge of the tissue removed.
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My PSA level was below 2.0 ng/mL after my prostate surgery.
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My scans show no bone metastases.
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I speak English or French.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization to last follow-up. maximum follow-up at time of analysis was 3.0 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to last follow-up. maximum follow-up at time of analysis was 3.0 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Bowel Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years
Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years
Secondary outcome measures
Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 Years
Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 Years
Number of Participants With Grade 3+ Adverse Events
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hypofractionated radiation therapyExperimental Treatment2 Interventions
Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.
Group II: Conventional radiation therapyActive Control2 Interventions
Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated radiation therapy
2009
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,556 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,857 Total Patients Enrolled
Mark BuyyounouskiPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
163 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had surgery to remove my prostate cancer.I have been on hormone therapy for prostate cancer for more than 6 months before surgery.I have received chemotherapy before or after surgery to remove my prostate.I haven't had chemotherapy for another condition in the last 3 years.I had an MRI to check for a prostate mass after unclear exam results.My prostate cancer was stage pT2, surgery removed it all, and my PSA is under 0.1 ng/mL.My cancer has not spread to nearby lymph nodes.I've had radiation therapy in the same area as my current cancer.My lowest PSA level after prostate surgery was 0.2 or higher and my cancer is aggressive.I started hormone therapy for prostate cancer more than 6 weeks ago.I have had a prostate removal surgery, regardless of the method or time.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer or cancers in the pelvis.My cancer is classified as either pT2 or pT3.My surgery showed cancer cells at the edge of the tissue removed.My pelvic lymph nodes are less than or equal to 1 cm in size.I have been mostly active and able to carry on all pre-disease activities without restriction in the last 60 days.My biopsy was negative for cancer despite uncertain exam results.My scans show no bone metastases.My PSA level was below 2.0 ng/mL after my prostate surgery.I've had a CT or MRI of my pelvis, or a biopsy, within the last 4 months.I had surgery to remove lymph nodes in my pelvis, and I know how many were taken out and the type of surgery.My recent exam showed no signs of cancer returning in the prostate area.I speak English or French.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional radiation therapy
- Group 2: Hypofractionated radiation therapy
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.
Has the FDA sanctioned Hypofractionated Radiation Therapy?
"There is some evidence of efficacy and multiple rounds of data supporting safety, so our team at Power estimates that the safety of Hypofractionated Radiation Therapy rates a 3 on a scale from 1 to 3."
Answered by AI
Who else is applying?
What site did they apply to?
University of Texas Medical Branch
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I am wanting to see what my options are before getting into chemo and or radiation.
PatientReceived no prior treatments
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