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Radiation Therapy

Hypofractionated Radiation Therapy for Prostate Cancer

Phase 2
Waitlist Available
Led By Danny Song, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed, locally confined adenocarcinoma of the prostate
Clinical stages T1a to T2b PSA of less than 10 ng per ml
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights

Study Summary

This trial will test a new, more effective radiation therapy regimen for prostate cancer.

Who is the study for?
Men with early-stage prostate cancer (Gleason score <7, PSA <10 ng/ml, stages T1a-T2b) who have chosen external beam radiation as their treatment can join. They must sign a consent form. Men with advanced cancer, high Gleason scores or PSA levels, previous major treatments for prostate cancer, other recent cancers (except certain skin/bladder cancers), inflammatory bowel disease, or serious medical/psychiatric issues cannot participate.Check my eligibility
What is being tested?
The trial is testing a specific type of radiation therapy called hypofractionation to see if it's effective and safe in treating localized adenocarcinoma of the prostate. This Phase II study builds on earlier research suggesting that this approach could control tumors better than conventional therapy.See study design
What are the potential side effects?
While not specified here, radiation therapies like hypofractionation may cause side effects such as skin irritation at the treatment site, fatigue, urinary issues including increased frequency and discomfort during urination, bowel changes like diarrhea or rectal bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is confirmed and has not spread outside the prostate.
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My prostate cancer is in an early stage and my PSA level is below 10 ng/ml.
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My prostate cancer has a low Gleason score.
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I have chosen external beam radiation to treat my prostate cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess the incidence of grade 2 or greater GU and GI toxicity and self-reported quality of life data with image-guided radiation therapy in doses of 3.6 Gy per day to a total dose of 57.6Gy (16 fractions).
Secondary outcome measures
Assess biochemical and clinical control rates associated with the hypofractionated dose regimen for both low-risk and intermediate-risk groups. Assessment will be performed at median 4 years and again at median 7 years' follow-up.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hypofractionated radiation therapy in prostate adenocarcinomaExperimental Treatment1 Intervention
Participants with histologically confirmed, locally confined adenocarcinoma of the prostate receive 3.6 Gy per day to a total dose of 57.6 Gy (16 fractions).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
hypofractionation
2013
Completed Phase 2
~350

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
554 Previous Clinical Trials
32,723 Total Patients Enrolled
56 Trials studying Prostate Cancer
3,190 Patients Enrolled for Prostate Cancer
Danny Song, MDPrincipal InvestigatorThe Johns Hopkins University School of Medcine

Media Library

Hypofractionation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00809991 — Phase 2
Prostate Cancer Research Study Groups: Hypofractionated radiation therapy in prostate adenocarcinoma
Prostate Cancer Clinical Trial 2023: Hypofractionation Highlights & Side Effects. Trial Name: NCT00809991 — Phase 2
Hypofractionation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00809991 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people currently being recruited for this trial?

"According to the latest information available on clinicaltrials.gov, this particular trial is not actively recruiting patients at this time. This study was originally posted on December 22nd, 2008 and was last updated on March 18th, 2022. Even though this specific trial is no longer looking for participants, there are 2095 other studies that are currently seeking candidates."

Answered by AI

Has the FDA given its blessing to hypofractionation?

"Given that this is a Phase 2 trial, and thus there is only evidence of safety and no efficacy, our team at Power has given hypofractionation a score of 2."

Answered by AI

Would this research be beneficial for octogenarians?

"Eligible patients for this study must be aged 18 or over, but not yet 100 years old."

Answered by AI

Are there any restrictions on who is eligible to participate in this research?

"Researchers conducting this study are looking for 188 men, aged 18 to 100, who have been diagnosed with prostate cancer and meet the following additional requirements: The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer, Histologically confirmed, locally confined adenocarcinoma of the prostate, Clinical stages T1a to T2b PSA of less than 10 ng per ml, Gleason score of less than 3+4=7, Signed study-specific consent form prior to registration."

Answered by AI
~13 spots leftby Jun 2025