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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

Must not have

Gleason 4+3=7 or higher score

Previous Chemotherapy or pelvic radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate cancer has a Gleason score of 7 or higher.

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I have had chemotherapy or radiation therapy to the pelvis before.

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I have a history of inflammatory bowel disease.

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My cancer has spread to nearby lymph nodes.

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My cancer is at an advanced local stage.

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My cancer has spread to distant parts of my body.

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I have had major surgery for prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

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

0 / 11Eligibility criteria met