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Radiation Therapy

Hypofractionated 3D-CRT or IMRT for Prostate Cancer

Phase 3

Waitlist Available

Led By W. Robert Lee, MD, MS

Research Sponsored by Radiation Therapy Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up analysis occurs after all patients have been followed for five years.

Awards & highlights

Study Summary

This trial is studying different radiation therapy regimens to compare how well they work in treating stage II prostate cancer.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ acute toxicity is measured from start of treatment to 90 days from the completion of treatment. late toxicity is defined as toxicity occuring after 90 days from completion of treatment. analysis occured at the time of the primary endpoint analysis.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~acute toxicity is measured from start of treatment to 90 days from the completion of treatment. late toxicity is defined as toxicity occuring after 90 days from completion of treatment. analysis occured at the time of the primary endpoint analysis.

This trial's timeline: 3 weeks for screening, Varies for treatment, and acute toxicity is measured from start of treatment to 90 days from the completion of treatment. late toxicity is defined as toxicity occuring after 90 days from completion of treatment. analysis occured at the time of the primary endpoint analysis. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Five-year Disease-free Survival (DFS) Rate

Secondary outcome measures

Assessment of Trade-off Between Disease-free Survival and Quality of Life.

Change From Baseline in Assessment of Anxiety and Depression Using the HSCL-25

Comparison of Disease-specific HRQOL Change in Expanded Prostate Cancer Index Composite (EPIC); the Utilization of Sexual Medications/Devices Supplements the EPIC

+8 more

Other outcome measures

Collection of Paraffin-embedded Tissue Block, Serum, Plasma, and Buffy Coat Cells for Future Translational Research Analyses

Side effects data

From 2022 Phase 3 trial • 1116 Patients • NCT00331773

71%

Pollakiuria

37%

Erectile dysfunction NOS

32%

Diarrhea NOS

30%

Fatigue

23%

Urinary retention

22%

Proctitis NOS

16%

Rectal hemorrhage

16%

Renal/genitourinary - Other

16%

Cystitis NOS

12%

Urinary incontinence

10%

Constipation

Gastrointestinal - Other

Hemorrhoids

Pain - Other

Ejaculatory disorder NOS

Bladder pain

Libido decreased

Urethral pain

Fecal incontinence

Atrial fibrillation

Dyspnea

100%

80%

60%

40%

20%

Study treatment Arm

Conventional 3D-CRT

Hypofractionated 3D-CRT

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hypofractionated 3D-CRTExperimental Treatment1 Intervention

Hypofractionated 3D-CRT or IMRT to 70 Gy in 28 fractions

Group II: Conventional 3D-CRTActive Control1 Intervention

Conventional 3D-CRT or IMRT to 73.8 Gy in 41 fractions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionated 3D-CRT or IMRT

2006

Completed Phase 3

~1120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Radiation Therapy Oncology GroupLead Sponsor

190 Previous Clinical Trials

63,811 Total Patients Enrolled

32 Trials studying Prostate Cancer

19,475 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,652 Previous Clinical Trials

40,931,340 Total Patients Enrolled

560 Trials studying Prostate Cancer

506,057 Patients Enrolled for Prostate Cancer

NRG OncologyOTHER

231 Previous Clinical Trials

99,736 Total Patients Enrolled

19 Trials studying Prostate Cancer

11,185 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

Does the age range for this trial include people who are under 25 years old?

"In order to be eligible for this particular study, potential patients must between 18 and 120 years old. There are 80 clinical trials that focus on those under 18 while 1358 studies center around adults over the age of 65."

Answered by AI

Are researchers still recruiting for this clinical trial?

"According to the latest information on clinicaltrials.gov, this study is not looking for new participants at this time. Although the listing was last updated on April 19th, 2022, it's possible that this could change in the future. There are many other trials (1364) which are currently recruiting patients."

Answered by AI

How do I sign up for this experiment?

"The investigators conducting this clinical trial are looking for 1115 individuals with prostate cancer that fit the following profile: Between 18 and 120 years old, no regional lymph node involvement, combined Gleason score 2-6, no distant metastases, Zubrod performance status 0-1."

Answered by AI

Are patients at a higher risk for complications when treated with Hypofractionated 3D-CRT or IMRT?

"3D-CRT or IMRT have both received a score of 3 in terms of safety. This is due to the fact that this trial is a Phase 3, which signifies that there is data supporting efficacy as well as multiple rounds of data affirming safety."

Answered by AI

Are multiple hospitals in Canada conducting this research trial?

"This trial is actively recruiting 100 patients from across the United States, at locations such as NCT00331773 in Great Falls, Dana-Farber/Brigham and Women's Cancer Center in Boston, and Willamette Valley Cancer Center - Eugene in Eugene."

Answered by AI