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Brachytherapy

External Beam Radiation Therapy for Prostate Cancer

Phase 3
Waitlist Available
Led By Bradley R. Prestidge, MD
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
Histologically confirmed adenocarcinoma of the prostate
T1c-T2b, N0, M0
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to last follow-up. analysis occurs after all patients had been on study for at least 5 years. maximum follow-up at time of analysis was 13.9 years.
Awards & highlights

Study Summary

This trial is comparing two ways of doing radiation therapy for prostate cancer to see which is more effective.

Eligible Conditions
  • Prostate Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to last follow-up. analysis occurs after all patients had been on study for at least 5 years. maximum follow-up at time of analysis was 13.9 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to last follow-up. analysis occurs after all patients had been on study for at least 5 years. maximum follow-up at time of analysis was 13.9 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
5-Year Freedom From Progression Rate
Secondary outcome measures
Biochemical Failure (Phoenix Definition)
Biochemical Failure Rate (Protocol Definition)
Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 24 Months
+11 more
Other outcome measures
Feasibility of Collecting Medicare Data in a Large RTOG Prostate Cancer Clinical Trial for Cost Effectiveness and Cost Utility Analysis of Combined Treatment With Interstitial Brachytherapy and External Beam Radiotherapy

Side effects data

From 2021 Phase 3 trial • 926 Patients • NCT01414608
79%
Fatigue
76%
Nausea
73%
Diarrhea
71%
Lymphocyte count decreased
65%
Anemia
36%
Vomiting
35%
Abdominal pain
31%
Vaginal discharge
31%
Platelet count decreased
28%
Pelvic pain
26%
Neutrophil count decreased
24%
Peripheral sensory neuropathy
22%
General disorders NOS
20%
Cystitis noninfective
17%
Alanine aminotransferase increased
16%
Pain in extremity
14%
Dermatitis radiation
12%
Creatinine increased
12%
Dehydration
11%
Vaginal pain
10%
Myalgia
10%
Hemorrhage Bladder
9%
Aspartate aminotransferase increased
9%
Hearing impaired
8%
Proctitis
8%
Vaginal dryness
8%
Alopecia
7%
Hemorrhage Rectum
7%
Vaginal stricture
6%
Mucositis oral
6%
Thrombosis/Thrombus/Embolism
6%
Urinary tract pain
4%
Allergic reaction/ hypersensitivity
4%
Rectal pain
3%
Anal pain
3%
Colitis
3%
Lymphedema
2%
Perineal pain
2%
Telangiectasia
2%
Enterocolitis
2%
Febrile neutropenia
2%
Female genital tract fistula
2%
Peripheral motor neuropathy
2%
Tumour pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Chemoradiation
Standard Chemoradiation With Adjuvant Chemotherapy

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EBRT + BrachytherapyExperimental Treatment2 Interventions
External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110)
Group II: Brachytherapy OnlyActive Control1 Intervention
Transperineal interstitial permanent brachytherapy (125/145)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brachytherapy (100/110)
2003
Completed Phase 3
~590
External Beam Radiation Therapy
2006
Completed Phase 3
~3070

Find a Location

Who is running the clinical trial?

Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
64,339 Total Patients Enrolled
32 Trials studying Prostate Cancer
20,003 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,058 Total Patients Enrolled
559 Trials studying Prostate Cancer
506,566 Patients Enrolled for Prostate Cancer
NRG OncologyOTHER
231 Previous Clinical Trials
100,236 Total Patients Enrolled
19 Trials studying Prostate Cancer
11,713 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.

If I enroll, am I allowed to participate in this clinical research?

"Prostate cancer patients aged 18 to 120 are encouraged to apply for this trial. Key requirements for applicants include: being in stages T1c to T2b, having no regional or distant metastases, no prior performance issues, and an American Urological Association voiding symptom score of 15 or lower."

Answered by AI

Has EBRT been cleared by the FDA for cancer treatments?

"While not without its risks, external beam radiation therapy has been shown to be effective and safe in multiple rounds of clinical trials."

Answered by AI

Are individuals needed for this experiment at present?

"This particular clinical trial, which was posted on June 1st 2003 and last updated on November 2nd 2021, is not currently recruiting patients. Although, there are 1352 other trials that are recruiting patients."

Answered by AI

Could elderly patients over the age of 70 still benefit from this clinical trial?

"This trial is open to patients aged 18 and up, with a maximum age limit of 120 years old."

Answered by AI
~27 spots leftby Mar 2025