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Radiation + Androgen-Deprivation Therapy for Prostate Cancer

Phase 3
Waitlist Available
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
Gleason score = 7
Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma, at intermediate risk for recurrence, within 180 days prior to registration as determined by having one or more of the following intermediate-risk features: Gleason score 7; prostate-specific antigen (PSA) >10 but ≤20; clinical stage T2b-T2c.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to last follow-up. maximum follow-up at time of analysis was 10.3 years.
Awards & highlights

Study Summary

This trial is comparing radiation therapy alone to radiation therapy with androgen-deprivation therapy to see which is more effective in treating prostate cancer.

Who is the study for?
Men aged 18+ with intermediate-risk prostate cancer, characterized by specific Gleason scores, PSA levels, and clinical stages. Participants must have no severe co-morbidities or prior treatments like radical surgery for prostate cancer. They should not have used certain medications recently and must be free of other cancers for at least 5 years.Check my eligibility
What is being tested?
This phase III trial is testing the effectiveness of radiation therapy alone versus in combination with androgen-deprivation therapy (ADT) in men with prostate cancer. ADT aims to reduce male hormones that can promote tumor growth.See study design
What are the potential side effects?
Radiation may cause skin irritation, fatigue, urinary issues, bowel problems, and sexual dysfunction. Androgen-deprivation therapy might lead to hot flashes, reduced libido, weight gain, bone thinning, mood changes and increased risk of heart disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer has a Gleason score of 7.
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My prostate cancer is at an intermediate risk of coming back, based on recent tests.
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My prostate cancer was low risk but is now intermediate risk after a recent biopsy.
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I've had a recent exam focusing on my prostate, bones, abdomen, and overall health.
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I can carry out all my usual activities without help.
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I am 18 years old or older.
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My lymph nodes do not show cancer on scans or tests done in the last 60 days.
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I may need a pelvic or abdominal scan based on my risk factors.
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My PSA test was not done too soon after certain prostate procedures or medication changes.
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I may not need a bone scan if I have only one risk factor, but I must have a negative bone scan if I have 2 or 3 risk factors.
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My hemoglobin level is at least 8.0 g/dl.
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My recent blood test shows my bone marrow is functioning well.
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My recent scans show no cancer spread to bones.
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My lymph nodes are either not clearly affected by cancer on scans, or if any are larger than 1.5 cm, they've been biopsied and found to be cancer-free.
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My bone scan was unclear, but x-rays showed no cancer spread to bones.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to last follow-up. maximum follow-up at time of analysis was 10.3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to last follow-up. maximum follow-up at time of analysis was 10.3 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
Percentage of Participants Alive (Overall Survival)
Secondary outcome measures
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Score
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Score
+15 more

Side effects data

From 2018 Phase 3 trial • 2028 Patients • NCT00002597
44%
Acute RT Toxicity: Bowel: NOS
29%
Hormone Toxicity: Hot flashes : NOS
26%
Late RT Toxicity: Bowel: NOS
24%
Hormone Toxicity: Impotence : NOS
18%
Late RT Toxicity: Bladder: NOS
17%
Hormone Toxicity: Hematologic : NOS
15%
Acute RT Toxicity: Bladder: NOS
13%
Acute RT Toxicity: Hematologic: NOS
13%
Late RT Toxicity: Hematologic: NOS
13%
Acute RT Toxicity: Other: NOS
9%
Hormone Toxicity: Liver : NOS
8%
Late RT Toxicity: Other: NOS
7%
Late RT Toxicity: Other GU: NOS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Neoadjuvant TAS 2 Months Before and During RT
Radiation Therapy Alone

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Dose-Escalated Radiation Therapy and Short-Term Androgen-DeprivationExperimental Treatment4 Interventions
Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions. Six months of androgen-deprivation therapy starts 8 weeks prior to start of radiation therapy and consists of luteinizing-hormone releasing-hormone (LHRH) agonist (antagonist) therapy (leuprolide, goserelin, buserelin. triptorelin, or degarelix) and anti-androgen therapy (bicalutamide or flutamide).
Group II: Dose-Escalated Radiation Therapy AloneActive Control1 Intervention
Radiation therapy consists of 79.2 Gy EBRT only or 45 Gy EBRT followed by low- or high-dose rate brachytherapy. EBRT is delivered in 1.8 Gy daily fractions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bicalutamide
FDA approved
Flutamide
FDA approved

Find a Location

Who is running the clinical trial?

NRG OncologyOTHER
231 Previous Clinical Trials
99,314 Total Patients Enrolled
19 Trials studying Prostate Cancer
10,763 Patients Enrolled for Prostate Cancer
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
63,389 Total Patients Enrolled
32 Trials studying Prostate Cancer
19,053 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,931,615 Total Patients Enrolled
560 Trials studying Prostate Cancer
505,635 Patients Enrolled for Prostate Cancer

Media Library

Prostate Cancer Research Study Groups: Dose-Escalated Radiation Therapy Alone, Dose-Escalated Radiation Therapy and Short-Term Androgen-Deprivation

Frequently Asked Questions

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

Is flutamide a common active ingredient in medical research?

"At the moment, there are 138 clinical trials underway that are studying flutamide. Out of these, 50 are in Phase 3. Flutamide trials are being conducted at 10008 locations, with many of them being in Duarte, California."

Answered by AI

What is the health risk associated with flutamide?

"Flutamide's safety is based on multiple rounds of Phase 3 clinical trials, meaning that there is some evidence of the drug's efficacy as well as data supporting its safety."

Answered by AI

Are there any patients currently being recruited for this research project?

"This study is no longer recruiting patients. The listing for this clinical trial was created on September 1st, 2009 and was last updated on September 7th, 2022. If you are interested in alternative studies, there are 1348 trials for prostate cancer and 138 for flutamide that are still enrolling patients."

Answered by AI

In how many sites is this trial currently being conducted?

"This study is based out of Rex Cancer Center in Raleigh, North carolina but has satellite locations in 100 other places, such as Saint Anthony's Health in Alton, Illinois, and Huron Valley-Sinai Hospital in Commerce, Michigan."

Answered by AI

What is the primary illness that flutamide has been shown to improve?

"Flutamide has many potential medical uses, such as treating breast cancer, endometrial thinning, and as a means of preparing for certain therapeutic procedures."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Inova Alexandria Hospital
~99 spots leftby Apr 2025