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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.
Must not have
Patients with all three intermediate risk factors who also have ≥ 50% of the number of their biopsy cores positive for cancer are ineligible for this trial.
Use of dutasteride within 90 days prior to registration.
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

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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I can carry out all my usual activities without help.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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More than half of my biopsy samples show cancer, making me ineligible.
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I have not taken dutasteride in the last 90 days.
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I have undergone hormone therapy or surgical removal of my testicles for cancer treatment.
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I have had surgery or specific treatments for prostate cancer.
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I am currently on IV antibiotics for a bacterial or fungal infection.
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I had a major heart attack in the last 6 months.
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I have had radiation therapy in the same area as my current cancer.
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I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.
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I am a man who will not use contraception during and 3 months after treatment.
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I have been cancer-free for at least 5 years, except for non-melanoma skin cancer.
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My prostate cancer is not advanced (Gleason < 8, PSA ≤ 20, Stage < T3).
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I haven't been hospitalized for lung problems in the last 30 days.

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
232 Previous Clinical Trials
99,211 Total Patients Enrolled
19 Trials studying Prostate Cancer
10,763 Patients Enrolled for Prostate Cancer
Radiation Therapy Oncology GroupLead Sponsor
190 Previous Clinical Trials
63,388 Total Patients Enrolled
32 Trials studying Prostate Cancer
19,053 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,957,863 Total Patients Enrolled
565 Trials studying Prostate Cancer
527,467 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
~97 spots leftby Jul 2025
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