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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

Pivotal Trial

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to last follow-up. maximum follow-up at time of analysis was 10.3 years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Alive (Overall Survival)

Secondary study objectives

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

+13 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

Hormone Toxicity: Liver : NOS

Late RT Toxicity: Other: NOS

Late RT Toxicity: Other GU: NOS

100%

80%

60%

40%

20%

Study treatment Arm

Neoadjuvant TAS 2 Months Before and During RT

Radiation Therapy Alone

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 16Eligibility criteria met