Radiation + Androgen-Deprivation Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+517 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Radiation Therapy Oncology Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.

Research Team

Alvaro A. Martinez, MD, FACR

Principal Investigator

21st Century Oncology - Michigan Institute for Radiation Oncology

Eligibility Criteria

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.

Inclusion Criteria

My prostate cancer has a Gleason score of 7.

My prostate cancer is at an intermediate risk of coming back, based on recent tests.

Patient must be able to provide study-specific informed consent prior to study entry.

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Exclusion Criteria

More than half of my biopsy samples show cancer, making me ineligible.

I have not taken dutasteride in the last 90 days.

I am HIV positive but do not have AIDS.

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Treatment Details

Interventions

3-Dimensional Conformal Radiation Therapy (Radiation)
bicalutamide (Hormone Therapy)
buserelin (Hormone Therapy)
Dose-Escalated Radiation Therapy (Radiation)
flutamide (Hormone Therapy)
goserelin acetate (Hormone Therapy)
Intensity-Modulated Radiation Therapy (Radiation)
leuprolide acetate (Hormone Therapy)
triptorelin (Hormone Therapy)

Trial OverviewThis 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.

Participant Groups

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.

3-Dimensional Conformal Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications: