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Hormone Therapy

Androgen-Deprivation + Radiation Therapy for Prostate Cancer

Phase 3

Waitlist Available

Led By Mack Roach, 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

Zubrod performance status 0-1

No acquired immune deficiency syndrome (AIDS)

Must not have

Not willing/able to use medically acceptable forms of contraception

Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying androgen-deprivation therapy and radiation therapy to see how well they work in treating patients with prostate cancer.

Who is the study for?

Men with moderate to high-risk prostate cancer, confirmed by biopsy within the last 180 days. They should have a PSA level under 50 ng/mL and no bone metastases. Men previously on active surveillance for low risk prostate cancer who now have higher risk disease may also join if re-biopsied within 180 days. No prior pelvic radiation or radical prostate surgery is allowed, and they must be willing to use contraception.

What is being tested?

This phase III trial is testing whether combining androgen-deprivation therapy (which lowers male hormones) with whole-pelvic radiotherapy (a type of radiation that targets the entire pelvic area) is effective in treating patients with prostate cancer compared to other treatments.

What are the potential side effects?

Possible side effects include hot flashes, reduced sexual desire, fatigue, urinary issues like increased frequency or discomfort, bowel changes such as diarrhea, skin irritation in treated areas, and potential long-term impacts on heart health.

Eligibility Criteria

Inclusion Criteria

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

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I can carry out all my usual activities without help.

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I do not have AIDS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not willing or able to use birth control.

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I have had radiation to my pelvis, seed implants in my prostate, or both testicles removed.

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I have had a condition where my lymphocytes grow abnormally.

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I have a history of cancer.

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I have had hormone therapy for prostate cancer.

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I have AIDS.

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I have had blood cancer before.

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I have had major surgery for prostate cancer.

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I have had radiation to my pelvis, seed implants in my prostate, or both testicles removed.

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I have received hormone therapy for prostate cancer.

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I have not taken Finasteride in the last 30 days.

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I have not taken Dutasteride or Jalyn in the last 90 days.

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I have received chemotherapy for prostate cancer.

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I have had radiation therapy on the cancer area being studied.

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I have not had any other cancer besides this one in the last 3 years.

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I have had major surgery or cryosurgery for prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm IIExperimental Treatment1 Intervention

Patients undergo whole-pelvic radiotherapy (WPRT)\* (3D-CRT or IMRT) once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo brachytherapy as in arm I.

Group II: Arm IActive Control1 Intervention

Patients undergo high-dose radiotherapy of the prostate and seminal vesicles using intensity-modulated radiotherapy (IMRT)\* or 3D-conformal radiation therapy (3D-CRT)\* once daily, 5 days a week, for approximately 9 weeks. Patients may also undergo permanent prostate implant (PPI) brachytherapy or high-dose rate brachytherapy (I 125 or Pd 103 may be used as the radioisotope).

0 / 18Eligibility criteria met