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Antiandrogen

Anti-Testosterone Drugs + Radiation Therapy for Prostate Cancer

Phase 2

Waitlist Available

Led By Sean M McBride, MD, MPH

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males 18 years of age and above

Radiographic stage ≥T3 disease as determined by a ≥75% probability of extracapsular extension or seminal vesicle invasion per reading radiologist

Must not have

Specific inflammatory bowel diseases

Specific gastrointestinal conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether anti-testosterone drugs can stop prostate cancer from recurring after high-dose radiation therapy.

Who is the study for?

Men over 18 with advanced prostate cancer, not previously treated for it, can join this trial. They need a PSA level ≥20 ng/mL and clinical stage ≥T3 disease. Key organ functions must be normal, including liver and kidney tests. Participants should have no active infections like HIV or hepatitis that would make steroid use risky, no recent other cancer treatments or surgeries, and agree to use contraception during the study.

What is being tested?

The trial is testing if anti-testosterone drugs (Abiraterone and ARN-509) combined with Leuprolide and high-dose precision radiotherapy can prevent prostate cancer from returning. Patients will receive these medications before, during, and after the radiation treatment to see how effective they are together.

What are the potential side effects?

Possible side effects include hormonal changes due to testosterone suppression which may cause fatigue, hot flashes, sexual dysfunction; liver function changes; potential impact on heart rhythm; gastrointestinal issues affecting drug absorption; risk of seizures in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

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

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I am a man aged 18 or older.

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My cancer is advanced, with a high chance of spreading beyond its original location.

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My prostate cancer is aggressive (Gleason score 9-10 or >4 cores of Gleason 8).

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I am mostly able to care for myself.

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My prostate cancer is high-risk or has a Gleason score of 8-10.

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My prostate cancer diagnosis was confirmed with a tissue test.

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My prostate cancer is advanced, as confirmed by a physical exam.

Exclusion Criteria

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

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I have a specific type of inflammatory bowel disease.

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I have a specific condition affecting my digestive system.

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I have active symptoms of viral hepatitis or chronic liver disease.

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I have a stomach or intestine problem that affects how I absorb medications.

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My liver is severely damaged.

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I have seizures or conditions that could lead to seizures.

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I do not have uncontrolled diabetes, heart disease, or high blood pressure.

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I cannot undergo MRI or have markers placed in my body.

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I am not taking medication that strongly activates liver enzymes.

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I have not had major surgery in the last 4 weeks.

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My scans show I have at least one cancerous lymph node.

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I have had issues with my pituitary or adrenal glands.

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I do not have any infections or conditions that prevent me from taking prednisone.

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I do not have an active infection or a condition that prevents steroid use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

proportion of patients with biochemical failure

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: patients with prostate cancerExperimental Treatment4 Interventions

Eligible patients will receive a total of 6 months of leuprolide, abiraterone, and ARN-509 to begin three months prior to RT and continuing until approximately 3 months post-RT. Patients will be assessed every 4 weeks (±1 week) (a cycle = 28 days) throughout their treatment with the study drugs, and at least once during RT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone

2012

Completed Phase 4

~4480

ARN-509

2013

Completed Phase 2

~110