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Hormone Therapy

Androgen Ablation + Abiraterone/Prednisone for Prostate Cancer

Phase 2

Waitlist Available

Led By Christopher Logothetis

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Histologically documented diagnosis of adenocarcinoma of the prostate (PCa) with no histologic variants

Prostate cancer recurrence after definitive local therapy as evidenced by rising serum PSA without metastases

Must not have

Clinically significant heart disease

Prior therapy with specific agents not allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well finite androgen ablation with or without abiraterone acetate and prednisone works in treating patients with prostate cancer that has come back.

Who is the study for?

Men with recurrent prostate cancer after surgery or radiation, without metastases, are eligible for this trial. They must have a life expectancy of at least 12 months, be in good physical condition (ECOG <=2), and have rising PSA levels. Participants need normal blood counts and organ function tests, agree to use contraception if sexually active, and be able to take oral medication on an empty stomach.

What is being tested?

The study is testing the effectiveness of hormone therapy using drugs like leuprolide acetate against prostate cancer growth by lowering androgen levels. It's comparing standard treatment with additional abiraterone acetate (which decreases testosterone production) and prednisone (to reduce side effects).

What are the potential side effects?

Possible side effects include hot flashes, fatigue, joint pain from hormone therapy; liver issues from abiraterone; increased blood sugar or infections from prednisone; plus potential heart problems or allergic reactions related to the medications.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer is confirmed without any rare forms.

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My prostate cancer has returned, shown by increasing PSA levels, but hasn't spread.

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I've been on hormone therapy for prostate cancer for less than 8 weeks and my PSA levels are rising without any visible spread.

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I can swallow pills without any difficulty.

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I am willing to take abiraterone acetate without eating.

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I can take care of myself and perform daily activities.

Exclusion Criteria

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

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I have a serious heart condition.

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I have not been treated with certain specific drugs.

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I have stomach or intestine problems that affect how I absorb medications.

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I need long-term corticosteroids for a chronic condition.

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

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I have active or symptomatic viral hepatitis.

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I have had issues with my pituitary or adrenal glands.

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My cancer has spread to other parts of my body.

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (finite androgen ablation, abiraterone, prednisone)Experimental Treatment8 Interventions

Participants receive leuprolide acetate, goserelin acetate, degarelix, bicalutamide, flutamide, or nilutamide as in Arm A. Patients also receive abiraterone acetate PO daily for 8 months and prednisone daily. Patients may crossover to Arm A with disease progression after 8 months.

Group II: Arm A (finite androgen ablation)Active Control6 Interventions

Participants receive either leuprolide acetate via injection every month or every 4 months, goserelin acetate via injection every month, or degarelix via injection every month for 8 months. Patients also receive bicalutamide PO QD, flutamide PO TID, or nilutamide PO QD. Patients may crossover to Arm B with disease progression after 8 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Goserelin Acetate

2007

Completed Phase 3

~1040

Flutamide

2013

Completed Phase 4

~2110