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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months after treatment
Awards & highlights

Study 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.Check my eligibility
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).See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prostate-Specific Antigen

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
Leuprolide Acetate
2002
Completed Phase 3
~1890
Flutamide
2013
Completed Phase 4
~1980
Prednisone
2014
Completed Phase 4
~2370
Nilutamide
1996
Completed Phase 3
~310
Abiraterone Acetate
2015
Completed Phase 4
~1880
Bicalutamide
2003
Completed Phase 3
~5330
Degarelix
2002
Completed Phase 3
~3600

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,204 Total Patients Enrolled
Christopher LogothetisPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Prostate Adenocarcinoma Research Study Groups: Arm A (finite androgen ablation), Arm B (finite androgen ablation, abiraterone, prednisone)
~17 spots leftby Feb 2025
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