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Hormone Therapy

Abiraterone + Prednisone vs Darolutamide for Prostate Cancer

Phase 2

Recruiting

Research Sponsored by Mamta Parikh

Eligibility Criteria Checklist

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

Must have

Performance status 0 - 2 (Karnofsky ≥ 50%)

Histologically confirmed prostate adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares abiraterone+prednisone vs darolutamide in advanced prostate cancer to see which has better side effects.

Who is the study for?

This trial is for men with advanced prostate cancer that has spread beyond the original site. Participants should not have had prior treatment with abiraterone, prednisone, or darolutamide. They must be able to provide tissue samples and willing to follow study procedures.

What is being tested?

The trial compares two treatments: one group receives abiraterone plus prednisone (standard care), while the other gets just darolutamide. The goal is to see which treatment better stops tumor growth by affecting male hormone levels or blocking their use by tumors.

What are the potential side effects?

Abiraterone can cause high blood pressure, heart issues, liver problems, and muscle pain. Prednisone may lead to weight gain, mood changes, increased infection risk, and bone thinning. Darolutamide might result in fatigue, nausea, and skin rash.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but may not be able to do active work.

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My prostate cancer was confirmed through a tissue examination.

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I can and will follow the study's schedule and rules.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 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

Incidence of grade 3 or higher adverse events

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

Group I: Arm II (darolutamide)Experimental Treatment2 Interventions

Patients receive darolutamide per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.

Group II: Arm I (abiraterone, prednisone)Experimental Treatment3 Interventions

Patients receive abiraterone and prednisone per SOC. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2500

Abiraterone

2012

Completed Phase 4

~4490