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Antiandrogen

Abiraterone + Prednisone for Prostate Cancer

Phase 2

Waitlist Available

Led By Thomas W. Flaig, MD

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

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

Must have

No patients with active or symptomatic viral hepatitis, chronic liver disease, moderate or severe hepatic impairment, or history of NYHA class III or IV heart failure

No concurrent medications that may interact with study drugs

Must not have

No medications that alter cardiac conduction

No prior or concurrent cytotoxic chemotherapy or radiopharmaceuticals for prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying abiraterone acetate to see if it can help treat patients with prostate cancer who have undergone initial hormone therapy.

Who is the study for?

Men with advanced prostate cancer who have had hormone therapy but haven't responded well. They should not have brain metastases, severe liver disease, or heart failure. Participants need to be able to swallow pills whole and must agree to use birth control if necessary.

What is being tested?

The trial is testing the effectiveness of abiraterone acetate in men whose prostate cancer hasn't responded adequately to initial hormone therapy. The drug aims to reduce androgen production which may slow tumor growth.

What are the potential side effects?

Possible side effects include fatigue, joint swelling or discomfort, hot flushes, diarrhea, vomiting, coughing, high blood pressure, shortness of breath, urinary tract infection and anemia.

Eligibility Criteria

Inclusion Criteria

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

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I don't have active hepatitis, severe liver issues, or serious heart failure.

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I am not taking any medications that could affect the study drugs.

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My prostate cancer diagnosis was confirmed through a tissue test.

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My overall health, blood, kidney, liver, and hormone levels meet the trial's requirements.

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My blood pressure is under control.

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I do not have stomach or bowel problems that affect how I absorb medicine.

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My cancer has spread to other parts of my body and I am starting hormone therapy.

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I am currently on hormone therapy for my cancer.

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I have had both testicles surgically removed.

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My PSA levels did not drop enough with hormone therapy.

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I have never had brain cancer spread.

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I can swallow pills without needing to break them down.

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My cancer has spread to either my organs, bones, or distant lymph nodes.

Exclusion Criteria

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

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I am not taking any heart rhythm altering medications.

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I have not had chemotherapy or radiopharmaceuticals for prostate cancer.

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I have not used ketoconazole for prostate cancer.

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I am not taking any hormone-related medications.

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I have never received Provenge treatment.

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I am not planning to undergo chemotherapy, immunotherapy, surgery, or radiotherapy while on the trial treatment.

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I am not taking any antifungal medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Number of Patients With Undetectable PSA

Secondary study objectives

Number of Patients With PSA Partial Response

Number of Patients With Toxicity of Abiraterone Acetate

Objective Progression-free Survival

Side effects data

From 2021 Phase 4 trial • 255 Patients • NCT02485691

40%

Diarrhoea

30%

Anaemia

29%

Fatigue

26%

Asthenia

23%

Nausea

22%

Neutropenia

16%

Back Pain

15%

Constipation

14%

Haematuria

13%

Vomiting

13%

Decreased Appetite

12%

Dysgeusia

Abdominal Pain

Stomatitis

Oedema Peripheral

Urinary Tract Infection

Arthralgia

Cancer Pain

Leukopenia

Pain

Pyrexia

Polyneuropathy

Dyspnoea

Alopecia

Neuropathy Peripheral

Pain In Extremity

Weight Decreased

Hypokalaemia

Hypertension

Febrile Neutropenia

Disease Progression

Bone Pain

Spinal Cord Compression

Pneumonia

Atrial Fibrillation

Acute Kidney Injury

Sepsis

Femoral Neck Fracture

Rectal Haemorrhage

Malaise

Gamma-Glutamyltransferase Increased

Vertigo

Inflammation

Atrial Flutter

Neutropenic Infection

Pathological Fracture

Tumour Pain

Loss Of Consciousness

Diarrhoea Haemorrhagic

General Physical Health Deterioration

Gastroenteritis

Platelet Count Decreased

Flank Pain

Spinal Pain

Oncologic Complication

Transient Ischaemic Attack

Hydronephrosis

Aspiration

Urinary Retention

Hepatitis

Toxicity To Various Agents

Alanine Aminotransferase Increased

Pancytopenia

Neuroendocrine Carcinoma Of The Skin

Carotid Artery Stenosis

Syncope

Haemoptysis

Septic Shock

Device Related Sepsis

Laryngeal Inflammation

Perineal Cellulitis

Urosepsis

Head Injury

Cognitive Disorder

Aspartate Aminotransferase Increased

100%

80%

60%

40%

20%

Study treatment Arm

Cabazitaxel

Enzalutamide or Abiraterone

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: Abiraterone acetate + prednisoneExperimental Treatment2 Interventions

Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone, 5 mg, oral, 5 mg twice daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

abiraterone acetate

2017

Completed Phase 4

~920

Prednisone

2014

Completed Phase 4

~2500