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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

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 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
8%
Abdominal Pain
8%
Stomatitis
8%
Oedema Peripheral
8%
Urinary Tract Infection
8%
Arthralgia
7%
Cancer Pain
6%
Leukopenia
6%
Pain
6%
Pyrexia
6%
Polyneuropathy
6%
Dyspnoea
6%
Alopecia
6%
Neuropathy Peripheral
5%
Pain In Extremity
4%
Weight Decreased
4%
Hypokalaemia
4%
Hypertension
3%
Febrile Neutropenia
3%
Disease Progression
3%
Bone Pain
3%
Spinal Cord Compression
3%
Pneumonia
2%
Atrial Fibrillation
2%
Acute Kidney Injury
2%
Sepsis
1%
Femoral Neck Fracture
1%
Rectal Haemorrhage
1%
Malaise
1%
Gamma-Glutamyltransferase Increased
1%
Vertigo
1%
Inflammation
1%
Atrial Flutter
1%
Neutropenic Infection
1%
Pathological Fracture
1%
Tumour Pain
1%
Loss Of Consciousness
1%
Diarrhoea Haemorrhagic
1%
General Physical Health Deterioration
1%
Gastroenteritis
1%
Platelet Count Decreased
1%
Flank Pain
1%
Spinal Pain
1%
Oncologic Complication
1%
Transient Ischaemic Attack
1%
Hydronephrosis
1%
Aspiration
1%
Urinary Retention
1%
Hepatitis
1%
Toxicity To Various Agents
1%
Alanine Aminotransferase Increased
1%
Pancytopenia
1%
Neuroendocrine Carcinoma Of The Skin
1%
Carotid Artery Stenosis
1%
Syncope
1%
Haemoptysis
1%
Septic Shock
1%
Device Related Sepsis
1%
Laryngeal Inflammation
1%
Perineal Cellulitis
1%
Urosepsis
1%
Head Injury
1%
Cognitive Disorder
1%
Aspartate Aminotransferase Increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabazitaxel
Enzalutamide or Abiraterone

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

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
395 Previous Clinical Trials
265,033 Total Patients Enrolled
26 Trials studying Prostate Cancer
53,509 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,959 Total Patients Enrolled
566 Trials studying Prostate Cancer
529,768 Patients Enrolled for Prostate Cancer
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,146 Total Patients Enrolled
26 Trials studying Prostate Cancer
53,509 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone Acetate (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT01309672 — Phase 2
Prostate Cancer Research Study Groups: Abiraterone acetate + prednisone
Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT01309672 — Phase 2
Abiraterone Acetate (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01309672 — Phase 2
~3 spots leftby Sep 2025
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