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Steroidogenesis Inhibitor

Abiraterone Acetate for Prostate Cancer

Phase 2
Waitlist Available
Led By Mary-Ellen Taplin, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up imaging was performed every 12 weeks up to 23 months.
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a new way to give abiraterone acetate (a cancer drug) to see if it is safe and effective. It is also looking at why the drug stops working for some people.

Who is the study for?
This trial is for men over 18 with advanced prostate cancer that's resistant to hormone therapy and hasn't spread to the brain. They must have tried other treatments, stopped them at least 4 weeks ago, and still show signs of disease progression. Participants need good heart health, controlled blood pressure without too many medications, normal organ function, no major surgeries or therapies within the last month, and can't be on long-term steroids.
What is being tested?
The study tests if taking abiraterone acetate alone until worsening disease or toxicity symptoms is as safe and effective as taking it with prednisone from the start. It also explores why patients stop responding by analyzing blood and tissue samples.
What are the potential side effects?
Abiraterone acetate may cause high blood pressure, upset stomach, joint swelling or discomfort; liver function changes; increased cholesterol levels; low potassium in the blood; urinary tract infection; or an irregular heartbeat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~imaging was performed every 12 weeks up to 23 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and imaging was performed every 12 weeks up to 23 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
Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess
Secondary study objectives
Changes in BMI Between Cycle 1 and Next Cycle
Changes in Hemoglobin-A1c Between Cycle 1 and Next Cycle (Cycle 4)
Changes in Serum Concentrations of ACTH Between Cycle 1 and Cycle 2.
+11 more

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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 acetateExperimental Treatment1 Intervention
Participants will be treated with four 250 mg tablets (1,000 mg) of abiraterone acetate (AA) orally on 28-day cycles. For participants who experience persistent or severe mineralocorticoid excess or have PSA progression, prednisone 5 mg by mouth twice daily will be added. Patients will be treated until radiographic disease progression and unacceptable AE or taken off study for other reason.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
FDA approved

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,177 Total Patients Enrolled
77 Trials studying Prostate Cancer
15,789 Patients Enrolled for Prostate Cancer
Janssen Research & Development, LLCIndustry Sponsor
1,004 Previous Clinical Trials
6,402,747 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,178 Patients Enrolled for Prostate Cancer
Mary-Ellen Taplin, MDPrincipal InvestigatorDana-Farber Cancer Institute
15 Previous Clinical Trials
944 Total Patients Enrolled
14 Trials studying Prostate Cancer
877 Patients Enrolled for Prostate Cancer
~5 spots leftby Nov 2025
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