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Antiandrogen

abiraterone acetate 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients With Undetectable PSA
Secondary outcome measures
Number of Patients With PSA Partial Response
Number of Patients With Toxicity of Abiraterone Acetate
Objective Progression-free Survival
+1 more

Side effects data

From 2021 Phase 4 trial • 255 Patients • NCT02485691
22%
Back Pain
21%
Asthenia
21%
Nausea
17%
Fatigue
16%
Arthralgia
15%
Decreased Appetite
11%
Anaemia
11%
Vomiting
10%
Pain In Extremity
10%
Constipation
9%
Oedema Peripheral
7%
Cancer Pain
6%
Weight Decreased
6%
Bone Pain
6%
Pyrexia
6%
Diarrhoea
6%
Disease Progression
6%
Hypertension
6%
Hypokalaemia
5%
Pain
4%
Haematuria
4%
Dysgeusia
3%
Acute Kidney Injury
3%
Urinary Tract Infection
2%
Atrioventricular Block Complete
2%
Renal Failure
2%
General Physical Health Deterioration
2%
Neuropathy Peripheral
2%
Dehydration
2%
Dyspnoea
2%
Abdominal Pain
2%
Upper Gastrointestinal Haemorrhage
2%
Spinal Cord Compression
2%
Stomatitis
2%
Urinary Tract Obstruction
2%
Cardiac Failure
1%
Erysipelas
1%
Enterobacter Sepsis
1%
Urinary Retention
1%
Urinary Tract Infection Bacterial
1%
Hydronephrosis
1%
Device Dislocation
1%
Pelvic Pain
1%
Pleural Effusion
1%
Neutropenia
1%
Leukopenia
1%
Lymphoedema
1%
Ileus Paralytic
1%
Hypocalcaemia
1%
Pneumonia
1%
Pulmonary Sepsis
1%
Tooth Infection
1%
Hyperfibrinolysis
1%
Thrombocytopenia
1%
Acute Coronary Syndrome
1%
Cerebral Haemorrhage
1%
Paraparesis
1%
Chronic Obstructive Pulmonary Disease
1%
Pulmonary Embolism
1%
Angina Pectoris
1%
Duodenal Ulcer
1%
Proctalgia
1%
Spinal Compression Fracture
1%
Pyelocaliectasis
1%
Oncologic Complication
1%
Pathological Fracture
1%
Hypertensive Crisis
1%
Herpes Zoster
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enzalutamide or Abiraterone
Cabazitaxel

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
~2370

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,569 Total Patients Enrolled
26 Trials studying Prostate Cancer
53,509 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,605 Total Patients Enrolled
559 Trials studying Prostate Cancer
507,113 Patients Enrolled for Prostate Cancer
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
262,210 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there availability to partake in this medical research?

"Unfortunately, this medical trial is no longer recruiting new candidates. It was initially posted on August 9th 2011 and the last update was on November 30th 2022. For individuals looking for other trials related to prostate cancer, 1321 studies are currently enrolling while 366 clinical trials are actively searching for patients who would respond well to abiraterone acetate treatment."

Answered by AI

How many participants have enrolled in this research project?

"This trial is not currently accepting new candidates. It was initially posted on August 9, 2011 and most recently amended on November 30th 2022. If you are interested in alternative studies, there are presently 1321 clinical trials actively enrolling individuals with prostate cancer and 366 studies for abiraterone acetate seeking participants."

Answered by AI

How many research sites are facilitating this investigation?

"Currently, this clinical trial is welcoming enrollees from 100 sites including Maywood, Overland Park and Montrose. To minimize travel burdens for participants it may be beneficial to select a site location as close by as possible."

Answered by AI

Has abiraterone acetate been granted regulatory clearance by the FDA?

"Our team has assessed the safety of abiraterone acetate to be a 2, as this is still in Phase 2. This means there are some findings that support its security but no data verifying effectiveness yet."

Answered by AI

Have there been any prior experiments involving abiraterone acetate?

"Presently, 366 clinical trials associated with abiraterone acetate are in progress. Of those active studies, 100 have progressed to the third stage of development. While a majority of these investigations are based out of Duarte, California, 17 421 sites across the globe are conducting research on this treatment modality."

Answered by AI

Does this research trial have an age restriction?

"The age range for participation in this trial has been set between 18 and 120, according to the inclusion criteria."

Answered by AI

What health conditions is abiraterone acetate commonly utilized to combat?

"Abiraterone acetate is typically used to treat thyroiditis but can be employed for other illnesses, such as varicella-zoster virus acute retinal necrosis, malignant neoplasms, and ulcerative colitis."

Answered by AI

What criteria must a participant fulfill for eligibility in this experiment?

"Currently, a total of 41 patients suffering from prostate cancer aged between 18 and 120 are in search of enrolment for this trial. To be eligible to participate, they must meet the following qualifications: confirmation that their tumours have spread to either their axial or appendicular skeleton; evidence-based diagnosis of adenocarcinoma of the prostate; presence of metastases in other visceral organs such as the liver or lungs; having undergone bilateral surgical orchiectomy if applicable; plus distant lymph node disease above the aortic bifurcation (or similar)."

Answered by AI
~3 spots leftby Mar 2025