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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 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

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

40%

Diarrhoea

30%

Anaemia

29%

Fatigue

26%

Asthenia

23%

Nausea

22%

Neutropenia

16%

Back Pain

15%

Constipation

14%

Haematuria

13%

Decreased Appetite

13%

Vomiting

12%

Dysgeusia

Arthralgia

Urinary Tract Infection

Oedema Peripheral

Abdominal Pain

Stomatitis

Cancer Pain

Pain

Leukopenia

Dyspnoea

Polyneuropathy

Alopecia

Pyrexia

Neuropathy Peripheral

Pain In Extremity

Hypokalaemia

Weight Decreased

Hypertension

Febrile Neutropenia

Disease Progression

Bone Pain

Spinal Cord Compression

Pneumonia

Atrial Fibrillation

Acute Kidney Injury

Sepsis

Hydronephrosis

Atrial Flutter

Rectal Haemorrhage

Vertigo

Spinal Pain

Aspiration

Flank Pain

Transient Ischaemic Attack

Urinary Retention

General Physical Health Deterioration

Inflammation

Femoral Neck Fracture

Oncologic Complication

Gastroenteritis

Pathological Fracture

Neutropenic Infection

Loss Of Consciousness

Gamma-Glutamyltransferase Increased

Tumour Pain

Platelet Count Decreased

Diarrhoea Haemorrhagic

Malaise

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

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

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

SWOG Cancer Research NetworkLead Sponsor

394 Previous Clinical Trials

264,579 Total Patients Enrolled

26 Trials studying Prostate Cancer

53,509 Patients Enrolled for Prostate Cancer

National Cancer Institute (NCI)NIH

13,708 Previous Clinical Trials

40,932,688 Total Patients Enrolled

563 Trials studying Prostate Cancer

509,023 Patients Enrolled for Prostate Cancer

Southwest Oncology GroupLead Sponsor

388 Previous Clinical Trials

261,220 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

Recent research and studies

clinicaltrials.govStudy

S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy

2011. "S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01309672.

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