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Steroidogenesis Inhibitor

abiraterone acetate for Prostate Cancer

Q: How do doctors use ACTH and corticosteroid levels in the blood to diagnose patients?

<p>To diagnose and treat thyroiditis, <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a>, or malignant neoplasms, doctors can assess a patient's serum corticosteroid intermediates and ACTH levels.</p>

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ imaging was performed every 12 weeks up to 23 months.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess

Secondary outcome measures

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%

Decreased Appetite

13%

Vomiting

12%

Dysgeusia

Urinary Tract Infection

Arthralgia

Oedema Peripheral

Abdominal Pain

Stomatitis

Cancer Pain

Pain

Leukopenia

Dyspnoea

Alopecia

Polyneuropathy

Pyrexia

Neuropathy Peripheral

Pain In Extremity

Hypokalaemia

Weight Decreased

Hypertension

Disease Progression

Bone Pain

Febrile Neutropenia

Spinal Cord Compression

Pneumonia

Atrial Fibrillation

Acute Kidney Injury

Sepsis

Rectal Haemorrhage

Hydronephrosis

Atrial Flutter

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 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,078 Previous Clinical Trials

340,812 Total Patients Enrolled

77 Trials studying Prostate Cancer

16,105 Patients Enrolled for Prostate Cancer

Janssen Research & Development, LLCIndustry Sponsor

975 Previous Clinical Trials

6,384,248 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

Frequently Asked Questions

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

Across how many states is this research being conducted?

"8 medical facilities are participating in this research project, with locations spanning from Basking Ridge to Harrison. If you enroll, try and pick a clinic that is close to your home to minimize travel time."

Answered by AI

How do doctors use ACTH and corticosteroid levels in the blood to diagnose patients?

"To diagnose and treat thyroiditis, ulcerative colitis, or malignant neoplasms, doctors can assess a patient's serum corticosteroid intermediates and ACTH levels."

Answered by AI

Are there other investigations that measure both serum corticosteroid intermediates and ACTH?

"There are 378 ongoing clinical trials evaluating serum corticosteroid intermediates and ACTH. Out of these, 101 have reached Phase 3. Most studies for assessment of serum corticosteroid intermediates and ACTH are based in Duarte, California; however, there are 17174 locations running these types of trials globally."

Answered by AI

Are there any current vacancies for willing participants in this experiment?

"This study is no longer recruiting patients. According to the information available on clinicaltrials.gov, this trial was posted on 1/27/2014 and updated for the last time on 10/13/2022. There are 1296 other trials related to prostate cancer and 378 studies investigating serum corticosteroid intermediates and ACTH that are actively looking for participants."

Answered by AI

What risks are associated with measuring hormone levels in the blood?

"Although there is not yet data supporting the efficacy of this assessment, it has been determined to be safe and was given a score of 2."

Answered by AI

How many willing individuals are a part of this investigation?

"This study is not recruiting at this time. However, there are 1296 trials actively enrolling participants with prostate cancer and 378 trials for assessment of serum corticosteroid intermediates and ACTH that are."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer

Mary-Ellen Taplin, MD 2014. "Study of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02025010.

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