Abiraterone Acetate for Prostate Cancer

1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Prostate Cancer+7 More
Abiraterone Acetate - Drug
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether a combination of drugs may help slow the growth of prostate cancer.

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms
  • Carcinoma
  • refractory, metastatic hormone-refractory Prostate cancer
  • Adenocarcinoma, Prostate
  • Stage IV Prostate Cancer AJCC v8
  • Prostate Carcinoma Metastatic in the Bone
  • Stage IVA Prostate Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Abiraterone Acetate will improve 1 primary outcome and 5 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of Time from starting treatment until progression, assessed up to 6 months.

Month 6
Progression free survival (PFS)
Up to 6 months
Efficacy assessed
Expression of candidate markers
Incidence of adverse events
Time on treatment
up to 6 months
Overall survival

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Treatment (abiraterone acetate, prednisone, apalutamide)

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Abiraterone Acetate is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (abiraterone acetate, prednisone, apalutamide)Patient receive abiraterone acetate PO daily, prednisone PO BID, and apalutamide PO daily. Cycles repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
FDA approved
Apalutamide
FDA approved
Prednisone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The presence of measurable visceral metastasis on computed tomography (CT) or magnetic resonance imaging (MRI) is defined as the presence of one or more lesions that are 10 mm or greater in size. show original
The person has a performance status of 2 or less according to the Eastern Cooperative Oncology Group. show original
People who take medications that can lower their seizure threshold must stop taking them four weeks before they enter the study. show original
A blood test result of "absolute neutrophil count (ANC) >= 1,500/mm^3" means that the number of neutrophils in the blood is greater than or equal to 1,500 per millimeter cubed. show original
The Gleason score of >= 8 means that the cancer is very aggressive. show original
is suggestive of multiple myeloma If you have three or more lesions on your bone scan, it is likely that you have multiple myeloma. show original
The text states that Hemoglobin levels of 9.0 g/dL or above, regardless of whether or not transfusions or growth factors were used within the previous three months, is an eligibility requirement for enrolment in the study. show original
The patient's platelet count must be at least 100,000/uL, regardless of whether they have received a transfusion or growth factors in the previous three months. show original
without evidence of metastasis This is a cancer of the prostate that has been confirmed by looking at a sample of the tumor under a microscope show original
The serum albumin level is at or above 3.0 grams/deciliter. show original

Patient Q&A Section

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

What is the survival rate for prostate cancer?

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The survival rate is in range for prostate cancer, which may vary depending on stage at diagnosis. Survival rate is lower in the United States than in the developed and developing countries.

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How many people get prostate cancer a year in the United States?

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More than 250,000 men become prostate cancer survivors in a year, and approximately 18,000 men die of prostate cancer each year. Men who survive prostate cancer have a 30% chance of dying of prostate cancer. The American men with prostate cancer have an average survival of 6 years.

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What is prostate cancer?

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Prostate cancer is a cancer that forms in the prostate and typically forms in men over the age of 50. It is frequently painful and often appears as an enlargement of the prostate gland. Prostatitis, a chronic inflammation of the prostate gland, is not the same disease, but the terms are often used interchangeably. Prostatitis is a noncancerous disorder that can cause persistent and chronic inflammation. It often begins as an acute, noncancerous inflammation, generally caused by a viral infection or bacterial infection. Prostatitis may progress to cancer in 10-15% of cases.

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What causes prostate cancer?

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What causes [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) is not completely understood, but many factors have been identified that can affect the risk of getting this cancer, especially with African-American men, including exposure to pesticides, a family history of prostate cancer, a history of diabetes, and obesity. Some environmental and lifestyle factors that are thought to increase risk include drinking alcohol, increased body size, physical activity, and exposure to high-risk sexual behaviors. Genetic and racial differences in prostate cancer are also well-documented and may play an important role.

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What are common treatments for prostate cancer?

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There is no cure for prostate cancer, so treatment is most often focused on symptom management and is highly dependent on the specific patient. A number of treatments (such as hormonal therapy and chemotherapy) are used as part of the treatment.

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What are the signs of prostate cancer?

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Although most signs and symptoms appear as part and only after diagnosis of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), a few may be present before diagnosis, for example bleeding from the prostate, constipation or weakness. Abnormal sensations such as burning with urination, painful or sudden urination after having gone a while without feeling anything, decreased sex drive, or nocturia are also part of the prostate cancer diagnosis. Other symptoms that may warrant discussion with a doctor include unexplained weight loss and sudden muscle pain. Some symptoms such as changes in vision can be part of more serious conditions with similar symptoms – so-called 'false negatives' – that may have contributed to the diagnosis of prostate cancer.

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Can prostate cancer be cured?

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Prostatic cancer has not been definitely cured. However, with good and aggressive treatment, symptoms of prostatic cancer can be controlled and mortality from prostate cancer can be reduced.

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What does abiraterone acetate usually treat?

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The common side effects of AA administration can be avoided by regular clinical practice. In conclusion, with proper adjustment of the initial dose of AA the most common, non-severe side effects may be treated with only a small adjustment. However, the dose adjustment would not diminish the therapeutic effect of the drug. We conclude that AA can be used as an alternative therapy for hormone refractory prostate cancer.

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What is the primary cause of prostate cancer?

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Based on the results of this study, it can be concluded that [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) can not only be explained by some type of infection or exposure to an environmental factor. The study proposes another explanation of prostate cancer: the theory of the environmental component hypothesis (ECHP). The ECHP postulates that prostate development can be influenced by a variety of factors. In the case of prostate cancer, it seems reasonable to postulate that the most powerful carcinogenic factor is the exposure to tobacco. However, prostate cancer is a complex disease with a complex etiology, and other environmental factors are not completely excluded in causation. The main task of the researchers was the evaluation of the relationship of prostate cancer with other diseases.

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What are the latest developments in abiraterone acetate for therapeutic use?

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The safety profile of the standard 25 mg/week dose was excellent and there was a good tolerability profile with good or very good scores on most of the items across all the clinical events evaluated. In one clinical scenario, dose escalation to 50 mg/week did not influence the tolerability profile, with similar scores across all clinical events evaluated as for the 25 mg standard dose.

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What is abiraterone acetate?

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There are no randomized, controlled clinical trials currently available comparing the efficacy and safety of abiraterone acetate treatment with or without 5-alpha-reductase inhibitors in Japanese patients. Therefore, the therapeutic efficacy of the drug in this patient group has not yet been established. Future global randomized, controlled clinical trials are required to provide important information for Japanese patients.

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Does prostate cancer run in families?

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Although a substantial portion of both relatives in the families examined exhibited PCa in either the first or second degree, the prevalence of PCa was not higher in the family members. Furthermore, all of the men in the families with reported PCa had a family history of PCa and/or a PCa family history. Therefore, hereditary contribution to PCa appears to be low.

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