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Study on How Abiraterone Affects Oxycodone in Men with Prostate Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication abiraterone on the way the body processes another medication called oxycodone. The study involves men who have been diagnosed with prostate cancer. Some of these men are being treated with abiraterone, while others are not. Abiraterone is a medication commonly used to treat prostate cancer, and in this study, it is given at a dose of 1000 mg per day to those who are receiving it.

The purpose of the study is to understand how abiraterone affects the metabolism of oxycodone, which is a pain-relieving medication. Participants will receive a single dose of 15 mg of oxycodone in the form of a hard capsule. The study will compare the effects of oxycodone in men who are taking abiraterone with those who are not. This will help researchers learn more about how these medications interact in the body.

Throughout the study, participants will be monitored to see how their bodies process oxycodone. This involves measuring certain aspects of the medication in the body over time. The study aims to provide valuable information that could help improve the treatment of pain in patients with prostate cancer who are also taking abiraterone. Participants will be part of the study for a short period, and the research is expected to conclude by April 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be assigned to one of two groups. If you are already being treated with abiraterone, you will be in group 1. If you are not being treated with abiraterone, you will be in group 2.
Step 2
Abiraterone treatment (if applicable)
If you are in group 1, you will continue taking abiraterone at a dose of 1000 mg once daily. This treatment should have been ongoing for at least 10 days before the study begins.
Step 3
Oxycodone administration
You will receive a single dose of 15 mg of oxycodone in the form of a hard capsule. This medication is taken orally.
Step 4
Monitoring and data collection
After taking the oxycodone, your body's response to the medication will be monitored. This involves measuring how the medication is processed in your body over a period of time. The focus will be on understanding the levels of oxycodone in your system and how long it stays there.
Step 5
Completion of study participation
Once the monitoring period is complete, your participation in the study will end. The data collected will be used to understand the effect of abiraterone on the processing of oxycodone in the body.

Who can join the trial?

4 criteria

Must be a male aged 18 years or older.
Must have been diagnosed with prostate cancer.
If participating in arm 1 of the study, must be treated with abiraterone 1000 mg once daily for at least 10 days.
If participating in arm 2 of the study, must not be treated with abiraterone 1000 mg once daily for at least 10 days.

Who cannot join the trial?

5 criteria

Patients who are not males aged 18 years or older.
Patients who do not have prostate cancer.
Patients who are not being treated with abiraterone or are not in the group not receiving abiraterone.
Patients who are female.
Patients who are part of a vulnerable population, which means groups that might need special protection or care.

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Investigated drugs

Abiraterone
is a medication used to treat prostate cancer. It works by reducing the levels of certain hormones in the body that can promote the growth of cancer cells. In this clinical trial, researchers are studying how abiraterone affects the way the body processes another medication, oxycodone, in men with prostate cancer.
Oxycodone
is a medication used to relieve moderate to severe pain. It works by changing the way the brain and nervous system respond to pain. In this study, a single dose of oxycodone is given to participants to see how its breakdown and absorption in the body are influenced by the presence of abiraterone.

Oxycodone Hydrochloride

What is already known about the treatment

Abiraterone
Abiraterone is taken orally in the form of tablets, typically at a dose of 1000 mg per day, and is used to treat prostate cancer in men. It is well-established in medical literature as a treatment for prostate cancer, particularly in patients who have not responded to other therapies. Abiraterone works by blocking the production of androgens, which are hormones that can promote the growth of prostate cancer cells. It belongs to a class of drugs known as androgen biosynthesis inhibitors.
Oxycodone
Oxycodone is administered orally, often in tablet form, and is used to manage moderate to severe pain. In the context of this study, a single dose of 15 mg normal-release oxycodone is given to assess its interaction with abiraterone in men with prostate cancer. Oxycodone works by binding to opioid receptors in the brain and spinal cord, reducing the perception of pain. It is classified as an opioid analgesic.

Investigated diseases

Prostate Cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in males that produces seminal fluid. This cancer often grows slowly and may initially cause no symptoms. As it progresses, it can lead to difficulty urinating, blood in the urine, or pelvic discomfort. In some cases, it may spread to other parts of the body, such as the bones or lymph nodes. The progression can vary greatly among individuals, with some experiencing rapid growth and others having a more indolent course.