Study on How Abiraterone Affects Oxycodone in Men with Prostate Cancer

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Deventer Ziekenhuis Deventer The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.07.2023

Trial locations

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.

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.

Trial ID:
2023-505705-17-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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