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NCT Number: NCT04823910

Personalizing Docetaxel Dosing in Advanced Prostate Cancer

Patients with advanced prostate cancer are often treated with the chemotherapy drug docetaxel. The manufacturers of this drug suggest using the same dose of drug per m² body surface area for all patients. However we know that individuals end up with more or less of the drug circulating in their blood even after they have been given the same dose.

A software program (a "Dosing Tool") has been developed to provide information to doctors on how docetaxel will affect individual patients. The program may help doctors to make informed decisions about exactly how much drug to give to different people.

The purpose of the PARTNER study is to gather information from blood tests on patients being treated with docetaxel to help in the further development of the Dosing Tool. Some of these blood tests would have been taken anyway as part of patients' routine treatment. Others are extra for this study. Apart from the additional blood tests, everyone who enters the study is treated just as they would normally be if they were not taking part in the study.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Portsmouth Hospitals University NHS Trust

Portsmouth, PO6 3LY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with metastatic prostate cancer (hormone sensitive or castrate resistant) and histologically confirmed
  • Metastatic at disease onset or relapsed disease
  • A treatment decision has been made to start a course of docetaxel as part of their standard of care treatment in accordance with the drug's label and the treating clinician's judgement
  • Patient has not received a previous cycle of docetaxel within 8 weeks of the date of enrolment
  • Life expectancy > 12 weeks
  • Participant is willing and able to give informed consent for participation in the study

Exclusion criteria

  • Patients with autoimmune disease receiving active treatments Participant is unable to give informed consent

Treatment and study plan

Primary outcomes

  1. Measured vs predicted absolute neutrophil count over time between weeks three and six of docetaxel treatment

    Time frame: The tool will be used to predict the level of neutropenia between the second and third doses of docetaxel (so between weeks three and six of treatment)

Sponsors and collaborators

Lead sponsor

Physiomics

Industry

Collaborators

  • National Institute for Health Research, United Kingdom
  • Portsmouth Hospitals NHS Trust

Registry information

Acronym: PARTNER

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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