Personalizing Docetaxel Dosing in Advanced Prostate Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04823910

Acronym

PARTNER

Enrollment

Registered

2021-04-01

Start date

2021-07-06

Completion date

2022-12-31

Last updated

2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Measured vs predicted absolute neutrophil count over time between weeks three and six of docetaxel treatment	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)

Countries

United Kingdom

Outcome results