Personalizing Docetaxel Dosing in Advanced Prostate Cancer

Prostate Cancer Clinical Trial

— PARTNER  

Official title:

Personalizing Docetaxel Dosing in Advanced Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04823910
• Other study ID #: PHT/2020/41
• Status: Completed
• Start date: July 6, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Physiomics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals University NHS Trust	Portsmouth

Sponsors (3)

Lead Sponsor	Collaborator
Physiomics	National Institute for Health Research, United Kingdom, Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)