Personalizing Docetaxel Dosing in Advanced Prostate Cancer (PARTNER)

March 8, 2023 updated by: Physiomics

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Portsmouth, United Kingdom, PO6 3LY
        • Portsmouth Hospitals University NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Any patient with metastatic prostate cancer due to start treatment with docetaxel

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Physiomics

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 23, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHT/2020/41

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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