Prostate CancerPARTNERNCT04823910
Personalizing Docetaxel Dosing in Advanced Prostate Cancer
An observational study of Prostate Cancer, run by Physiomics at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jul 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Any patient with metastatic prostate cancer due to start treatment with docetaxel
Who may be able to join
- 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
Who cannot join
- Patients with autoimmune disease receiving active treatments Participant is unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals University NHS Trust
Portsmouth, PO6 3LY
About this study
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.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured vs predicted absolute neutrophil count over time between weeks three and six of docetaxel treatment
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start6 Jul 2021
- Primary completion30 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physiomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Portsmouth Hospitals NHS Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823910
- Sponsor's protocol ID
- PHT/2020/41
- Acronym
- PARTNER
- Status last verified
- Mar 2023
- First submitted
- 23 Mar 2021
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing Docetaxel Dosing in Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT04823910
- Acronym / sponsor ID
- PARTNER / PHT/2020/41
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PhysiomicsIndustry (pharma, biotech, devices)
- Collaborators
- Portsmouth Hospitals NHS Trust, National Institute for Health Research, United Kingdom
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with metastatic prostate cancer due to start treatment with docetaxel
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with autoimmune disease receiving active treatments Participant is unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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The COSMYC Trial (COmbined Suppression of MYC)
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Not yet recruitingPhase 3
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Prostatic Neoplasms
RecruitingPhase 1/2
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RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
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RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Physiomics at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.