Prostatic NeoplasmIN-PROVENCT05612841
A Study on Drug-drug Interactions in Patients Treated With Anticancer Agents for a Prostate Cancer in Real Life Setting
An observational study of Prostatic Neoplasm, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This will be a national observational, non-randomised, multicentre study, conducted in France. Patients will be recruited in routine clinical practice by office- or hospital-based urology and/or oncology specialists when a first line treatment for their castrate resistant prostate cancer is initiated. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- data collection
- How many people
- 264 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2022to Oct 2023
- 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: Patients with a non metastatic castration-resistant or a metastatic castrate naïve prostate cancer, with a minimum of 100 patients with a non metastatic castrate-resistant prostate cancer.
- Males aged ≥18 years;
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
- For patients with a nmCRPC, documented castration resistance with progression of prostate cancer on androgen deprivation therapy (ADT) (surgical or chemical);
- Initiation of first- line systemic therapy (with abiraterone, apalutamide, darolutamide, docetaxel or enzalutamide) for a non metastatic castrate-resistant or a metastatic castrate naïve prostate cancer according to the approved labels and current guidelines. The metastatic status is based on conventional imaging (CT scan, bone scan).
Patients are not eligible if they are receiving an investigational treatment for prostate cancer of any kind.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Besançon
Besançon
Antoine Thiery-Vuillemin, MD
About this study
Official title: A Study on Drug-drug Interactions in Patients Treated With Anticancer Agents for a Non Metastatic Castrate-resistant Prostate Cancer or a Metastatic Castrate naïve Prostate Cancer in Real Life Setting
This will be a national observational, non-randomised, multicentre study, conducted in France.
Patients will be recruited in routine clinical practice by office- or hospital-based urology and/or oncology specialists when a first line treatment for their castrate resistant prostate cancer is initiated. The decision to treat patients with either agent preceding study enrolment will be left to the investigator's decision, per routine clinical practice. The nature of treatment and clinical care of patients will not be influenced by their participation in the study. All patients meeting the study criteria who visit the study physician will be consecutively invited to participate in the study to minimise recruitment bias. All medications administered will be collected. This is a non-interventional study. The investigators are free to choose products, and modalities of administration in accordance with the local Summary of Product Characteristics Therefore, the decision to prescribe one of these therapies must be made prior to and independently from the decision to enrol patients in this non interventional study.
Read more
Potential DDI will be identified using electronic screening methods (Micromedex Software and Theriaque Software).
This design will enable assessment of treatment and subsequent outcomes based on local standards, and is likely to encompass a wider range of therapeutic decisions compared with the stricter, defined limits on therapy required by investigational study protocols. Decisions and outcomes made in real-world conditions are likely to be more widely applicable to clinical practice than those from interventional studies.
Following French regulation there is no need for an approval of ethic committee for this type of observational study.
- Conditions
- Prostatic Neoplasm
- Being tested
- data collection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
data collection from drug-drug interaction between anti-cancer treatment and and other medications
| Study group | Role | What they receive |
|---|---|---|
| non metastatic castration resistant prostate cancer | Not described Receives: Other: data collection | |
| metastatic castrare naïve prostate cancer | Not described Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with a non metastatic castration-resistant or a metastatic castrate naïve prostate cancer with at least one significant drug interaction.
Measured: 18 months
Secondary outcomes (3)
Total number of drug interactions per patient
Hatoum scale: level 1 to level 4
Measured: 18 months
Description of the rate of patients with prostate cancer presenting a significant comorbidity according to investigator in a real life setting
Measured: 18 months
Exploratory assessment of baseline clinical (e.g. age, comorbidities, stage of cancer, ECOG) or biological (e.g. CBC, liver tests, PSA, albumin) parameters that may be link to a higher risk of drug interaction
assessed either by the Micromedex software or the national thesaurus of the ANSM
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start5 Apr 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612841
- Sponsor's protocol ID
- 2021/660
- Acronym
- IN-PROVE
- Status last verified
- Nov 2022
- First submitted
- 23 Feb 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Drug-drug Interactions in Patients Treated With Anticancer Agents for a Non Metastatic Castrate-resistant Prostate Cancer or a Metastatic Castrate naïve Prostate Cancer in Real Life Setting
- ClinicalTrials.gov ID
- NCT05612841
- Acronym / sponsor ID
- IN-PROVE / 2021/660
- Conditions
- Prostatic Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 10 Nov 2022 (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.
This will be a national observational, non-randomised, multicentre study, conducted in France.
Patients will be recruited in routine clinical practice by office- or hospital-based urology and/or oncology specialists when a first line treatment for their castrate resistant prostate cancer is initiated. The decision to treat patients with either agent preceding study enrolment will be left to the investigator's decision, per routine clinical practice. The nature of treatment and clinical care of patients will not be influenced by their participation in the study. All patients meeting the study criteria who visit the study physician will be consecutively invited to participate in the study to minimise recruitment bias. All medications administered will be collected. This is a non-interventional study. The investigators are free to choose products, and modalities of administration in accordance with the local Summary of Product Characteristics Therefore, the decision to prescribe one of these therapies must be made prior to and independently from the decision to enrol patients in this non interventional study.
Potential DDI will be identified using electronic screening methods (Micromedex Software and Theriaque Software).
This design will enable assessment of treatment and subsequent outcomes based on local standards, and is likely to encompass a wider range of therapeutic decisions compared with the stricter, defined limits on therapy required by investigational study protocols. Decisions and outcomes made in real-world conditions are likely to be more widely applicable to clinical practice than those from interventional studies.
Following French regulation there is no need for an approval of ethic committee for this type of observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non metastatic castration resistant prostate cancer | – | Other: data collection |
| metastatic castrare naïve prostate cancer | – | Other: data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a non metastatic castration-resistant or a metastatic castrate naïve prostate cancer, with a minimum of 100 patients with a non metastatic castrate-resistant prostate cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collectiondata collection from drug-drug interaction between anti-cancer treatment and and other medications | Other | metastatic castrare naïve prostate cancer, non metastatic castration resistant prostate cancer |
Primary outcome
Rate of patients with a non metastatic castration-resistant or a metastatic castrate naïve prostate cancer with at least one significant drug interaction.
Time frame: 18 months
3 secondary outcomes
Total number of drug interactions per patient
Time frame: 18 months
Description of the rate of patients with prostate cancer presenting a significant comorbidity according to investigator in a real life setting
Time frame: 18 months
Exploratory assessment of baseline clinical (e.g. age, comorbidities, stage of cancer, ECOG) or biological (e.g. CBC, liver tests, PSA, albumin) parameters that may be link to a higher risk of drug interaction
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No
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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.
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 Prostatic Neoplasm, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 10 Nov 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elise ROBERT (+33381668166, e1robert@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with a non metastatic castration-resistant or a metastatic castrate naïve prostate cancer with at least one significant drug interaction. (time frame: 18 months). 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 10 Nov 2022.