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Trial Title:
A Study on Drug-drug Interactions in Patients Treated With Anticancer Agents for a Prostate Cancer in Real Life Setting
NCT ID:
NCT05612841
Condition:
Prostatic Neoplasm
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
data collection
Description:
data collection from drug-drug interaction between anti-cancer treatment and and other
medications
Arm group label:
metastatic castrare naïve prostate cancer
Arm group label:
non metastatic castration resistant prostate cancer
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. 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
- 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Hospitalier Universitaire de Besançon
Address:
City:
Besançon
Country:
France
Status:
Recruiting
Contact:
Last name:
Antoine Thiery-Vuillemin, MD
Start date:
April 5, 2022
Completion date:
October 2023
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Besancon
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Besancon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05612841
