Prostatic Neoplasm
Conditions
Brief 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.
Interventions
OTHERdata collection
data collection from drug-drug interaction between anti-cancer treatment and and other medications
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients with a non metastatic castration-resistant or a metastatic castrate naïve prostate cancer with at least one significant drug interaction. | 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of drug interactions per patient | 18 months | Hatoum scale: level 1 to level 4 |
| Description of the rate of patients with prostate cancer presenting a significant comorbidity according to investigator in a real life setting | 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 | 18 months | assessed either by the Micromedex software or the national thesaurus of the ANSM |
Countries
France
Contacts
Primary ContactElise ROBERT
Outcome results
None listed