A Study on Drug-drug Interactions in Patients Treated With Anticancer Agents for a Prostate Cancer in Real Life Setting

NCT ID: NCT05612841

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 264 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-05
• Study Completion Date: 2023-10-31

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.

Conditions

Prostatic Neoplasm

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

non metastatic castration resistant prostate cancer

data collection

Intervention Type: OTHER

data collection from drug-drug interaction between anti-cancer treatment and and other medications

metastatic castrare naïve prostate cancer

data collection

Intervention Type: OTHER

data collection from drug-drug interaction between anti-cancer treatment and and other medications

Interventions

data collection

data collection from drug-drug interaction between anti-cancer treatment and and other medications

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire de Besançon

Besançon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Elise ROBERT

Role: CONTACT

e1robert@chu-besancon.fr

+33381668166

Facility Contacts

Antoine Thiery-Vuillemin, MD

Role: primary

Other Identifiers

2021/660

Identifier Type: -

Identifier Source: org_study_id