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

Recruiting

• Conditions: Prostatic Neoplasm
• Interventions: Other: data collection

• Registration Number: NCT05612841
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Study Start: 2022-04-05
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Study First Posted: 2022-11-10
• Last Update Posted: 2022-11-10
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 264

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non metastatic castration resistant prostate cancer	data collection	-
metastatic castrare naïve prostate cancer	data collection	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Description of the rate of patients with prostate cancer presenting a significant comorbidity according to investigator in a real life setting	18 months
Total number of drug interactions per patient	18 months	Hatoum scale: level 1 to level 4
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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Besançon; 🇫🇷 Besançon, France