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

NCT05612841 | Unknown

• 1 other identifier: 2021/660
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Total number of drug interactions per patient

  18 months

• 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

Study Arms (2)

non metastatic castration resistant prostate cancer

Other: data collection

metastatic castrare naïve prostate cancer

Other: data collection

Interventions

data collection OTHER

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

metastatic castrare naïve prostate cancer; non metastatic castration resistant prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Elise ROBERT

CONTACT

+33381668166; e1robert@chu-besancon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: November 10, 2022
• Study Start: April 5, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)