Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients

NCT01793077 | Completed

• 1 other identifier: BE-11-EGD-04
• Study Type: observational
• Target: 259
• Locations: 1 country
• Sites: 23

Brief Summary

Tremodi is an observational, non-interventional, prospective, open-label, non-comparative study that will collect real life data of a treatment with Depo-Eligard® in 3 different administrations in male prostate cancer patients. Once the examining physician has decided on the therapeutic approach and if the selection criteria are fulfilled, he will propose the patient to participate in the study. An informed consent form will be collected for all participants in the study. There are 2 possible study visits that coincide with a routine consultation, namely visit 1 (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining physician will give a global evaluation of the treatment with Depo-Eligard® and assesses the treatment benefit of the patient. Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both visits, if available.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Phase 4; Data collection; Observational; Depo-Eligard; Prospective; Non-interventional; Treatment

Outcome Measures

Primary Outcomes (1)

• Evaluation of tolerability of treatment on a 4 point scale

  Last Visit (after at least 180 days of treatment)

Secondary Outcomes (6)

• Occurrence of Adverse Drug Reactions

  Day 1 and Last Visit (after at least 180 days of treatment)

• Investigator satisfaction with treatment

  Last Visit (after at least 180 days of treatment)

• Overall patient's assessment of treatment benefit

  Last Visit (after at least 180 days of treatment)

• Changes in quality of life of subjects as measured by EORTC QLQ-C30

  Day 1 and Last Visit (after at least 180 days of treatment)

• Frequency of use of dosing schedules of Depo-Eligard® and the reasons for selecting a schedule

  Day 1 and Last Visit (after at least 180 days of treatment)

Study Arms (1)

Prostate Cancer patients

Drug: Depo-Eligard®

Interventions

Depo-Eligard® DRUG

Subcutaneous

Also known as: Leuprolide Acetate

Prostate Cancer patients

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consultation at urology department

You may qualify if:

• Patients having been prescribed Depo-Eligard® 7.5 mg - 22.5 mg - 45 mg in accordance with the terms of the marketing authorization.

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead
• Veeda Clinical Research: collaborator

Study Sites (23)

Site: 5

Antwerp, Antwerp, 2018, Belgium

Location

Site: 8

Antwerp, Antwerp, 2018, Belgium

Location

Site: 9

Antwerp, Antwerp, 2018, Belgium

Location

Site: 14

Antwerp, Antwerp, 2020, Belgium

Location

Site: 4

Antwerp, Antwerp, 2200, Belgium

Location

Site: 33

Merksem, Antwerp, 2170, Belgium

Location

Site: 1

Turnhout, Antwerp, 2300, Belgium

Location

Site: 23

Brussels, Brussels Capital, 1030, Belgium

Location

Site: 13

Brussels, Brussels Capital, 1090, Belgium

Location

Site: 24

Uccle, Brussels Capital, 1180, Belgium

Location

Site: 32

Aalst, East Flanders, 9300, Belgium

Location

Site: 34

Dendermonde, East Flanders, 9200, Belgium

Location

Site: 11

Ghent, East Flanders, 9000, Belgium

Location

Site: 17

Oudenaarde, East Flanders, 9700, Belgium

Location

Site: 18

Tienen, Flemish Brabant, 3300, Belgium

Location

Site: 39

La Louvière, Hainaut, 7100, Belgium

Location

Site: 37

Sint-Truiden, Limburg, 3800, Belgium

Location

Site: 38

Liège, Liège, 4000, Belgium

Location

Site: 26

Lasne-Chapelle-Saint-Lambert, Walloon Brabant, 1380, Belgium

Location

Site: 21

Ieper, West Flanders, 8900, Belgium

Location

Site: 20

Izegem, West Flanders, 8870, Belgium

Location

Site: 25

Kortijk, West Flanders, 8500, Belgium

Location

Site: 31

Ostend, West Flanders, 8400, Belgium

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide

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)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Medical Director

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 15, 2013
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

BE (23)