Clinical trial NCT01793077: 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
Official title: Phase IV, Non-interventional, Prospective, Open Label, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Phase 4
Data collection
Observational
Depo-Eligard
Prospective
Non-interventional
Treatment
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Veeda Clinical Research
First posted: 2013-02-15
Enrollment: 259
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consultation at urology department

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Evaluation of tolerability of treatment on a 4 point scale
timeFrame: Last Visit (after at least 180 days of treatment)
Secondary outcomes:
measure: Occurrence of Adverse Drug Reactions
timeFrame: Day 1 and Last Visit (after at least 180 days of treatment)
measure: Investigator satisfaction with treatment
timeFrame: Last Visit (after at least 180 days of treatment)
measure: Overall patient's assessment of treatment benefit
timeFrame: Last Visit (after at least 180 days of treatment)
measure: Changes in quality of life of subjects as measured by EORTC QLQ-C30
timeFrame: Day 1 and Last Visit (after at least 180 days of treatment)
measure: Frequency of use of dosing schedules of Depo-Eligard® and the reasons for selecting a schedule
timeFrame: Day 1 and Last Visit (after at least 180 days of treatment)
measure: Efficacy of treatment
timeFrame: Day 1 and Last Visit (after at least 180 days of treatment)
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Site: 5
state: Antwerp
city: Antwerpen
country: Belgium
facility: Site: 8
state: Antwerp
city: Antwerpen
country: Belgium
facility: Site: 9
state: Antwerp
city: Antwerpen
country: Belgium
facility: Site: 14
state: Antwerp
city: Antwerpen
country: Belgium
facility: Site: 4
state: Antwerp
city: Merksem
country: Belgium
facility: Site: 33
state: Antwerp
city: Turnhout
country: Belgium
facility: Site: 1
state: Antwerp
city: Brussel
country: Belgium
facility: Site: 13
state: Brussels Capital Region
city: Bruxelles
country: Belgium
facility: Site: 23
state: Brussels Capital Region
city: Uccle
country: Belgium
facility: Site: 24
state: Brussels Capital Region
city: Aalst
country: Belgium
facility: Site: 32
state: East Flanders
city: Dendermonde
country: Belgium
facility: Site: 34
state: East Flanders
city: Gent
country: Belgium
facility: Site: 11
state: East Flanders
city: Oudenaarde
country: Belgium
facility: Site: 17
state: East Flanders
city: Tienen
country: Belgium
facility: Site: 18
state: Flemish Brabant
city: La Louvière
country: Belgium
facility: Site: 39
state: Hainaut
city: Sint Truiden
country: Belgium
facility: Site: 37
state: Limburg
city: Lasne Chapelle Saint Lambert
country: Belgium
facility: Site: 26
state: Walloon Brabant
city: Ieper
country: Belgium
facility: Site: 21
state: West Flanders
city: Izegem
country: Belgium
facility: Site: 20
state: West Flanders
city: Kortijk
country: Belgium
facility: Site: 25
state: West Flanders
city: Oostende
country: Belgium
facility: Site: 31
state: West Flanders
city: Liège
country: Belgium
facility: Site: 38
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Medical Director
role: STUDY_DIRECTOR
References: