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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02234089
Other study ID # 000156
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2014
Est. completion date June 30, 2019

Study information

Verified date July 2019
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to detect factors influencing decision making for treatment pathways of hormone-naïve prostate cancer patients with and without comorbidities receiving medicinal androgen deprivation therapy (Degarelix or LHRH agonists).


Recruitment information / eligibility

Status Completed
Enrollment 461
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosed with Prostate Cancer and indicated for ADT according to Summary of Product Characteristics (SmPC)

- Decision made to prescribe ADT (Degarelix or LHRH agonist) prior to enrolment

Exclusion Criteria:

- Patient had previous or is currently under hormonal management of Prostate Cancer, except for a curative intention, where the duration of the neoadjuvant/adjuvant therapy did not exceed 6 months and treatment should have been terminated at least 6 months prior to baseline.

- Participation in a clinical trial at baseline and during the follow-up period

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Degarelix
According to medical practice
LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat)
According to medical practice

Locations

Country Name City State
Germany Investigational site (there may be other sites in this country) Rottweil

Sponsors (1)

Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of urologist's knowledge of patients' medical history at the point of decision making and during Androgen Deprivation Therapy (ADT) Measured by questionnaires by quantifying the frequency of urologists' entries Up to 4 years
Primary Level of urologist's knowledge of patients' comorbidities at the point of decision making and during ADT Measured by questionnaires by quantifying the frequency of urologists' entries Up to 4 years
Primary Level of urologist's knowledge of patients' concomitant medications at the point of decision making and during ADT Measured by questionnaires by quantifying the frequency of urologists' entries Up to 4 years
Primary Level of urologist's knowledge of patients' risk factors at the point of decision making and during ADT Measured by questionnaires by quantifying the frequency of urologists' entries Up to 4 years
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