Therapy Pathways in the Treatment of Hormone Naïve Prostate Cancer Patients With and Without Comorbidities Treated With Degarelix or Luteinizing-Hormone-Releasing-Hormone (LHRH) Agonists.

Completed

• Conditions: Advanced Prostate Cancer
• Interventions: Drug: LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat); Drug: Degarelix

• Registration Number: NCT02234089
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-20
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-09
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 461

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LHRH agonist	LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat)	-
Degarelix	Degarelix	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Investigational site (there may be other sites in this country); 🇩🇪 Rottweil, Germany