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' 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' 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' 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