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Clinical Trials/NCT02234089
NCT02234089CompletedNot Applicable

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.

Ferring Pharmaceuticals1 site in 1 country461 target enrollmentStarted: September 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
461
Locations
1
Primary Endpoint
Level of urologist's knowledge of patients' medical history at the point of decision making and during Androgen Deprivation Therapy (ADT)

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
Male
Accepts Healthy Volunteers
No

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

Arms & Interventions

Degarelix

Intervention: Degarelix (Drug)

LHRH agonist

Intervention: LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat) (Drug)

Outcomes

Primary Outcomes

Level of urologist's knowledge of patients' medical history at the point of decision making and during Androgen Deprivation Therapy (ADT)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Up to 4 years

Measured by questionnaires by quantifying the frequency of urologists' entries

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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