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.

Advanced Prostate Cancer Clinical Trial

— ProComD  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234089
• Other study ID #: 000156
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Advanced Prostate Cancer
• Prostatic Neoplasms

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