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.

NCT02234089 | Completed

• 1 other identifier: 000156
• Study Type: observational
• Target: 461
• Locations: 1 country
• Sites: 1

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).

Conditions

Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Degarelix

Drug: Degarelix

LHRH agonist

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

Interventions

Degarelix DRUG

According to medical practice

Also known as: Firmagon®

Degarelix

LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat) DRUG

According to medical practice

LHRH agonist

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced prostate cancer where a treatment decision on therapy has already been made according to medical practice.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Investigational site (there may be other sites in this country)

Rottweil, Germany

Location

Related Publications (1)

• Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

  PMID: 34350976 DERIVED

MeSH Terms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Gonadotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: September 9, 2014
• Study Start: September 1, 2014
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

DE (1)