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ProComD: 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.

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02234089
Collaborator
(none)
461
Enrollment
1
Location
57.9
Actual Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Degarelix
  • Drug: LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat)

Study Design

Study Type:
Observational
Actual Enrollment :
461 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Actual Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Jun 30, 2019
Actual Study Completion Date :
Jun 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Degarelix

Drug: Degarelix
According to medical practice
Other Names:
  • Firmagon®

    		•
    LHRH agonist

    Drug: LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat)
    According to medical practice

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational site (there may be other sites in this country) Rottweil Germany

    Sponsors and Collaborators

    • Ferring Pharmaceuticals

    Investigators

    • Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ferring Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02234089
    Other Study ID Numbers:
    • 000156
    First Posted:
    Sep 9, 2014
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jul 1, 2019
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jul 5, 2019