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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02234089
Acronym
ProComD
Enrollment
461
Registered
2014-09-09
Start date
2014-09-30
Completion date
2019-06-30
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Prostate Cancer

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).

Interventions

DRUGDegarelix

According to medical practice

DRUGLHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat)

According to medical practice

Sponsors

Ferring Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
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

Design outcomes

Primary

MeasureTime frameDescription
Level of urologist's knowledge of patients' medical history at the point of decision making and during Androgen Deprivation Therapy (ADT)Up to 4 yearsMeasured 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 ADTUp to 4 yearsMeasured 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 ADTUp to 4 yearsMeasured 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 ADTUp to 4 yearsMeasured by questionnaires by quantifying the frequency of urologists' entries

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026