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OpenTrials
Completed

NCT Number: NCT01710098

Treatment of Prostate Cancer With Firmagon®

How are testosterone levels of patients with prostate cancer under treatment with Firmagon® changing.

Former studies showed a quick fall of testosterone levels after start of therapy with Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this in a normal outpatient urologist setting. Furthermore data is collected to prove the adherence to the German S3-Guideline for the treatment of prostate cancer.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–95 year

Sex eligibility

Male

Study type

Observational

Primary location

UCM GmbH

Planegg, Bavaria, 82152, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • advanced hormone-dependent prostate cancer with no other previous hormone therapy for whom - irrespectively of this NIS -the use of Firmagon® is intended

Exclusion criteria

  • contraindication for Degarelix

Treatment and study plan

degarelix

Drug

subcutaneous injection

Other names: Firmagon®

Primary outcomes

  1. PSA-/Testosterone Level

    Time frame: 12 months

Secondary outcomes

  1. S3 Guideline

    Time frame: 12 months

    Percentage of patients who have been treated in accordance with the grade A recommendations of the S3 guideline for treatment of prostate cancer

  2. Anxiety

    Time frame: 12 Months

    Anxiety score

Sponsors and collaborators

Lead sponsor

United Clinic Management GmbH

Industry

Registry information

Official study title

Effectiveness and Safety as Well as Adherence of the "S3 Guidelines for the Treatment of Prostate Cancer" in the Treatment of Patients of Patients With Firmagon®

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Oct 18, 2012
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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