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Trial · Observational

CompletedPhase not statedRegistry data

Treatment of Prostate Cancer With Firmagon®

NCTNCT01710098 (opens ClinicalTrials.gov in a new tab)Other idUCM12-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
100 participants (actual)
Sponsor
United Clinic Management GmbH · Industry
Design
Not stated
Countries
1 country

Germany

Start
Jun 2012
Primary completion
Jun 2014
Completion
24 Sept 2015
First posted
18 Oct 2012 (estimated)
Last update posted
13 Apr 2020
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122013201420152016
  1. Ph –

    Treatment of Prostate Cancer With Firmagon®

    NCT01710098

    Jun 2012 to 24 Sept 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DegarelixDrug

Arms1

  • Other

    Degarelix

    adult male patients with advanced hormone dependent prostate cancer who receive 240 mg as a start dose and then monthly 80mg Firmagon® for one year

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. PSA-/Testosterone Level

    Time frame · 12 months

Secondary outcomes(2)

  1. S3 Guideline

    Time frame · 12 months

    Registry description

    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

    Registry description

    Anxiety score

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

24 results

The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer.

Klotz et al. 2008BJU internationalcited by 402

PMID 19035858DOI 10.1111/j.1464-410x.2008.08183.xPUB-19035858

Full text at the publisher24 results
Publisher pageSee results (24)

More studies

1 study on this page

PubMed tag: none · 2010

Testosterone levels in patients with metastatic prostate cancer treated with luteinizing hormone-releasing hormone therapy: prognostic significance?

Perachino et al. 2010BJU internationalcited by 103

PMID 19747358DOI 10.1111/j.1464-410x.2009.08814.xPUB-19747358

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 95 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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