NCT01710098

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2015

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

October 10, 2012

Last Update Submit

April 9, 2020

Conditions

Prostate Cancer

Keywords

testosteroneS3-AdherenceQuality of Life

Outcome Measures

Primary Outcomes (1)

  • PSA-/Testosterone Level

    12 months

Secondary Outcomes (2)

  • S3 Guideline

    12 months

  • Anxiety

    12 Months

Study Arms (1)

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

Drug: Degarelix

Interventions

DegarelixDRUG

subcutaneous injection

Also known as: Firmagon®
Degarelix

Eligibility Criteria

Age18 Years - 95 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult male patients of outpatient urological medical practice

You may qualify if:

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

You may not qualify if:

  • contraindication for Degarelix

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCM GmbH

Planegg, Bavaria, 82152, Germany

Location

Related Publications (7)

  • Thompson IM, Zeidman EJ, Rodriguez FR. Sudden death due to disease flare with luteinizing hormone-releasing hormone agonist therapy for carcinoma of the prostate. J Urol. 1990 Dec;144(6):1479-80. doi: 10.1016/s0022-5347(17)39774-4.

    PMID: 2122011BACKGROUND

  • Klotz L, Boccon-Gibod L, Shore ND, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder FH. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU Int. 2008 Dec;102(11):1531-8. doi: 10.1111/j.1464-410X.2008.08183.x.

    PMID: 19035858BACKGROUND

  • Morote J, Orsola A, Planas J, Trilla E, Raventos CX, Cecchini L, Catalan R. Redefining clinically significant castration levels in patients with prostate cancer receiving continuous androgen deprivation therapy. J Urol. 2007 Oct;178(4 Pt 1):1290-5. doi: 10.1016/j.juro.2007.05.129. Epub 2007 Aug 14.

    PMID: 17698136BACKGROUND

  • Perachino M, Cavalli V, Bravi F. Testosterone levels in patients with metastatic prostate cancer treated with luteinizing hormone-releasing hormone therapy: prognostic significance? BJU Int. 2010 Mar;105(5):648-51. doi: 10.1111/j.1464-410X.2009.08814.x. Epub 2009 Aug 28.

    PMID: 19747358BACKGROUND

  • Mariani S, Salvatori L, Basciani S, Arizzi M, Franco G, Petrangeli E, Spera G, Gnessi L. Expression and cellular localization of follicle-stimulating hormone receptor in normal human prostate, benign prostatic hyperplasia and prostate cancer. J Urol. 2006 Jun;175(6):2072-7; discussion 2077. doi: 10.1016/S0022-5347(06)00273-4.

    PMID: 16697805BACKGROUND

  • Radu A, Pichon C, Camparo P, Antoine M, Allory Y, Couvelard A, Fromont G, Hai MT, Ghinea N. Expression of follicle-stimulating hormone receptor in tumor blood vessels. N Engl J Med. 2010 Oct 21;363(17):1621-30. doi: 10.1056/NEJMoa1001283.

    PMID: 20961245BACKGROUND

  • Heidenreich A., Epplen R., Thüer D., Van Erps T., D.P., EURO Prostate Center. EAU guideline on advanced prostate cancer: Compliance among urologists conderning androgen deprivation therapy

    BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

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

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Leopold Durner, MD

    UCM GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Study Group

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 18, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

September 24, 2015

Last Updated

April 13, 2020

Record last verified: 2020-04

Locations

DE(1)