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Prostate CancerPhase 2/3NCT00215683

An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer

A Phase 2/3 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 34 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Degarelix
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
34 sitesin 7 countries
Study dates
Feb 2005to Nov 2009
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Had given written consent before any study-related activity was performed (a study-related activity was defined as any procedure that would not have been performed during the normal management of the participant)
  • Had completed the FE200486 CS12 study

Who cannot join

  • Had been withdrawn from the FE200486 CS12 study

Trial locations and contacts

34 sites in 7 countries.

34 sites in 7 countries

Russia11 sites

  • Moscow State University of Medicine and Dentistry, Department of Urology, Urogynecology and Andrology, City Hospital #50, Urology Department

    Moscow

  • Russian Medical Academy of Postgraduate Education, Department of Gerontolology and Geriatrics, Moscow City Hospital #60, Urology Department, 84/1, Entuziastov Shosse (Hospital)

    Moscow

  • Russian Medical Academy of Postgraduate Education, Urology Department, Moscow Clinical Hospital n.a. Botkin, Urology Department, 5/16, 2-oy Botkinsky proezd (Hospital)

    Moscow

  • Russian State Medical University, Department of Urology and Surgical Nephrology, Moscow City Hospital #1

    Moscow

  • "Andros" Urology Clinic, 36A, Lenina St.

    Saint Petersburg, 197136

  • City Hospital #15, Urology Department

    Saint Petersburg

  • City Hospital #26, Urology Department

    Saint Petersburg

  • I.I. Mechnikov St. Petersburg State Medical Academy, Urology Department

    Saint Petersburg

  • Research Institute of Urology of the Ministry of Healthcare of the Russian Federation

    Saint Petersburg

  • St. Petersburg Pavlov Medical School, Urology Department

    Saint Petersburg

  • St.Petersburg Pavlov Medical School, Outpatient Diagnostic Center

    Saint Petersburg

Other trials in Russia

Hungary7 sites

  • Bajcsy-Zsilinszky Hospital, of local Government of Budapest, Dept. of Urology

    Budapest

  • Jahn Ferenc Dél-Pesti Hospital, Dept. of Urology

    Budapest

  • Pez Aladar County Hospital, Dept. of Urology

    Győr

  • Bács-Kiskun County Hospital, Dept. of Urology

    Kecskemét

  • BAZ County Hospital, Dept of Urology

    Miskolc

  • Hospital of Local Government of Szeged, Dept. of Urology

    Szeged

  • MÁV Hospital, Dept. of Urology

    Szolnok

Other trials in Hungary

South Africa5 sites

  • Glenwood Hospital

    Durban

  • WITS Medical School, Level 9

    Parktown

  • 401 B Medical Centre

    Pietermaritzburg

  • Pretoria Urology Hospital, Suite 2, Hatfield

    Pretoria

  • Sunninghill Clinic, Suite 3

    Sunninghill

Other trials in South Africa

Romania4 sites

  • "Prof.Dr.Th.Burghele" Hospital - Bucharest

    Bucharest

  • "Sf. Ioan" Emergency Hospital - Urology Department

    Bucharest

  • CF2 Hospital - Bucharest, Urology Department

    Bucharest

  • Fundeni Clinical Institute - Bucharest, Urology Department

    Bucharest

Other trials in Romania

Belgium3 sites

  • UCL Saint Luc

    Brussels

  • UZ Gent

    Ghent

  • UZ Gasthuisberg, Urology Department

    Leuven

Other trials in Belgium

Germany2 sites

  • Vivantes Klinikum am Urban, Klinik für Urologie

    Berlin

  • Urologische Universitätsklinikum, Klinikum Mannheim GmbH, Fakultät für Klinische Medizin Mannheim

    Mannheim

Other trials in Germany

Netherlands2 sites

  • Academic Medical Center, Dept. of Urology

    Amsterdam

  • Atrium MC, Dept. of Urology

    Heerlen

Other trials in Netherlands

About this study

Official title: An Open-Label, Multi-Centre, Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer.

This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.

The study was terminated when all ongoing participants had been treated for at least 5 years (including one year in the main study).

Read the detailed description

Participants who completed the main FE200486 CS12 study initially continued with the same dose in the FE200486 CS12A extension study. After a protocol amendment all study participants were treated with 160 mg (40 mg/mL).

The data include data from the participants who participated in both the main study (FE200486 CS12; NCT00819156) and the extension study FE200486 CS12A.

Conditions
Prostate Cancer
Being tested
Degarelix
Keywords
Prostate Cancer, Androgen ablation therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DegarelixDrug

    Also called Degarelix acetate, FE200486

    Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.

Study groups in NCT00215683
Study groupRoleWhat they receive
Degarelix 80 mgExperimentalParticipants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Receives: Drug: Degarelix
Degarelix 120 mgExperimentalParticipants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Receives: Drug: Degarelix
Degarelix 160 mgExperimentalParticipants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Receives: Drug: Degarelix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants With Markedly Abnormal Change in Vital Signs and Body Weight

    Vital signs and body weight included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.

    Measured: 5 years

  2. Liver Function Tests

    The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionOct 2009
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00215683
Sponsor's protocol ID
FE200486 CS12A
Status last verified
Mar 2015
First submitted
20 Sep 2005
Last updated
1 Apr 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 34 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Russia, Hungary, South Africa, Romania, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With Markedly Abnormal Change in Vital Signs and Body Weight (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00215683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.

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