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Prostate CancerPhase 2NCT00819156

Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

A Phase 2 study testing degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 39 sites in 8 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

The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. 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
189 participants
Where
39 sitesin 8 countries
Study dates
Feb 2004to Sep 2005
Phase
Phase 2
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

  • Written informed consent prior to any study related procedures
  • Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy
  • ECOG score to be equal to or above 2
  • Testosterone level within age-specific normal range
  • PSA value equal to or above 2 ng/ml
  • Life expectancy of at least 6 months

Who cannot join

  • Previous or current hormonal treatment of prostate cancer
  • Recent or current treatment with any drugs modifying the testosterone level
  • Candidate for curative treatment such as prostatectomy or radiotherapy
  • History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema
  • Hypersensitivity towards any component of degarelix or mannitol
  • Cancer disease within the last 5 years except for prostate cancer and some skin cancers
Show all 13Show fewer
  • Signs of liver impairment shown as elevated serum ALT or serum bilirubin
  • Known hepatic disease
  • Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
  • Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
  • Mental incapacity or language barrier precluding adequate understanding or cooperation
  • Having received an investigational product within the last 12 weeks preceding the trial
  • Previous participation in this trial

Trial locations and contacts

39 sites in 8 countries.

39 sites in 8 countries

Russia13 sites

  • Botkin Clinical Hospital

    Moscow

  • City Hospital #1

    Moscow

  • City Hospital #29

    Moscow

  • City Hospital #50

    Moscow

  • City Hospital #60

    Moscow

  • Institute of Urology of MoH

    Moscow

  • "Andros" Urology Clinic

    Saint Petersburg

  • City Hospital #15

    Saint Petersburg

  • City Hospital #26

    Saint Petersburg

  • Military Medical Academy, Urology

    Saint Petersburg

  • Pavlov Medical School Outpatient

    Saint Petersburg

  • Pavlov medical School, Urology

    Saint Petersburg

  • Sct Petersburg State Medical Academy

    Saint Petersburg

Other trials in Russia

Hungary6 sites

  • Bajcsy-Zsilinszky Hospital, Urology

    Budapest

  • Jahn Ferenc Dél Pesti Hospital, Urology

    Budapest

  • Pez Aladar County Hospital

    Győr

  • BAZ County Hospital

    Miskolc

  • Hospital of Local Gov. Szeged, Urology

    Szeged

  • MÁV Hospital, Urology

    Szolnok

Other trials in Hungary

South Africa5 sites

  • 370 Clarke Road

    Glenwood, Durban

  • Pretoria Urology Hospital

    Hatfield, Pretoria

  • WITS Medical School

    Parktown

  • 401B Medical Centre

    Pietermaritzburg

  • Sunninghill Clinic

    Sunninghill

Other trials in South Africa

Germany4 sites

  • Vivantes Klinikum am Urban

    Berlin

  • Loretto Krankenhaus

    Freiburg im Breisgau

  • Euromed AG Klinik

    Fürth

  • Urologische Universitätsklinikum

    Mannheim

Other trials in Germany

Romania4 sites

  • CF2 Hospital

    Bucharest

  • Dr. Th Burghele Hospital

    Bucharest

  • Fundeni Hospital

    Bucharest

  • Sf. Ioan Hospital

    Bucharest

Other trials in Romania

Belgium3 sites

  • UCL Saint Luc

    Brussels

  • UZ Gent

    Ghent

  • UZ Gasthuisberg

    Leuven

Other trials in Belgium

Netherlands2 sites

  • AMC

    Amsterdam

  • Atrium MC

    Heerlen

Other trials in Netherlands

Poland2 sites

  • Wojewódzki Szpital Specjalisttyczny

    Siedlce

  • Wojewódzki Szpital Specjalisttyczny

    Słupsk

Other trials in Poland

About this study

Official title: An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months

The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.

Read the detailed description

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Conditions
Prostate Cancer
Being tested
degarelix
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 FE200486

    Degarelix was given as subcutaneous injections.

Study groups in NCT00819156
Study groupRoleWhat they receive
Degarelix 200/80ExperimentalCycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Receives: Drug: degarelix
Degarelix 200/120ExperimentalCycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Receives: Drug: degarelix
Degarelix 200/160ExperimentalCycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Receives: Drug: degarelix
Degarelix 240/80ExperimentalCycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Receives: Drug: degarelix
Degarelix 240/120ExperimentalCycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Receives: Drug: degarelix
Degarelix 240/160ExperimentalCycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Receives: Drug: degarelix

What is being measured

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

  1. Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364

    Number of patients who achieved a testosterone level considered a castration level.

    Measured: 12 months

Secondary outcomes (13)

  1. Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28

    Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.

    Measured: Day 28 - 364

  2. Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.

    The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.

    Measured: Day 28

  3. Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.

    The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.

    Measured: Day 3

  4. Days to 50 Percent Reduction in Prostate-Specific Antigen

    Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.

    Measured: Day 0 (post dose) to Day 364

  5. Days to 90 Percent Reduction in Prostate-Specific Antigen

    Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.

    Measured: Day 0 (post dose) to Day 364

  6. Days to Prostate-Specific Antigen Progression

    Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.

    Measured: Day 0 (post dose) to Day 364

  7. Median Serum Testosterone Levels

    Measured: Day 0 (Baseline), Days 1,3,7,14, and 364

  8. Median Prostate-specific Antigen Levels

    Measured: Day 0 (Baseline), Days 3, 7, 14, and 364

  9. Median Values of Di-Hydrotestosterone

    Measured: Day 0 (Baseline), Days 1, 3, 7, 14, and 364

  10. Median Values for Serum Luteinizing Hormone

    Measured: Day 0 (Baseline), Days 1, 3, 7, 14, and 364

  11. Median Values for Follicle Stimulation Hormone

    Measured: Day 0 (Baseline), Days 1, 3, 7, 14, and 364

  12. The Number of Patients With Abnormal Liver Function Tests

    The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.

    Measured: 364 days

  13. The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight

    Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.

    Measured: Day 364

Timeline

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

  1. First posted8 Jan 2009 (estimated)
  2. Study startFeb 2004
  3. Primary completionJun 2005
  4. Study completionSep 2005

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00819156
Sponsor's protocol ID
FE200486 CS12
Status last verified
Dec 2011
First submitted
7 Jan 2009
Last updated
30 Nov 2023
Data monitoring committee
Yes

Publications

  • Van Poppel H, Tombal B, de la Rosette JJ, Persson BE, Jensen JK, Kold Olesen T. Degarelix: a novel gonadotropin-releasing hormone (GnRH) receptor blocker--results from a 1-yr, multicentre, randomised, phase 2 dosage-finding study in the treatment of prostate cancer. Eur Urol. 2008 Oct;54(4):805-13. doi: 10.1016/j.eururo.2008.04.065. Epub 2008 May 8.

    PubMed 18538469

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 39 sites in 8 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 6 inclusion and 13 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Russia, Hungary, South Africa, Germany, Romania and 3 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 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.

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 31 Mar 2009). 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?

Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 (time frame: 12 months). 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 NCT00819156, which also lists 1 linked publication.

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 30 Nov 2023.

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