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Prostate CancerPhase 2NCT00738673

Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer

A Phase 2 study testing degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 15 sites in Germany.

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 open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12 months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal treatment in Prostate Cancer patients who experienced PSA-Failure following gonadotropin-releasing hormone (GnRH) agonist treatment. 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
37 participants
Where
15 sitesGermany
Study dates
Jul 2008to Dec 2011
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

  • Patient has given written informed consent before any trial-related activity is performed.
  • Patient is 18 years or older.
  • Histologically confirmed prostate cancer.
  • Patient has received GnRH receptor agonist therapy for a duration of at least 12 months (the first dose of GnRH-antagonist is to be administered when the next dose of the GnRH-agonist would have been due).
  • Patient has experienced rising PSA levels although receiving GnRH agonist therapy, defined as two consecutive rises of PSA at least two weeks apart in two 50% increases over the nadir, and at least one PSA value of >2.5 ng/mL within the last six months.
  • Testosterone on castrate level (defined as ≤ 0.5 ng/mL) (cohort 1); Testosterone ≥0.2 ng/mL at inclusion (cohort 2)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Estimated life expectancy at least 12 months.

Who cannot join

  • Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
  • Ongoing GnRH agonist therapy (last dose of previous GnRH agonist must have been received before Visit 1).
  • Any pre-trial secondary hormonal manipulation (including antiandrogens) after PSA increase as described as above and before trial entry. Antiandrogens as part of complete androgen blockade must have been discontinued at least three months before first dose of trial medication.
  • Previous or current treatment with chemotherapy (e.g. estramustine) for prostate cancer.
  • Known hypersensitivity towards any component of the investigational medical product.
  • History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Show all 12Show fewer
  • Known or suspected clinically significant liver and/or biliary disease.
  • Any clinically significant laboratory abnormalities, disorders, or other condition, including alcohol or drug abuse, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
  • Patient has a clinically significant disorder (other than prostate cancer) including, but not limited to, renal, hematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
  • Patient has a mental incapacity or language barriers precluding adequate understanding or co-operation.
  • Patient has received an investigational drug within the last 28 days preceding screening visit. Or longer if considered to possibly influencing the outcome of the current trial.
  • Previous participation in any degarelix trial.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Germany15 sites

  • Urologische Praxis

    Bautzen

  • Urologische Klinik

    Berlin

  • Urologische Praxis

    Berlin

  • Urologische Praxis

    Borken

  • Urologische Praxis

    Cologne

  • Urologische Praxis

    Erkrath - Hochdal

  • Urologische Praxis

    Hagenow, 19230

  • Martini Klinik

    Hamburg

  • Urologische Praxis

    Husum

  • Urologische Praxis

    Kirchheim

  • Urologische Praxis

    Lauenburg/Elbe

  • Urologische Praxis

    Leipzig

  • Urologische Praxis

    Markkleeberg

  • Urologische Klinik

    Planegg

  • Wissenschaftskontor Nord

    Rostock

Other trials in Germany

About this study

Official title: An Open-Label, Multi-Centre, Uncontrolled, Exploratory Trial Investigating Degarelix One-Month Dosing Regimen as Second-Line Hormonal Treatment After PSA-Failure in GnRH Agonist Treated Patients With Prostate Cancer

This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12 months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal treatment in Prostate Cancer patients who experienced PSA-Failure following gonadotropin-releasing hormone (GnRH) agonist treatment. The two cohorts differ in Testosterone levels at inclusion.

Conditions
Prostate Cancer
Being tested
degarelix
Keywords
Hormone refractory prostate cancer, Agonist treatment failure
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

    Starting dose of 240 mg (40 mg/mL). Maintenance doses of 80 mg (20 mg/mL).

Study groups in NCT00738673
Study groupRoleWhat they receive
DegarelixExperimentalStarting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Receives: Drug: degarelix

What is being measured

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

  1. Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline

    Response to treatment was defined as:

    • Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
    • No response (increase): Difference > +10% of Baseline level

    Measured: Day 0 (baseline), 3 months

Secondary outcomes (11)

  1. Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline

    Response to treatment was defined as:

    • Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
    • No response (increase): Difference > +10% of Baseline level.

    Per protocol, the one month timeframe was only analyzed for cohort 2.

    Measured: Day 0 (baseline), 1 month

  2. Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline

    Response to treatment was defined as:

    • Response (stabilisation or decrease): Difference ≤ +10% of Baseline level
    • No response (increase): Difference > +10% of Baseline level.

    Per protocol, the two month timeframe was only analyzed for cohort 2.

    Measured: Day 0 (baseline), 2 months

  3. Participants at Testosterone Castrate Level Throughout the Study

    Participants who had no post-baseline serum testosterone level above castrate level which was <=0.5 ng/mL.

    Measured: up to month 12

  4. Change From Baseline in Serum Levels of Testosterone at the Last Visit

    Measured: Day 0 (baseline), up to month 12 (last visit)

  5. Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit

    Measured: Day 0 (baseline), up to month 12 (last visit)

  6. Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit

    LH is measured in IU/L

    Measured: Day 0 (baseline), up to month 12 (last visit)

  7. Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit

    Measured: Day 0 (baseline), up to month 12 (last visit)

  8. Participants at Testosterone Level <=0.2 ng/mL Throughout the Study

    Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.

    Measured: up to month 12

  9. Participants at Testosterone Level <=0.32 ng/mL Throughout the Study

    Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL

    Measured: up to month 12

  10. Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study

    Counts of participants who had PSA progression during the study. PSA progression was defined as PSA >+10% of baseline value.

    Measured: up to month 12

  11. Kaplan-Meier Estimate for Overall Survival

    The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient's data were censored at the date of last visit.

    Measured: up to month 12

Timeline

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

  1. First posted20 Aug 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionDec 2011
  4. Study completionDec 2011

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00738673
Sponsor's protocol ID
FE200486 CS27
Other IDs
2008-000585-22, 2008
Status last verified
Dec 2012
First submitted
18 Aug 2008
Last updated
18 Jan 2013
Data monitoring committee
No

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 15 sites in Germany.

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 8 inclusion and 12 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 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany. 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 18 Jan 2013). 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' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline (time frame: Day 0 (baseline), 3 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 NCT00738673.

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 18 Jan 2013; AzTrials last refreshed its copy on 6 Nov 2026.

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