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Prostate CancerPhase 2NCT00468286

Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

A Phase 2 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 29 sites in 5 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 study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of… 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
133 participants
Where
29 sitesin 5 countries
Study dates
May 2007to Aug 2008
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

  • Patients, aged 18 years or older, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
  • Screening testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL.
  • Eastern Cooperative Oncology Group (ECOG) score of ≤2.
  • Screening prostate-specific antigen (PSA) level ≥ ng/mL.

Who cannot join

None listed.

Trial locations and contacts

29 sites in 5 countries.

29 sites in 5 countries

United States11 sites

  • South Florida Medical Research

    Aventura, Florida, 33180

  • Investigational site

    Carmel, New York, 10512

  • The Urology Center

    Greensboro, North Carolina, 27403

  • Urology Centers of Alabama

    Homewood, Alabama, 35209

  • South Orange County Medical Research Center

    Laguna Woods, California, 92653

  • Grand Strand Urology

    Myrtle Beach, South Carolina, 29572

  • Urology of Virginia Research

    Norfolk, Virginia, 23502

  • Florida Foundation for Healthcare Research

    Ocala, Florida, 34474

  • Urology Research Center

    Seattle, Washington, 98166

  • Regional Urology

    Shreveport, Louisiana, 71106

  • State College Urologic Association

    State College, Pennsylvania, 16801

Other trials in United States

Romania7 sites

  • Private Medical Center

    Arad

  • "Prof Dr Th Burghele" Clinical Hospital

    Bucharest

  • Dinu Uromedica

    Bucharest

  • Fundeni Clinical Institute

    Bucharest

  • E-Uro Medical Center S.R.L.

    Cluj-Napoca

  • Provita Center

    Constanța

  • Sibiu County Clinical Hospital

    Sibiu

Other trials in Romania

Canada4 sites

  • Investigational site

    Kentville, Nova Scotia

  • The Female/Male Health Centres

    Ontario

  • Investigational site

    Surrey, British Columbia

  • Investigational site

    Victoria, British Columbia

Other trials in Canada

Hungary4 sites

  • Dombóvári Szent Lukács Egészségügyi Kht

    Dombóvár

  • Borsod-Abaúj-Zemplé n Megyei Kórház és Egyetemi Oktató Kórház

    Miskolc

  • Miskolc Megyei Jogú Város Önkormányzat Miskolci Egészségügyi Központ

    Miskolc

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

    Szeged

Other trials in Hungary

Czechia3 sites

  • Nemocnice Jindrichuv Hradec a.s.

    Hradec

  • Slezska nemocnice

    Opava

  • Vseobecna fakultni nemocnice v Praze

    Prague

Other trials in Czechia

About this study

Official title: An Open-Label, Multi-Centre, Randomised Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy

The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.

Read the detailed description

An Open-Label, Multi-Centre, Randomized Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients with Prostrate Cancer Requiring Androgen Ablation Therapy.

Conditions
Prostate Cancer
Being tested
Degarelix
Keywords
Prostate Cancer
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

    Experimental

    Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.

  • DegarelixDrug

    Experimental

    Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.

Study groups in NCT00468286
Study groupRoleWhat they receive
AExperimentalTreatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Receives: Drug: Degarelix
BExperimentalTreatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months.
Receives: Drug: Degarelix

What is being measured

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

  1. Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364

    Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 28 to Day 364.

    Measured: 1 year

Secondary outcomes (8)

  1. Serum Levels of Testosterone Over Time

    Measured: 1 year

  2. Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 56 Through Day 364

    Kaplan-Maier estimates of the cumulative probabilities of testosterone <=0.5 ng/mL from Day 56 to Day 364.

    Measured: 1 year

  3. Probability of no PSA Failure

    Cumulative probability (%) and 95% confidence interval (CI) for completing the study without PSA failure. PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (lowest level of PSA achieved).

    Measured: 1 year

  4. Serum Levels of PSA Over Time

    Measured: 1 year

  5. Serum Levels of Follicle Stimulating Hormone (FSH) Over Time

    Measured: 1 year

  6. Serum Levels of Luteinizing Hormone (LH) Over Time

    Measured: 1 year

  7. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

    This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.

    Measured: Baseline up to 1 year

  8. 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: 1 year

Timeline

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

  1. First posted2 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionAug 2008
  4. Study completionAug 2008

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
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00468286
Sponsor's protocol ID
FE200486 CS18
Status last verified
Mar 2011
First submitted
13 Apr 2007
Last updated
23 Mar 2011
Data monitoring committee
Yes

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 29 sites in 5 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 4 inclusion and 0 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 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Romania, Canada, Hungary, Czechia. 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 3 Mar 2011). 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?

Probability of Testosterone at Castration Level (≤0.5 ng/mL) From Day 28 Through Day 364 (time frame: 1 year). 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 NCT00468286.

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 23 Mar 2011.

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