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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00468286 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS18
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
133 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Randomized · Open label (no masking)
Countries
5 countries

United States, Canada, Czechia, Hungary, Romania

Start
May 2007
Primary completion
Aug 2008
Completion
Aug 2008
First posted
2 May 2007 (estimated)
Last update posted
23 Mar 2011 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 2

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

    NCT00468286

    May 2007 to Aug 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DegarelixDrug
  • DegarelixDrug

Arms2

  • Experimental

    A

    Treatment 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.

  • Experimental

    B

    Treatment 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 1 year

    Registry description

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

Secondary outcomes(8)

  1. Serum Levels of Testosterone Over Time

    Time frame · 1 year

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

    Time frame · 1 year

    Registry description

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

  3. Probability of no PSA Failure

    Time frame · 1 year

    Registry description

    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).

  4. Serum Levels of PSA Over Time

    Time frame · 1 year

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

    Time frame · 1 year

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

    Time frame · 1 year

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

    Time frame · Baseline up to 1 year

    Registry description

    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.

  8. Liver Function Tests

    Time frame · 1 year

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 1 year

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

GroupValue (percentage of participants)
Degarelix 240/360 mg89.0
Degarelix 240/480 mg93.3
Secondary and other outcome results(7)
Secondary outcomeMedian· 1 year

Serum Levels of Testosterone Over Time

GroupValue (ng/mL)
Degarelix 240/360 mg0.1
Degarelix 240/480 mg0.1
Secondary outcomeMean· 1 year

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

GroupValue (percentage of participants)
Degarelix 240/360 mg89.0
Degarelix 240/480 mg93.3
Secondary outcomeMean· 1 year

Probability of no PSA Failure

GroupValue (percentage of participants)
Degarelix 240/360 mg93.5
Degarelix 240/480 mg94.6
Secondary outcomeMedian· 1 year

Serum Levels of PSA Over Time

GroupValue (ng/mL)
Degarelix 240/360 mg3.5
Degarelix 240/480 mg3.1
Secondary outcomeMedian· 1 year

Serum Levels of Follicle Stimulating Hormone (FSH) Over Time

GroupValue (IU/L)
Degarelix 240/360 mg0.3
Degarelix 240/480 mg0.4
Secondary outcomeMedian· 1 year

Serum Levels of Luteinizing Hormone (LH) Over Time

GroupValue (IU/L)
Degarelix 240/360 mg0.1
Degarelix 240/480 mg0.1
Secondary outcomeNumber· Baseline up to 1 year

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

GroupValue (participants)
Degarelix 240/360 mg0
Degarelix 240/480 mg0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Degarelix 240/360 mgTreatment 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.–7 / 6749 / 67
Degarelix 240/480 mgTreatment 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.–11 / 6653 / 66

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion / Exclusion Criteria: * 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.

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