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Trial · Interventional

TerminatedPhase 3Results postedRegistry data

A Degarelix Trial in Patients With Prostate Cancer

NCTNCT01242748 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS35AOther id2010-021434-55
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 3
Enrollment
288 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Not randomized · Open label (no masking)
Countries
13 countries

United States, Belgium, Canada, Czechia, Finland, Germany, Hungary, Mexico, Netherlands, Poland, Romania, Ukraine, United Kingdom

Start
Oct 2010
Primary completion
Dec 2011
Completion
Jan 2012
First posted
17 Nov 2010 (estimated)
Last update posted
3 Jun 2015 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. Ph 3

    A Degarelix Trial in Patients With Prostate Cancer

    NCT01242748

    Oct 2010 to Jan 2012

    Terminated

Registry summary

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

A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.

Interventions

  • DegarelixDrug
  • Goserelin acetateDrug

Arms2

  • Experimental

    Degarelix 240 mg/480 mg

  • Active comparator

    Goserelin acetate

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin

    Time frame · From baseline to 3 years

    Registry description

    PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.

Secondary outcomes(7)

  1. Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin

    Time frame · From baseline to 3 years

    Registry description

    PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.

  2. Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin

    Time frame · From baseline to 3 years

    Registry description

    PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.

  3. Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin

    Time frame · From baseline to 3 years

    Registry description

    Testosterone escape is defined as serum levels \>0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.

  4. Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin

    Time frame · From baseline to 3 years

    Registry description

    Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.

  5. Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin

    Time frame · From baseline to 3 years

    Registry description

    The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.

  6. Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin

    Time frame · Baseline and after 1, 6, 12, 19, and 22 months

    Registry description

    Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.

  7. Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin

    Time frame · Baseline and after 1, 6, 12, 19, and 22 months

    Registry description

    Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.

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 outcomeNumber· From baseline to 3 years

Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin

GroupValue (percentage of no PSA-PFS)
Degarelix 240 mg/480 mg75.5
Goserelin Acetate75.4
Secondary and other outcome results(7)
Secondary outcomeNumber· From baseline to 3 years

Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin

GroupValue (percentage of no PFS failure)
Degarelix 240 mg/480 mg71.5
Goserelin Acetate69.0
Secondary outcomeNumber· From baseline to 3 years

Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin

GroupValue (percentage of no PSA failure)
Degarelix 240 mg/480 mg77.5
Goserelin Acetate79.6
Secondary outcomeNumber· From baseline to 3 years

Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin

GroupValue (percentage of no testosterone escape)
Degarelix 240 mg/480 mg83.7
Goserelin Acetate96.7
Secondary outcomeNumber· From baseline to 3 years

Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin

GroupValue (percentage of no additional therapy)
Degarelix 240 mg/480 mg84.5
Goserelin Acetate83.4
Secondary outcomeNumber· From baseline to 3 years

Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin

GroupValue (percentage of deaths)
Degarelix 240 mg/480 mg4.6
Goserelin Acetate5.3
Secondary outcomeMedian· Baseline and after 1, 6, 12, 19, and 22 months

Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin

GroupValue (ng/mL)
Degarelix 240 mg/480 mg4.52
Goserelin Acetate4.62
Secondary outcomeMedian· Baseline and after 1, 6, 12, 19, and 22 months

Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin

GroupValue (ng/mL)
Degarelix 240 mg/480 mg19
Goserelin Acetate19.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Degarelix 240 mg/480 mgDegarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.–58 / 565430 / 565
Goserelin AcetateGoserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.–33 / 283197 / 283

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 Criteria: * Has given written consent prior to any trial-related activity is performed. (A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient). * Has completed the CS35 trial. Exclusion Criteria: * Has been withdrawn from the CS35 trial. * Has had end of trial visit in CS35 prior to approval of the CS35A protocol.

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