Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer (IM1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01491971
Recruitment Status : Completed
First Posted : December 14, 2011
Last Update Posted : December 12, 2013
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Degarelix Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Multi-centre, Parallel Group Dose-Escalation Trial Assessing the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer
Study Start Date : January 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Degarelix
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Degarelix - Cohort 1
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Drug: Degarelix
Experimental: Degarelix - Cohort 2
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Drug: Degarelix
Experimental: Degarelix - Cohort 3
(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Drug: Degarelix

Primary Outcome Measures :
  1. Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax) [ Time Frame: Day 0-28 and at Day 112-140 ]
  2. Trough plasma levels (blood sample analysis) [ Time Frame: Day 28, 56, 84, 112, 140, 168 and 196 ]
    Actual levels prior to dosing

Secondary Outcome Measures :
  1. Proportion of patients with testosterone ≤0.5 ng/mL [ Time Frame: From baseline to Day 196 ]
  2. Serum levels of testosterone and PSA [ Time Frame: From baseline to Day 196 ]
  3. Percentage change in PSA levels [ Time Frame: From baseline to Day 196 ]
  4. Changes in patient-reported injection site pain (VAS scores over time) [ Time Frame: At 5 minutes and at 60 minutes after each injection ]
    Will compare starting dose to maintenance doses

  5. Proportion of patients without clinically significant pain (VAS score of ≤10 mm) [ Time Frame: 60 minutes after each dosing injection ]
  6. Incidence and severity of investigator-evaluated injection site reactions [ Time Frame: From baseline to Day 196 ]
  7. Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit [ Time Frame: From Day 28 onwards (up to Day 196) ]
  8. Predictive one-year suppression rate and 95% CI: The cumulative probability of suppressing testosterone to castrate levels (≤0.5 ng/mL) [ Time Frame: From Day 28 to Day 364 ]
  9. Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs [ Time Frame: From baseline to Day 196 ]
  10. Clinically significant changes in laboratory values [ Time Frame: From baseline to Day 196 ]
  11. Clinically significant changes in ECGs, vital signs, physical examinations, and body weight [ Time Frame: From baseline to Day 196 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Has a histologically confirmed adenocarcinoma of the prostate, for which endocrine therapy is indicated
  • Has a current tumour, nodule and metastasis (TNM) staging within 12 weeks prior to treatment start and, if clinically indicated a bone scan
  • Has a PSA level meeting one of these criteria:

    1. For treatment-naïve patients: Screening PSA level should be ≥2 ng/mL.
    2. For patients with recurrence after radical prostatectomy: Patients should have a serum PSA increase of ≥0.2 ng/mL from the previous test on two consecutive measurements
    3. For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir
  • Has a screening serum testosterone level above the lower limit of normal range in an elderly male population, globally defined as >150 ng/dL
  • Has an Eastern Cooperative Oncology Group score of ≤2
  • Has a life expectancy of at least one year

Exclusion Criteria:

  • Has had previous or is currently under hormonal management of prostate cancer
  • Is considered to be a candidate for curative therapy i.e. radical prostatectomy or radiotherapy during the trial period
  • Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
  • Has a marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms)
  • Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome)
  • Has a previous history or presence of another malignancy, other than prostate
  • Currently receiving chronic treatment with intramuscular medication injected into the ventrogluteal or dorsogluteal muscle
  • Has received an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01491971

United States, Alabama
Urology Centers of Alabama
Homewood, Alabama, United States
United States, California
South Orange County Urology Research
Laguna Hills, California, United States
San Bernadino Urological Association
San Bernadino, California, United States
United States, Florida
South Florida Medical Research
Aventura, Florida, United States
United States, New York
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
United States, North Carolina
Carolina Clinical Trials
Concord, North Carolina, United States
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
United States, Texas
Urology Clinic of North Texas
Dallas, Texas, United States
Urology San Antonio Research, Pa
San Antonio, Texas, United States
Canada, British Columbia
Pacific Urologic Research
Victoria, British Columbia, Canada
Canada, Ontario
Euroscope Inc
Barrie, Ontario, Canada
Bramalea Medical Centre
Brampton, Ontario, Canada
Urology Associates/Urologic Medical Research
Kitchener, Ontario, Canada
Office of Dr. Bernard Goldfarb
North Bay, Ontario, Canada
Canada, Quebec
Urology South Shore Research
Greenfield Park, Quebec, Canada
Sponsors and Collaborators
Ferring Pharmaceuticals
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals Identifier: NCT01491971     History of Changes
Other Study ID Numbers: 000008
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases