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

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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Degarelix

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with testosterone ≤0.5 ng/mL		From baseline to Day 196
Serum levels of testosterone and PSA		From baseline to Day 196
Percentage change in PSA levels		From baseline to Day 196
Changes in patient-reported injection site pain (VAS scores over time)	Will compare starting dose to maintenance doses	At 5 minutes and at 60 minutes after each injection
Proportion of patients without clinically significant pain (VAS score of ≤10 mm)		60 minutes after each dosing injection
Incidence and severity of investigator-evaluated injection site reactions		From baseline to Day 196
Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit		From Day 28 onwards (up to Day 196)
Predictive one-year suppression rate and 95% CI: The cumulative probability of suppressing testosterone to castrate levels (≤0.5 ng/mL)		From Day 28 to Day 364
Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs		From baseline to Day 196
Clinically significant changes in laboratory values		From baseline to Day 196
Clinically significant changes in ECGs, vital signs, physical examinations, and body weight		From baseline to Day 196

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: December 12, 2011
• First Posted (Estimate): December 14, 2011

Study Record Updates

• Last Update Posted (Estimate): December 12, 2013
• Last Update Submitted That Met QC Criteria: November 18, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 000008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No