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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT01491971
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-14
• Study Start: 2012-01
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-11
• Disposition First Submitted: 2013-11-18
• Disposition First Submitted QC: 2013-11-18
• Last Update Submitted: 2013-11-18
• Disposition First Posted: 2013-12-12
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Degarelix - Cohort 1	Degarelix	(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Degarelix - Cohort 2	Degarelix	(gonadotrophin-releasing hormone (GnRH) receptor blocker)
Degarelix - Cohort 3	Degarelix	(gonadotrophin-releasing hormone (GnRH) receptor blocker)

Primary Outcome Measures

Name	Time	Method
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)	Day 28, 56, 84, 112, 140, 168 and 196	Actual levels prior to dosing

Secondary Outcome Measures

Name	Time	Method
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)	At 5 minutes and at 60 minutes after each injection	Will compare starting dose to maintenance doses
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

Trial Locations

Locations (15)

South Orange County Urology Research; 🇺🇸 Laguna Hills, California, United States

Bramalea Medical Centre; 🇨🇦 Brampton, Ontario, Canada

South Florida Medical Research; 🇺🇸 Aventura, Florida, United States

Urology Clinic of North Texas; 🇺🇸 Dallas, Texas, United States

Urology South Shore Research; 🇨🇦 Greenfield Park, Quebec, Canada

Euroscope Inc; 🇨🇦 Barrie, Ontario, Canada

Urology San Antonio Research, Pa; 🇺🇸 San Antonio, Texas, United States

Urology Centers of Alabama; 🇺🇸 Homewood, Alabama, United States

Carolina Clinical Trials; 🇺🇸 Concord, North Carolina, United States

Office of Dr. Bernard Goldfarb; 🇨🇦 North Bay, Ontario, Canada

San Bernadino Urological Association; 🇺🇸 San Bernadino, California, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Premier Medical Group of the Hudson Valley; 🇺🇸 Poughkeepsie, New York, United States

Pacific Urologic Research; 🇨🇦 Victoria, British Columbia, Canada

Urology Associates/Urologic Medical Research; 🇨🇦 Kitchener, Ontario, Canada