Clinical trial NCT01491971: Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-12-14
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax)
timeFrame: Day 0-28 and at Day 112-140
measure: Trough plasma levels (blood sample analysis)
timeFrame: Day 28, 56, 84, 112, 140, 168 and 196
Secondary outcomes:
measure: Proportion of patients with testosterone ≤0.5 ng/mL
timeFrame: From baseline to Day 196
measure: Serum levels of testosterone and PSA
timeFrame: From baseline to Day 196
measure: Percentage change in PSA levels
timeFrame: From baseline to Day 196
measure: Changes in patient-reported injection site pain (VAS scores over time)
timeFrame: At 5 minutes and at 60 minutes after each injection
measure: Proportion of patients without clinically significant pain (VAS score of ≤10 mm)
timeFrame: 60 minutes after each dosing injection
measure: Incidence and severity of investigator-evaluated injection site reactions
timeFrame: From baseline to Day 196
measure: Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit
timeFrame: From Day 28 onwards (up to Day 196)
measure: Predictive one-year suppression rate and 95% CI: The cumulative probability of suppressing testosterone to castrate levels (≤0.5 ng/mL)
timeFrame: From Day 28 to Day 364
measure: Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs
timeFrame: From baseline to Day 196
measure: Clinically significant changes in laboratory values
timeFrame: From baseline to Day 196
measure: Clinically significant changes in ECGs, vital signs, physical examinations, and body weight
timeFrame: From baseline to Day 196
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Laguna Hills
country: United States
facility: South Orange County Urology Research
state: California
city: San Bernadino
country: United States
facility: San Bernadino Urological Association
state: California
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Concord
country: United States
facility: Carolina Clinical Trials
state: North Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Dallas
country: United States
facility: Urology Clinic of North Texas
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research, Pa
state: Texas
city: Victoria
country: Canada
facility: Pacific Urologic Research
state: British Columbia
city: Barrie
country: Canada
facility: Euroscope Inc
state: Ontario
city: Brampton
country: Canada
facility: Bramalea Medical Centre
state: Ontario
city: Kitchener
country: Canada
facility: Urology Associates/Urologic Medical Research
state: Ontario
city: North Bay
country: Canada
facility: Office of Dr. Bernard Goldfarb
state: Ontario
city: Greenfield Park
country: Canada
facility: Urology South Shore Research
state: Quebec
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: