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

Ferring

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Degarelix

Study type: Interventional

Funder types: Industry

Identifiers

NCT01491971

000008

Details and patient eligibility

About

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

Enrollment: 76 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 3 patient groups

Degarelix - Cohort 1

Experimental group

Description:

(gonadotrophin-releasing hormone (GnRH) receptor blocker)

Treatment:

Drug: Degarelix

Degarelix - Cohort 2

Experimental group

Description:

(gonadotrophin-releasing hormone (GnRH) receptor blocker)

Treatment:

Drug: Degarelix

Degarelix - Cohort 3

Experimental group

Description:

(gonadotrophin-releasing hormone (GnRH) receptor blocker)

Treatment:

Drug: Degarelix