Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ferring Pharmaceuticals
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
