Phase
Condition
Prostate Cancer
Prostate Cancer, Early, Recurrent
Prostate Disorders
Treatment
N/AClinical Study ID
Ages > 18 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged ≥18 years with a diagnosis of adenocarcinoma of the prostate (Gleason graded, allstages) where endocrine treatment is indicated.
Caucasian origin.
Able to provide written Informed Consent and willing and able to comply with trialprocedures.
Body mass index (BMI) between 18.5-30 kg/m2.
Has a life expectancy of at least one year.
Exclusion
Exclusion Criteria:
Current hormonal management of prostate cancer.
Previous endocrine therapy for prostate cancer within 3 months prior to the screeningvisit.
Any medical injection therapy that might interfere with degarelix injections.
Patients with advanced muscle atrophy or cachexia which in the Investigator's opinionwould preclude or pose risks of complications following ventrogluteal i.m. injectionof degarelix.
Any medical condition that could be aggravated or may cause extreme discomfort duringthe trial period or could cause a moderate risk to a patient (significant heart, renalor liver disease).
Chronic pain syndrome or any continuous pain reported by the patient that, accordingto the judgement of the Investigator, could limit the evaluation of injection relatedpain.
Study Design
Connect with a study center
Tampereen yliopistollinen sairaala (there may be other sites in this country)
Tampere,
FinlandSite Not Available
Groupe Hospitalier Pellegrin Tripode (there may be other sites in this country)
Bordeaux,
FranceSite Not Available
Universitaetsklinikum Freiburg (there may be other sites in this country)
Freiburg,
GermanySite Not Available
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