A study investigating if markers for inflammation in the blood in patients with prostate cancer is affected by type of hormonal treatment received.

Phase 1

Conditions: Patients with advanced prostate cancer and pre-existing cardiovascular disease
MedDRA version: 19.1Level: LLTClassification code 10036916Term: Prostate cancer stage DSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-004120-39-SE

Lead Sponsor: Region Skåne

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

18 years of age or above
Patients with advanced prostate cancer and scheduled for androgen deprivation treatment for at least 8 weeks
Patients with a history of cardiovascular disease according to specified criteria
Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Current or prior use in the past 6 months of androgen deprivation therapy
Prior use of dutasteride/finasteride or antiandrogen in the past 6 months
Ongoing diagnosed chronic or immune disease
Known or suspected allergy to medications used in the study
QT-interval at ECG>450 ms
Subject has total bilirubin >= 1.5 x ULN (except subjects with Gilberts disease), or alanine aminotransferase (ALT) or aspartate aminotransferase >= 2.5 x ULN at screening
Creatine > 2 mg/dL (177 umol) at screening

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess and compare inflammatory and immune biomarkers in patients with a with advanced prostate cancer and a history of cardiovascular disease and treated with either a GNRH agonist (Leuprorelin ) or a GnRH antagonist (degarelix).;Secondary Objective: Not applicable;Primary end point(s): To show a difference in immune and inflammatory biomarker pattern between patients treated with degarelix and leuprorelin;Timepoint(s) of evaluation of this end point: At 2, 4 and 8 weeks after start of ADT treatment.

Secondary Outcome Measures