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

An experimental pilot study on immune and inflammatory biomarkers in patients with advanced prostatecancer treated with degarelix vs. GnRH agonist and with cardiovascular disease

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004120-39-SE

Enrollment

Unknown

Registered

2017-01-13

Start date

2017-03-13

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with advanced prostate cancer and pre-existing cardiovascular disease MedDRA version: 19.1 Level: LLT Classification code 10036916 Term: Prostate cancer stage D System Organ Class: 100000004864

Interventions

Trade Name: Firmagon 120 mg pulver och vätska till injektionsvätska lösning Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Degarelix CAS Number: 934016-19-0 O

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Sweden

Contacts

Public ContactAnders Bjartell

Region Skåne

anders.bjartell@med.lu.se0046040336398

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026