Randomized, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients with Prostate Cancer and Cardiovascular Disease Receiving Degarelix or Leuprolide

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10071119Term: Hormone-dependent prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Advanced Prostate Cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002495-20-DE
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-16
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 900

Inclusion Criteria

1.Signed informed consent obtained before any trial-related activity is performed.
2.Histologically confirmed adenocarcinoma of the prostate.
3.Clinical tumor staging (Tumor, Nodule and Metastasis [TNM]) available prior to treatment start; radiographic imaging (bone scan and/or CT scan and/or MRI) performed within 3 months prior to randomization. If no radiographic image is available at the time of screening, a bone scan should be performed.
4.Investigator judgment to initiate continued androgen deprivation therapy (ADT) with an intended treatment duration of 12 months or longer including any of the following disease categories:
A.Patients with metastatic prostate cancer at the time of diagnosis.
B.Patients with prostate cancer who develop metastases after local therapy.
C.Patients with prostate cancer with very high-risk, high-risk or intermediate-risk disease with features of unfavourable prognosis who are going to be treated with definitive radiation therapy in combination with at least 12 months of neoadjuvant/adjuvant ADT.
D.Patients with biochemical recurrence after local therapy who have a PSA doubling time <12 months.
E.Patients previously treated with definitive local therapy (without ADT combination) who due to risk features such as positive margins, seminal vesicle invasion, extracapsular extension, or detectable PSA, will be treated with salvage radiation therapy in combination with neoadjuvant/adjuvant ADT that is planned for 12 months or longer.
F.Patients with locally advanced prostate cancer who are not candidates (who are unsuited) for definitive therapy with surgery or radiation and will be treated with primary ADT.
5.Patients must be treatment-naïve with regard to ADT at time of randomization (with the exception of prior history of neoadjuvant/adjuvant ADT to definitive therapy for which the last administration, e.g., injection of a depot ADT formulation was at least 12 months prior to randomization).
6.Patients must have a screening serum testosterone level above the lower limit of normal range, defined as >150 ng/dL (5.2 nmol/L), apart from those who had prior neoadjuvant/adjuvant ADT (>12 months prior to randomization) where non-castrate range (>50 ng/dL or =1.73 nmol/L) should be applied.
7.Patients must have an Eastern Cooperative Oncology Group (ECOG) score of =2.
8.Pre-existing CVD (confirmed diagnosis prior to randomization) with at least one of the following criteria documented with applicable medical source documents:
A.Prior myocardial infarction =30 days before randomization.
B.Prior revascularization procedure =30 days before randomization, specified as any of the following:
Coronary artery stent placement or coronary artery balloon angioplasty
Coronary artery bypass graft surgery
Stent placement or balloon angioplasty to a carotid, iliac, femoral, or popliteal artery
Carotid endarterectomy surgery
Vascular bypass surgery of the iliac, femoral, or popliteal arteries
C.Results from an angiogram or CT angiogram of the coronary, carotid, iliac, femoral, or popliteal arteries that documented at least one vascular stenosis =50% at any time point before randomization.
D.Carotid ultrasound results that documented a vascular stenosis =50% at any time point before randomization.
E.Ankle-brachial pressure index (ABPI) <0.9 at any time point before randomization.

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 sub

Exclusion Criteria

1.Previous or current hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, ketoconazole, abiraterone and enzalutamide); except neoadjuvant/adjuvant ADT (in this case treatment has to be terminated at least 12 months prior to randomization).
2.Hypersensitivity towards any component of the IMPs or excipients.
3.Uncontrolled type 1 or type 2 diabetes mellitus (defined as hemoglobin A1c [HbA1c] >10%) at time of randomization.
4.Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) at time of randomization.
5.A history of congenital Long QT Syndrome or risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, concomitant medication known to cause QT prolongation).
6.Myocardial infarction within 30 days prior to randomization.
7.Stroke (hemorrhagic or ischemic) within 30 days prior to randomization.
8.Coronary, carotid, or peripheral artery revascularization within 30 days prior to randomization.
9.Planned or scheduled cardiac surgery or PCI procedure that is known at the time of randomization.
10.Other clinically significant disorder (other than prostate cancer and CVD) including, but not limited to, renal, hematological, gastrointestinal, endocrine, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient’s health or the outcome of the trial as judged by the Investigator.
11.Mental incapacity or language barrier precluding adequate understanding or co-operation.
12.Treatment with an investigational drug within the last month prior to randomization or longer if considered to possibly influence the outcome of the current trial or planned or concurrent participation in a clinical trial for any investigational drug or device.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified