Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer

Speciality European Pharma Limited177 enrolled

Overview

To compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.

Inclusion Criteria * Males over 18 with documented advanced or metastatic prostate cancer Outcome measures * Comparative castration rates one week after starting therapy * Degree of testosterone surge in the first month of treatment. * Maintenance of medical castration during one year of therapy. * Comparison of the treatments on QTc prolongation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

177

Conditions

Prostate Cancer

Interventions

AbarelixDRUG

100 mg by Intramuscular injection on days; 1, 15 and 29 and monthly thereafter

Goserelin plus BicalutamideDRUG

Goserelin - 3.6 mg by monthly subcutaneous injection Biaclutamide 50 mg orally daily for first three months

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically proven prostate cancer and not previously treated with hormones * Evidance of advanced disease or metastases * Life expentancy of at least 3 months * Normal serum testosterone levels * Written informed consent Exclusion Criteria: * Previous endocrine or cytoxic theapy for prostate cancer * Known tumour complication of prostate cancer which owuld require immediate treatment * Another malignancy other than basal cell cancer * History of significant drug hypersensitivity to either LHRH agonists or GnRH antagonists. * Congenital or acquired coagulation disorders contraindicating intramuscular injections * Pagets disease of the bone * QTcB \> 450 msec at Day - 14

Outcomes

Primary Outcomes

Early castration rates

Time frame: One week

Secondary Outcomes

Maintenance of medical castration

Time frame: 48 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.