Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Adenocarcinoma of the Prostate
  • Metastatic Castration Resistant Prostate Cancer
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

Prostate cancer is one of the leading cause of cancer death among males worldwide. The objective of this phase II, randomized, controlled, open label study is to evaluate the effectiveness and safety of MAO-B (Monoamine oxidases-B) inhibitor selegiline plus docetaxel therapy. Patients diagnosed with...

Prostate cancer is one of the leading cause of cancer death among males worldwide. The objective of this phase II, randomized, controlled, open label study is to evaluate the effectiveness and safety of MAO-B (Monoamine oxidases-B) inhibitor selegiline plus docetaxel therapy. Patients diagnosed with metastatic, castrate-resistant prostate adenocarcinoma are randomly divided into two groups. One group (control arm) receives docetaxel (75 mg/m2 IV every 3 weeks for maximum of 12 cycles). Another group (experimental arm) receives docetaxel (75 mg/m2 IV every 3 weeks for maximum of 12 cycles) plus selegiline (daily 10 mg tablet). Patients are followed up for 36 months or until the end of the trial, death or withdraw from this study due to other reasons. The primary endpoint of this study is the proportion of patients without progression at month 9. The secondary endpoint is proportion of patients without progression at month 12/18, progression-free survival, overall survival, duration of PSA response, radiological response rate, PSA response rate, health-related quality of life and safety.

Tracking Information

NCT #
NCT04586543
Collaborators
E-Group ICT Software Informatikai Zrt.
Investigators
Not Provided