NCT04586543

Clinical Trial of Selegiline Plus Docetaxel for the Treatment of Metastatic, Castrate-resistant Prostate Adenocarcinoma

A Clinical Trial of Selegiline Plus Docetaxel for the Treatment of Metastatic, Castrate-resistant Prostate Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: László Mangel · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical study is to evaluate the effectiveness and safety of selegiline plus docetaxel therapy compared to the standard of care - docetaxel therapy - among patients diagnosed with metastatic, castrate-resistant prostate adenocarcinoma.

Detailed 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 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.

Conditions

• Metastatic Castration-resistant Prostate Cancer
• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
DRUG	Selegiline	10 mg selegiline tablet per day
DRUG	Docetaxel	75mg/m2 docetaxel infusion every 3 weeks for maximum of 12 cycles

Timeline

• Start date: 2020-05-18
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2020-10-14
• Last updated: 2020-10-14

Locations

1 site across 1 country: Hungary