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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
10 mg selegiline tablet per day
75mg/m2 docetaxel infusion every 3 weeks for maximum of 12 cycles
University of Pécs, Clinical Centre, Department of Oncotherapy
Pécs, Baranya, Hungary
RECRUITINGProportion of patients without progression at month 9
Proportion of patients without progression at month 9. Progression can be identified by clinical symptoms, PSA levels, or radiographic imaging as follows, based on PCWG2 criteria: 1. Progression based on clinical symptoms: 1. Decline in ECOG performance status (≥ grade 3), 2. Initiation of newly adjusted chronic opioid analgesic therapy, which may be, i.Use of oral opioid for at least 3 weeks ii.Use of parenteral opioid for at least 7 days c.Necessity to initiate alternative cytotoxic chemotherapy or other active systemic oncology treatment d.Immediate need for radiation or surgical intervention to treat tumor progression OR 2. PSA progression: Date at which the PSA level is increased by at least 25% relative to nadir and at least 2 ng / mL absolute increase compared to the nadir. Values are confirmed 4-6 weeks later by a test. OR 3. Radiological 1. Progression by RECIST 1.1. 2. Bone scan progression: A total of ≥ 2 new lesion compared to baseline
Time frame: 12 months
Proportion of patients without progression at month 12
Time frame: 15 months
Proportion of patients without progression at month 18
Time frame: 21 months
Progression-free survival (biochemical, clinical, radiological
Time frame: 5 years
Overall survival
Time frame: 5 years
Duration of PSA response
Time frame: 5 years
Radiological Response Rate
Time frame: 5 years
PSA Response Rate
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 5 years
Health-Related Quality of Life
Time frame: 5 years