Cannabidiol for Pain Relief of Patients With End-stage mCRPC

Ki vehet részt

• Patients diagnosed with mCRPC as documented by increasing PSA despite optimally attempted treatment, and no other therapeutic options
• Treatment-resistance or ineligible to standardized cancer therapy, incl. medical and surgical castration, chemotherapy, and super hormone treatment
• Minimum 3 months since radiation therapy, if part of treatment
• Opioid-requiring pain

Ki nem vehet részt

• Perception of worst pain <4.0 on the NRS within the last week prior to baseline visit70. (Inclusion if: three days with highest pain intensity have an average of ≥4.0 and/or three days where pain intensity is at least 4.0)
• Pattern of short duration of response to all previous treatment regimens (<6 months) clinically assessed by the investigator
• Change in regular use of conventional pain medication within two weeks prior to baseline visit
• A history of substance use disorder
• Known heart failure - New York Heart Association III - IV (scale I-IV)71
• Known severe chronic obstructive lung disease (Forced Expiratory Volume in the first second (FEV1) <50%)72
• Any chronic or acute systemic medical condition that, in the opinion of the investigator, may pose a risk to the safety of the patient or may interfere with compliance or the assessment of efficacy in this trial
• Hypersensitivity to the active substance
• Functional liver insufficiency with an alanine transaminase (ALT) >2X ULN and/or bilirubin >2X ULN assessed by a blood sample taken at screening
• Renal failure with an estimated glomerular filtration rate (eGFR) < 30mL/min/1,73m2 assessed by a blood sample taken at screening
• Eastern Cooperative Oncology Group (ECOG) performance status >3 (scale 0-5)
• Use of THC-containing cannabis products measured by a urine sample at screening
• Not capable of giving informed consent
• Not capable of understanding, write or read Danish