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
You may not be if
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.
Eastern Cooperative Oncology Group (ECOG) performance status \>3 (scale 0-5).
Change in regular use of conventional pain medication within two weeks prior to baseline visit.
A history of substance use disorder.
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.
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.
Use of THC-containing cannabis products measured by a urine sample at screening.
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
Not capable of giving informed consent.
Not capable of understanding, write or read Danish.
Clareo Health | Cannabidiol for Pain Relief of Patients With End-stage mCRPC
