CANNABIDIOL for Prostate cancer | Castration-resistant prostate cancer

Inclusion criteria

• {"criterion_text":"- Patients diagnosed with mCRPC as documented by increasing prostate specific antigen despite optimally attempted treatment, and no other therapeutic options.\n- Treatment-resistance or ineligible to standardized cancer therapy, incl. medical and surgical castration, chemotherapy, and super hormone treatment\n- Minimum 3 months radiation therapy, if part of treatment\n- Perception of pain\n- Daily use of morphine ATC N02AA01 (10 mg x2) in relief of pain"}

Exclusion criteria

• {"criterion_text":"- 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)\n- Known severe chronic obstructive lung disease (Forced Expiratory Volume in the first second (FEV1) <50%)\n- Use of THC-containing cannabis products measured by a urine sample at screening\n- 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\n- Not capable of giving informed consent\n- Not capable of understanding, write or read Danish\n- Pattern of short duration of response to all previous treatment regimens (<6 months) clinically assessed by the investigator\n- Eastern Cooperative Oncology Group (ECOG) performance status ≥3 or higher (scale 0-5)\n- Change in regular use of conventional pain medication within two weeks prior to baseline visit\n- A history of substance use disorder\n- Hypersensitivity to the active substance\n- Functional liver insufficiency with an alanine transaminase (ALT) >2X ULN and/or bilirubin >2X ULN assessed by a blood sample taken at screening\n- Renal failure with an estimated glomerular filtration rate (eGFR) < 30mL/min/1,73m2 assessed by a blood sample taken at screening\n- Known heart failure - New York Heart Association III – IV (scale I-IV)"}

Primary endpoints

• {"endpoint_text":"- Difference in average total daily dose of opioids (morphine milligram equivalents) during the trial participation with particular focus on the last week prior to end of trial (EOT) comparatively between study participants receiving CBD and placebo, respectively","definition_or_measurement_approach":"Measured as difference in average total daily opioid dose expressed in morphine milligram equivalents during trial participation, with particular focus on the last week prior to end of trial (EOT); comparison between CBD and placebo arms."}

Secondary endpoints

• {"endpoint_text":"- Difference in average worst pain intensity on numeric rating scale (NRS) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.","definition_or_measurement_approach":"Measured as difference in average worst pain intensity on NRS during trial participation, with focus on last week prior to EOT; comparison between CBD and placebo."}
• {"endpoint_text":"- Difference in interference of pain on daily functioning by Brief Pain Inventory during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.Short Form (BPI-SF) Interference Items","definition_or_measurement_approach":"Measured by Brief Pain Inventory Short Form (BPI-SF) interference items; comparison between CBD and placebo with focus on last week prior to EOT."}
• {"endpoint_text":"- Difference in average total daily dose of non-opioid analgesics (e.g., NSAID, paracetamol, secondary analgesics) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.","definition_or_measurement_approach":"Measured as difference in average total daily dose of non-opioid analgesics during trial participation, focus on last week prior to EOT; comparison between arms."}
• {"endpoint_text":"- Difference in use of concomitant therapy (e.g., radiation, corticosteroids) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.","definition_or_measurement_approach":"Assessed as difference in use of concomitant therapies during trial participation, focusing on last week prior to EOT; comparison between arms."}
• {"endpoint_text":"- Difference in quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core 30 (EORTC-QLQ-C30) and European Organization for Research and Treatment of Cancer Quality of Life Prostate Cancer (EORTC-QLQ-PR25) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.","definition_or_measurement_approach":"Measured by EORTC-QLQ-C30 and EORTC-QLQ-PR25 questionnaires; comparison between arms focusing on last week prior to EOT."}
• {"endpoint_text":"- Difference in physical activity by average daily steps during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.","definition_or_measurement_approach":"Measured as difference in average daily steps during participation, focus on last week prior to EOT; comparison between arms."}
• {"endpoint_text":"- Difference in tumour activity by average serum prostate-specific antigen (PSA) and alkaline phosphatase (ALP) levels during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.","definition_or_measurement_approach":"Measured by average serum PSA and ALP levels during participation, focusing on last week prior to EOT; comparison between arms."}
• {"endpoint_text":"- Difference in inflammation by average serum c-reactive protein (CRP), plasma cytokines and plasma soluble urokinase plasminogen activator receptor (suPAR) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.","definition_or_measurement_approach":"Measured by average serum CRP, plasma cytokines and suPAR levels during participation, focusing on last week prior to EOT; comparison between arms."}
• {"endpoint_text":"- Difference in safety profile outcomes by laboratory testing of routine blood samples and Common Terminology Criteria for Adverse Events (CTCAE 5.0) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.","definition_or_measurement_approach":"Safety assessed by routine laboratory tests and CTCAE v5.0 adverse event grading; comparison between arms, focus on last week prior to EOT."}

Denmark

Earliest CTIS Part Ii Submission Date

08-04-2025

Latest Decision Or Authorization Date

03-03-2026

Processing Time Days

329

Number Of Sites

1

Number Of Participants

58

Primary sponsor

Full Name

Regionshospital Nordjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Glostrup Apotek","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
• {"country":"Denmark","full_name":"Aalborg University Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}