[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635174":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":48,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":11,"maxAge":11,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":78,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Regionshospital Nordjylland","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CBD","EXPERIMENTAL",null,[13],"Drug: Cannabidiol",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Cannabidiol","Name: Cannabidiol, 100 mg\u002Fml Dosage: 2 ml three times a day (=600 mg CBD\u002Fday) Administration form: oil (oral)",[9],[9],{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":11},"Name: Placebo Dosage: 2 ml three times a day (=0 mg CBD\u002Fday) Administration form: oil (oral)",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Peter Derek Christian Leutscher","CONTACT","+4524859576","p.leutscher@rn.dk",[36],{"facility":37,"status":11,"city":38,"state":11,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":11},"Department of Urology, Aalborg University Hospital","Gistrup","9260","Denmark","DK",{"type":43,"coordinates":44},"Point",[45,46],9.99085,56.9943,{"lat":46,"lon":45},{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[51],{"name":52,"class":53},"Aalborg University Hospital","OTHER","100635174","phase-2-cannabidiol-for-pain-relief-of-patients-with-end-stage-mcrpc-100635174",false,"NCT07549256","Cannabidiol for Pain Relief of Patients With End-stage mCRPC","Efficacy and Safety of Cannabidiol for Pain Relief of Patients With End-stage Metastatic Castration Resistant Prostate Cancer - a Randomised Double-blinded Placebo-controlled Phase II Trial","ProCan","Inclusion Criteria:\n\n* Patients diagnosed with mCRPC as documented by increasing PSA 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 since radiation therapy, if part of treatment.\n* Perception of pain\n* Daily use of Morphine (ATC: N02AA01) (10mgx2) in relief of pain.\n\nExclusion Criteria:\n\n* Perception of worst pain \\\u003C4.0 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\u002For three days where pain intensity is at least 4.0).\n* Pattern of short duration of response to all previous treatment regimens (\\\u003C6 months) clinically assessed by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\>3 (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* Functional liver insufficiency with an alanine transaminase (ALT) \\>2X ULN and\u002For bilirubin \\>2X ULN assessed by a blood sample taken at screening.\n* Renal failure with an estimated glomerular filtration rate (eGFR) \\\u003C 30mL\u002Fmin\u002F1,73m2 assessed by a blood sample taken at screening.\n* Known heart failure - New York Heart Association III - IV (scale I-IV)71.\n* Known severe chronic obstructive lung disease (Forced Expiratory Volume in the first second (FEV1) \\\u003C50%)72.\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* Hypersensitivity to the active substance\n* Not capable of giving informed consent.\n* Not capable of understanding, write or read Danish.","MALE",{"count":64,"type":65},58,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","The goal of this clinical trial is to evaluate the effects of cannabidiol in patients with end-stage metastatic castration-resistant prostate cancer (mCRPC).\n\nThe primary objective is to determine whether cannabidiol (CBD) treatment can reduce the need for opioids in patients with end-stage mCRPC.\n\nAdditionally, the study will assess a range of clinical endpoints in patients with end-stage mCRPC, including:\n\n1. The efficacy of CBD treatment in alleviating pain\n2. The efficacy of CBD treatment in reducing the need for non-opioid medications and concomitant therapies\n3. The impact of CBD treatment on physical activity and quality of life\n4. The anti-inflammatory and potential anti-tumor properties of CBD\n5. The safety of CBD treatment\n\nPatients from Department of Urology, Aalborg University Hospital will be included. Participants will be treated with either CBD (200 mg) or placebo (0 mg) three times daily for nine weeks. At baseline, halfway and end of trial, participants will use an activity tracker and complete questionnaires regarding pain and quality of life and provide blood samples to measure inflammation and tumor activity. Also, they will complete a daily dairy regarding the study drug and intake of pain medication. Adverse events will be assessed by Common Terminology Criteria for Adverse Events.",[71],"Metastatic Castration Resistant Prostate Cancer (mCRPC)",[22,9,73,74,75,76,77],"Prostate cancer","Adjuvant palliative therapy","Cannabis","Metastatic castration resistant prostate cancer","mCRPC","NOT_YET_RECRUITING","2026-04-17",{"date":81,"type":82},"2026-04-24","ACTUAL",{"date":84,"type":65},"2026-06-01",{"date":86,"type":65},"2029-01",{"name":5,"class":6},1]