A Phase 2 interventional study of Cannabidiol and Placebo in Metastatic Castration Resistant Prostate Cancer (mCRPC), sponsored by Regionshospital Nordjylland. Recruiting at 1 site in Denmark. Open to male participants. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Regionshospital Nordjylland · Phase 2, Interventional, and Supportive care
The goal of this clinical trial is to evaluate the effects of cannabidiol in patients with end-stage metastatic castration-resistant prostate cancer (mCRPC).
The primary objective is to determine whether cannabidiol (CBD) treatment can reduce the need for opioids in patients with end-stage mCRPC.
Additionally, the study will assess a range of clinical endpoints in patients with end-stage mCRPC, including:
Patients 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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 58 is close to the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Regionshospital Nordjylland is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Cannabidiol
Drug: Placebo
Name: Cannabidiol, 100 mg/ml Dosage: 2 ml three times a day (=600 mg CBD/day) Administration form: oil (oral)
Also known as: CBD
Name: Placebo Dosage: 2 ml three times a day (=0 mg CBD/day) Administration form: oil (oral)
Total daily dose of opioids (morphine milligram equivalents)
Difference in average total daily dose of opioids (morphine milligram equivalents) between study participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
Worst pain intensity on numeric rating scale (NRS)
Difference in average worst pain intensity on numeric rating scale (NRS) between participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
Interference of pain on daily functioning
Difference in interference of pain on daily functioning by Brief Pain Inventory Short Form (BPI-SF) Interference Items between participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
Total daily dose of non-opioid analgesics
Differnece in average total daily dose of non-opioid analgesics (e.g., NSAID, paracetamol, secondary analgesics) between participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
Use of concomitant therapy
Difference in use of concomitant therapy (e.g., radiation, corticosteroids) between participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
Quality of life by EORTC-QLQ-C30
Difference in quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core 30 (EORTC-QLQ-C30) including global health status/quality of life (two items), functional scale (five items) and symptom scale (nine items). The scales range in score from 0 to 100. A high score for the global health status/quality of life represents a high quality of life. A high score for a functional scale represents a high level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Time frame: Baseline and 9 weeks
Quality of life by EORTC-QLQ-PR25
Difference in quality of life by European Organization for Research and Treatment of Cancer Quality of Life Prostate Cancer (EORTC-QLQ-PR25) including functional scale (two items) and symptom scale (four items). The scales range in score from 0 to 100. A high score for a functional scale represents a high level of functioning. A high score for a symptom scale represents a high level of symptomatology.
Time frame: Baseline and 9 weeks
Physical activity
Difference in physical activity by average daily steps between participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
Tumour activity
Difference in tumour activity by average serum prostate-specific antigen (PSA) and alkaline phosphatase (ALP) levels between participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
Inflammation
Difference in inflammation by average serum c-reactive protein (CRP), plasma cytokines and plasma soluble urokinase plasminogen activator receptor (suPAR) between participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
Safety profile outcomes
Difference in safety profile outcomes by laboratory testing of routine blood samples and Common Terminology Criteria for Adverse Events (CTCAE 5.0) between participants receiving CBD and placebo.
Time frame: Baseline and 9 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for May 2028, 23 months after the start.
Of 610 non-industry phase 2 interventional studies under Prostatic Neoplasms, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 86. This study's planned 23 months is below that.
Counting every sponsor, half of 724 studies reached it within 53 months; a quarter within 34 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Cannabidiol
Regionshospital Nordjylland