Cannabidiol for Pain Relief of Patients With End-stage mCRPC (NCT07549256) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Cannabidiol for Pain Relief of Patients With End-stage mCRPC
Denmark58 participantsStarted 2026-06-01
Plain-language summary
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:
1. The efficacy of CBD treatment in alleviating pain
2. The efficacy of CBD treatment in reducing the need for non-opioid medications and concomitant therapies
3. The impact of CBD treatment on physical activity and quality of life
4. The anti-inflammatory and potential anti-tumor properties of CBD
5. The safety of CBD treatment
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.
Who can participate
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Perception of pain
* Daily use of Morphine (ATC: N02AA01) (10mgx2) in relief of pain.
Exclusion Criteria:
* 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 f…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total daily dose of opioids (morphine milligram equivalents)