Cannabidiol for Pain Relief in End-Stage Metastatic Castration-Resistant Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial evaluates CBD versus placebo in patients with end-stage metastatic castration-resistant prostate cancer who have limited treatment options. Participants receive 200 mg of CBD or placebo three times daily for nine weeks, with assessments at baseline, midpoint, and end of treatment. Outcomes include opioid-sparing effects, reduction in non-opioid medications, physical activity, quality of life, and potential anti-inflammatory and anti-tumor signals, alongside safety data. The trial is conducted at Aalborg University Hospital, Department of Urology, with Regionshospital Nordjylland as the lead sponsor and Aalborg University Hospital as a collaborator.

Why it matters

Who can join: the full rules

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.
* Opioid-requiring 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 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.

Where it's running

• Department of Urology, Aalborg University Hospital
  Gistrup, Denmark Recruiting

Study contacts

• Study coordinator: Peter Derek Christian Leutscher
• Email: p.leutscher@rn.dk
• Phone: +4524859576

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Xaluritamig in adults with metastatic castration-resistant prostate cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.