CBD may cut opioid need in advanced prostate cancer
NCT ID NCT07549256
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 3 times
Summary
This study tests whether cannabidiol (CBD) can reduce the need for strong painkillers (opioids) in people with end-stage prostate cancer that has spread and no longer responds to standard treatments. About 58 participants will receive either CBD or a placebo three times daily for nine weeks. Researchers will track pain levels, quality of life, and side effects to see if CBD offers meaningful relief.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 58 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2026
- Expected to finish
-
Jan 2029
An estimate. End dates often move.
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic castration resistant prostate cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Department of Urology, Aalborg University Hospital
RECRUITINGGistrup, 9260, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer
- Can a Hormone-Blocking drug boost chemotherapy against prostate cancer?
- Can a Cancer-Targeting drug slow advanced prostate cancer?
- Can a smart radiation drug hunt down prostate cancer cells?
- Can a new daily pill slow advanced prostate cancer?