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CBD may cut opioid need in advanced prostate cancer

NCT ID NCT07549256

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Gistrup, 9260, Denmark

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