Cannabidiol for Pain Relief of Patients With End-stage mCRPC (ProCan)

April 17, 2026 updated by: Regionshospital Nordjylland

Efficacy and Safety of Cannabidiol for Pain Relief of Patients With End-stage Metastatic Castration Resistant Prostate Cancer - a Randomised Double-blinded Placebo-controlled Phase II Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Peter Derek Christian Leutscher
  • Phone Number: +4524859576
  • Email: p.leutscher@rn.dk

Study Locations

  • Denmark
      • Gistrup, Denmark, 9260
        • Department of Urology, Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Name: Placebo Dosage: 2 ml three times a day (=0 mg CBD/day) Administration form: oil (oral)
Experimental: CBD
Drug: Cannabidiol
Name: Cannabidiol, 100 mg/ml Dosage: 2 ml three times a day (=600 mg CBD/day) Administration form: oil (oral)
Other Names:
  • CBD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total daily dose of opioids (morphine milligram equivalents)
Time Frame: Baseline and 9 weeks
Difference in average total daily dose of opioids (morphine milligram equivalents) between study participants receiving CBD and placebo.
Baseline and 9 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Worst pain intensity on numeric rating scale (NRS)
Time Frame: Baseline and 9 weeks
Difference in average worst pain intensity on numeric rating scale (NRS) between participants receiving CBD and placebo.
Baseline and 9 weeks
Interference of pain on daily functioning
Time Frame: Baseline and 9 weeks
Difference in interference of pain on daily functioning by Brief Pain Inventory Short Form (BPI-SF) Interference Items between participants receiving CBD and placebo.
Baseline and 9 weeks
Total daily dose of non-opioid analgesics
Time Frame: Baseline and 9 weeks
Differnece in average total daily dose of non-opioid analgesics (e.g., NSAID, paracetamol, secondary analgesics) between participants receiving CBD and placebo.
Baseline and 9 weeks
Use of concomitant therapy
Time Frame: Baseline and 9 weeks
Difference in use of concomitant therapy (e.g., radiation, corticosteroids) between participants receiving CBD and placebo.
Baseline and 9 weeks
Quality of life by EORTC-QLQ-C30
Time Frame: Baseline and 9 weeks

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.
Baseline and 9 weeks
Quality of life by EORTC-QLQ-PR25
Time Frame: Baseline and 9 weeks
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.
Baseline and 9 weeks
Physical activity
Time Frame: Baseline and 9 weeks
Difference in physical activity by average daily steps between participants receiving CBD and placebo.
Baseline and 9 weeks
Tumour activity
Time Frame: Baseline and 9 weeks
Difference in tumour activity by average serum prostate-specific antigen (PSA) and alkaline phosphatase (ALP) levels between participants receiving CBD and placebo.
Baseline and 9 weeks
Inflammation
Time Frame: Baseline and 9 weeks
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.
Baseline and 9 weeks
Safety profile outcomes
Time Frame: Baseline and 9 weeks
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.
Baseline and 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regionshospital Nordjylland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aalborg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-513951-33-00 (Ctis)
  • F2024-111 (Other Identifier: Forskningsanmeldelse Region Nordjylland - Registrering af forskningsprojekter)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Conditions

Rare Diseases

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Dietary Supplements

Sponsor/Collaborators

Locations

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