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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • 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

  • 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

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
Intervention / Treatment
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

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

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

Regionshospital Nordjylland

Collaborators

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)

June 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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