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Cannabidiol for Pain Relief of Patients With End-stage mCRPC

NCT07549256 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-04-24

No results posted yet for this study

Summary

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.

Conditions

  • Metastatic Castration Resistant Prostate Cancer (mCRPC)

Interventions

DRUG

Cannabidiol

Name: Cannabidiol, 100 mg/ml Dosage: 2 ml three times a day (=600 mg CBD/day) Administration form: oil (oral)

DRUG

Placebo

Name: Placebo Dosage: 2 ml three times a day (=0 mg CBD/day) Administration form: oil (oral)

Sponsors & Collaborators

  • Aalborg University Hospital

    collaborator OTHER

  • Regionshospital Nordjylland

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-05-31
Completion
2029-01-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07549256 on ClinicalTrials.gov