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Study on Cannabidiol for Pain Relief in Patients with Advanced Prostate Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of cannabidiol on patients with advanced prostate cancer, specifically those with end-stage metastatic castration-resistant prostate cancer. This type of prostate cancer continues to progress despite treatments that lower testosterone levels. The study aims to evaluate whether cannabidiol can help reduce the need for opioid pain medications in these patients. Cannabidiol, often referred to as CBD, is a chemical compound found in the cannabis plant, and it is being tested in the form of an oral solution. Some participants will receive CBD, while others will receive a placebo, which looks like the CBD solution but does not contain any active ingredients.

The purpose of the study is to assess the effectiveness of CBD in managing pain and reducing the reliance on opioids, which are strong pain-relieving medications. Participants will be randomly assigned to receive either CBD or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The trial will last for a period of nine months, during which participants will be monitored for changes in their pain levels, daily functioning, quality of life, and any side effects they may experience. The study will also look at other factors such as physical activity, tumor activity, and inflammation levels.

Throughout the trial, participants will have regular check-ups to track their progress and ensure their safety. The study will focus on the last week of participation to compare the effects of CBD and placebo on various health outcomes. The ultimate goal is to determine if CBD can provide a safe and effective alternative to opioids for pain management in patients with advanced prostate cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility criteria include a diagnosis of end-stage metastatic castration-resistant prostate cancer, resistance or ineligibility to standard cancer therapies, and a minimum of three months since prostatectomy or radiation therapy.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either cannabidiol or a placebo. This process is double-blinded, meaning neither the participant nor the researchers know which treatment is being administered.

  3. Step 3

    Treatment administration

    The treatment involves taking an oral solution. The specific dosage and frequency are determined by the study protocol and communicated to the participant.

    The duration of the treatment phase is defined by the study protocol, with regular monitoring and adjustments as necessary.

  4. Step 4

    Regular monitoring

    Throughout the trial, regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes measuring pain levels, daily functioning, and quality of life.

    Participants may be required to complete questionnaires and provide blood samples for laboratory testing.

  5. Step 5

    Final assessment

    At the end of the trial, a final assessment is conducted to evaluate the overall impact of the treatment. This includes comparing the average daily dose of opioids and other pain medications used during the trial.

    The final assessment also considers changes in quality of life, physical activity, and tumor activity.

Who can join the trial?

8 criteria

  • Must be a male patient.
  • Must be diagnosed with metastatic castration-resistant prostate cancer (mCRPC). This means the cancer has spread to other parts of the body and is not responding to treatments that lower testosterone.
  • Must have increasing levels of prostate-specific antigen (PSA), a protein produced by the prostate, despite having tried all available treatments.
  • Must not have any other treatment options available.
  • Must be resistant to or not eligible for standard cancer treatments, including medical and surgical castration, chemotherapy, and advanced hormone treatments.
  • Must have had at least 3 months since any prostate surgery or radiation therapy.
  • Must experience pain related to the condition.
  • Must be within the age range of 18 to 65 years old.

Who cannot join the trial?

4 criteria

  • Patients who do not have prostate cancer cannot participate.
  • Only male patients can participate.
  • Patients who are not in the age range of 18 to 65 years cannot participate.
  • Patients who are part of a vulnerable population cannot participate. This means people who might be at a higher risk of harm or exploitation.
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Investigated drugs

Cannabidiol (CBD) is a compound found in cannabis plants. In this trial, it is being tested to see if it can help reduce the need for opioid painkillers in patients with advanced prostate cancer. CBD is thought to have pain-relieving properties, and researchers want to find out if it can help manage pain in a way that allows patients to use fewer opioids, which can have many side effects.

What is already known about the treatment

Cannabidiol – Cannabidiol, commonly known as CBD, is administered orally and is being studied for its potential to relieve pain in patients with advanced prostate cancer. Currently, it is in a phase II clinical trial to evaluate its effectiveness in reducing the need for opioids in these patients. CBD is primarily known for its potential therapeutic effects in managing pain and inflammation. It works by interacting with the body's endocannabinoid system, which plays a role in regulating pain and other functions. CBD is classified as a cannabinoid, a type of compound found in cannabis plants.

Investigated diseases

Prostate cancer – Prostate cancer is a disease where cells in the prostate gland grow uncontrollably. The prostate is a small gland in men that produces seminal fluid. As the cancer progresses, it may spread to nearby tissues or other parts of the body, such as bones and lymph nodes. Early stages often have no symptoms, but advanced stages can cause difficulty urinating, blood in urine, or pelvic discomfort. The disease can progress slowly or more aggressively, depending on the type and stage. Monitoring and understanding the progression is crucial for managing the condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513951-33-00Estimated enrolment58 patientsSponsorRegionshospital Nordjylland

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