Metastatic Castration Resistant Prostate Cancer (mCRPC)Phase 2ProCanNCT07549256
Cannabidiol for Pain Relief of Patients With End-stage mCRPC
A Phase 2 study testing Cannabidiol in people with Metastatic Castration Resistant Prostate Cancer (mCRPC), run by Regionshospital Nordjylland at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer (mCRPC)
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Jun 2026to Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Urology, Aalborg University Hospital
Gistrup, 9260
About this study
Official title: 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.
Read more
Additionally, the study will assess a range of clinical endpoints in patients with end-stage mCRPC, including:
- The efficacy of CBD treatment in alleviating pain
- The efficacy of CBD treatment in reducing the need for non-opioid medications and concomitant therapies
- The impact of CBD treatment on physical activity and quality of life
- The anti-inflammatory and potential anti-tumor properties of CBD
- 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.
- Being tested
- Cannabidiol, Placebo
- Keywords
- Cannabidiol, CBD, Prostate cancer, Adjuvant palliative therapy, Cannabis, Metastatic castration resistant prostate cancer, mCRPC
- Medical subject headings
- Prostatic Neoplasms, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD
Name: Cannabidiol, 100 mg/ml Dosage: 2 ml three times a day (=600 mg CBD/day) Administration form: oil (oral)
PlaceboDrug
Name: Placebo Dosage: 2 ml three times a day (=0 mg CBD/day) Administration form: oil (oral)
| Study group | Role | What they receive |
|---|---|---|
| CBD | Experimental | Not described Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total daily dose of opioids (morphine milligram equivalents)
Difference in average total daily dose of opioids (morphine milligram equivalents) between study participants receiving CBD and placebo.
Measured: Baseline and 9 weeks
Secondary outcomes (10)
Worst pain intensity on numeric rating scale (NRS)
Difference in average worst pain intensity on numeric rating scale (NRS) between participants receiving CBD and placebo.
Measured: Baseline and 9 weeks
Interference of pain on daily functioning
Difference in interference of pain on daily functioning by Brief Pain Inventory Short Form (BPI-SF) Interference Items between participants receiving CBD and placebo.
Measured: Baseline and 9 weeks
Total daily dose of non-opioid analgesics
Differnece in average total daily dose of non-opioid analgesics (e.g., NSAID, paracetamol, secondary analgesics) between participants receiving CBD and placebo.
Measured: Baseline and 9 weeks
Use of concomitant therapy
Difference in use of concomitant therapy (e.g., radiation, corticosteroids) between participants receiving CBD and placebo.
Measured: Baseline and 9 weeks
Quality of life by EORTC-QLQ-C30
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.
Measured: Baseline and 9 weeks
Quality of life by EORTC-QLQ-PR25
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.
Measured: Baseline and 9 weeks
Physical activity
Difference in physical activity by average daily steps between participants receiving CBD and placebo.
Measured: Baseline and 9 weeks
Tumour activity
Difference in tumour activity by average serum prostate-specific antigen (PSA) and alkaline phosphatase (ALP) levels between participants receiving CBD and placebo.
Measured: Baseline and 9 weeks
Inflammation
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.
Measured: Baseline and 9 weeks
Safety profile outcomes
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.
Measured: Baseline and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start12 Jun 2026
- Primary completion31 May 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups, 1:1 allocation (CBD:Placebo)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Collaborators
- Aalborg University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549256
- Sponsor's protocol ID
- 2024-513951-33-00
- Other IDs
- 2024-513951-33-00, F2024-111
- Acronym
- ProCan
- Status last verified
- Aug 2026
- First submitted
- 10 Apr 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07549256
- Acronym / sponsor ID
- ProCan / 2024-513951-33-00
- Keywords
- Cannabidiol, CBD, Prostate cancer, Adjuvant palliative therapy, Cannabis, Metastatic castration resistant prostate cancer, mCRPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Collaborators
- Aalborg University Hospital
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The efficacy of CBD treatment in alleviating pain
- The efficacy of CBD treatment in reducing the need for non-opioid medications and concomitant therapies
- The impact of CBD treatment on physical activity and quality of life
- The anti-inflammatory and potential anti-tumor properties of CBD
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups, 1:1 allocation (CBD:Placebo)
| Arm | Type | Receives |
|---|---|---|
| CBD | Experimental | Drug: Cannabidiol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: CBDName: Cannabidiol, 100 mg/ml Dosage: 2 ml three times a day (=600 mg CBD/day) Administration form: oil (oral) | Drug | CBD |
| PlaceboName: Placebo Dosage: 2 ml three times a day (=0 mg CBD/day) Administration form: oil (oral) | Drug | Placebo |
Primary outcome
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.
10 secondary outcomes
Worst pain intensity on numeric rating scale (NRS)
Time frame: Baseline and 9 weeks
Interference of pain on daily functioning
Time frame: Baseline and 9 weeks
Total daily dose of non-opioid analgesics
Time frame: Baseline and 9 weeks
Use of concomitant therapy
Time frame: Baseline and 9 weeks
Quality of life by EORTC-QLQ-C30
Time frame: Baseline and 9 weeks
Quality of life by EORTC-QLQ-PR25
Time frame: Baseline and 9 weeks
Physical activity
Time frame: Baseline and 9 weeks
Tumour activity
Time frame: Baseline and 9 weeks
Inflammation
Time frame: Baseline and 9 weeks
Safety profile outcomes
Time frame: Baseline and 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castration Resistant Prostate Cancer (mCRPC)
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 3
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
mCRPC
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Metastatic Castration Resistant Prostate Cancer (mCRPC), run by Regionshospital Nordjylland at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Derek Christian Leutscher (+4524859576, p.leutscher@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total daily dose of opioids (morphine milligram equivalents) (time frame: Baseline and 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.