Cannabidiol for Pain Relief of Patients With End-stage mCRPC

NCT07549256 | Not Yet Recruiting Phase 2

• 2 other identifiers: 2024-513951-33-00F2024-111
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 1.The efficacy of CBD treatment in alleviating pain
2. 2.The efficacy of CBD treatment in reducing the need for non-opioid medications and concomitant therapies
3. 3.The impact of CBD treatment on physical activity and quality of life
4. 4.The anti-inflammatory and potential anti-tumor properties of CBD
5. 5.The safety of CBD treatment

Conditions

Metastatic Castration Resistant Prostate Cancer (mCRPC)

Keywords

Cannabidiol; CBD; Prostate cancer; Adjuvant palliative therapy; Cannabis; Metastatic castration resistant prostate cancer; mCRPC

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 9 weeks

Secondary Outcomes (10)

• Worst pain intensity on numeric rating scale (NRS)

  Baseline and 9 weeks

• Interference of pain on daily functioning

  Baseline and 9 weeks

• Total daily dose of non-opioid analgesics

  Baseline and 9 weeks

• Use of concomitant therapy

  Baseline and 9 weeks

• Quality of life by EORTC-QLQ-C30

  Baseline and 9 weeks

Study Arms (2)

CBD

EXPERIMENTAL

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Cannabidiol DRUG

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

Also known as: CBD

CBD

Placebo DRUG

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

Placebo

Eligibility Criteria

• Gender Eligibility Details: Only biological men
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regionshospital Nordjylland: lead
• Aalborg University Hospital: collaborator

Study Sites (1)

Department of Urology, Aalborg University Hospital

Gistrup, 9260, Denmark

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Marijuana Abuse

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Peter Derek Christian Leutscher

CONTACT

+4524859576; p.leutscher@rn.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Two groups, 1:1 allocation (CBD:Placebo)

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)