Efficacy and safety of cannabidiol to patients with advanced prostate cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Regionshospital Nordjylland

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2025-04-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Niels Jensens Grant · The Prostate Cancer Fund by PROPA · The Danish Cancer Association · InMedic Group ApS · Marie Pedersen og Jensine Heibergs Grant

External identifiers

EU CT number

2024-513951-33-00

ClinicalTrials.gov

NCT07549256

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Safety, Efficacy

To assess efficacy of CBD treatment for decreased need of opioids in patients with end-stage metastatic castration resistant prostate cancer

Secondary objectives 5

1. To assess efficacy of CBD treatment for alleviation of pain in patients with end-stage mCRPC.
2. To assess efficacy of CBD treatment for decreased need of non-opioids and concomitant therapies in patients with end-stage mCRPC.
3. To assess impact of CBD treatment on physical activity and quality of life in patients with end-stage mCRPC.
4. To assess pharmacokinetic, anti-inflammatory, and anti-tumorous properties of CBD in patients with end-stage mCRPC.
5. To assess safety of CBD treatment in patients with end-stage mCRPC.

Conditions and MedDRA coding

Prostate cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients diagnosed with mCRPC as documented by increasing prostate specific antigen despite optimally attempted treatment, and no other therapeutic options.
2. Treatment-resistance or ineligible to standardized cancer therapy, incl. medical and surgical castration, chemotherapy, and super hormone treatment
3. Minimum 3 months radiation therapy, if part of treatment
4. Perception of pain
5. Daily use of morphine ATC N02AA01 (10 mg x2) in relief of pain

Exclusion criteria 14

1. 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)
2. Pattern of short duration of response to all previous treatment regimens (<6 months) clinically assessed by the investigator
3. Eastern Cooperative Oncology Group (ECOG) performance status ≥3 or higher (scale 0-5)
4. Change in regular use of conventional pain medication within two weeks prior to baseline visit
5. A history of substance use disorder
6. Hypersensitivity to the active substance
7. Functional liver insufficiency with an alanine transaminase (ALT) >2X ULN and/or bilirubin >2X ULN assessed by a blood sample taken at screening
8. Renal failure with an estimated glomerular filtration rate (eGFR) < 30mL/min/1,73m2 assessed by a blood sample taken at screening
9. Known heart failure - New York Heart Association III – IV (scale I-IV)
10. Known severe chronic obstructive lung disease (Forced Expiratory Volume in the first second (FEV1) <50%)
11. Use of THC-containing cannabis products measured by a urine sample at screening
12. 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
13. Not capable of giving informed consent
14. Not capable of understanding, write or read Danish

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Difference in average total daily dose of opioids (morphine milligram equivalents) during the trial participation with particular focus on the last week prior to end of trial (EOT) comparatively between study participants receiving CBD and placebo, respectively

Secondary endpoints 9

1. Difference in average worst pain intensity on numeric rating scale (NRS) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
2. Difference in interference of pain on daily functioning by Brief Pain Inventory during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.Short Form (BPI-SF) Interference Items
3. Difference in average total daily dose of non-opioid analgesics (e.g., NSAID, paracetamol, secondary analgesics) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
4. Difference in use of concomitant therapy (e.g., radiation, corticosteroids) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
5. Difference in quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core 30 (EORTC-QLQ-C30) and European Organization for Research and Treatment of Cancer Quality of Life Prostate Cancer (EORTC-QLQ-PR25) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
6. Difference in physical activity by average daily steps during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
7. Difference in tumour activity by average serum prostate-specific antigen (PSA) and alkaline phosphatase (ALP) levels during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
8. Difference in inflammation by average serum c-reactive protein (CRP), plasma cytokines and plasma soluble urokinase plasminogen activator receptor (suPAR) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.
9. Difference in safety profile outcomes by laboratory testing of routine blood samples and Common Terminology Criteria for Adverse Events (CTCAE 5.0) during the trial participation with particular focus on the last week prior to EOT comparatively between participants receiving CBD and placebo, respectively.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Regionshospital Nordjylland

Sponsor organisation

Regionshospital Nordjylland

Address

Bispensgade 37

City

Hjoerring

Postcode

9800

Country

Denmark

Scientific contact point

Organisation

Regionshospital Nordjylland

Contact name

Peter Derek Christian Leutscher

Public contact point

Organisation

Regionshospital Nordjylland

Contact name

Peter Derek Christian Leutscher

Third parties 2

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications