Metastatic Castration Resistant Prostate Cancer (mCRPC)
Conditions
Keywords
Cannabidiol, CBD, Prostate cancer, Adjuvant palliative therapy, Cannabis, Metastatic castration resistant prostate cancer, mCRPC
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. 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.
Interventions
DRUGCannabidiol
Name: Cannabidiol, 100 mg/ml Dosage: 2 ml three times a day (=600 mg CBD/day) Administration form: oil (oral)
DRUGPlacebo
Name: Placebo Dosage: 2 ml three times a day (=0 mg CBD/day) Administration form: oil (oral)
Sponsors
Regionshospital Nordjylland
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Two groups, 1:1 allocation (CBD:Placebo)
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total daily dose of opioids (morphine milligram equivalents) | Baseline and 9 weeks | Difference in average total daily dose of opioids (morphine milligram equivalents) between study participants receiving CBD and placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worst pain intensity on numeric rating scale (NRS) | Baseline and 9 weeks | Difference in average worst pain intensity on numeric rating scale (NRS) between participants receiving CBD and placebo. |
| Interference of pain on daily functioning | Baseline and 9 weeks | Difference in interference of pain on daily functioning by Brief Pain Inventory Short Form (BPI-SF) Interference Items between participants receiving CBD and placebo. |
| Total daily dose of non-opioid analgesics | Baseline and 9 weeks | Differnece in average total daily dose of non-opioid analgesics (e.g., NSAID, paracetamol, secondary analgesics) between participants receiving CBD and placebo. |
| Use of concomitant therapy | Baseline and 9 weeks | Difference in use of concomitant therapy (e.g., radiation, corticosteroids) between participants receiving CBD and placebo. |
| Quality of life by EORTC-QLQ-C30 | Baseline and 9 weeks | 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. |
| Quality of life by EORTC-QLQ-PR25 | Baseline and 9 weeks | 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. |
| Physical activity | Baseline and 9 weeks | Difference in physical activity by average daily steps between participants receiving CBD and placebo. |
| Tumour activity | Baseline and 9 weeks | Difference in tumour activity by average serum prostate-specific antigen (PSA) and alkaline phosphatase (ALP) levels between participants receiving CBD and placebo. |
| Inflammation | Baseline and 9 weeks | 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. |
| Safety profile outcomes | Baseline and 9 weeks | 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. |
Countries
Denmark
Contacts
CONTACTPeter Derek Christian Leutscher
Outcome results
None listed