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Efficacy and safety of cannabidiol to patients with advanced prostate cancer
EU CTIS ID: 2024-513951-33-00
What this study is testing
To assess efficacy of CBD treatment for decreased need of opioids in patients with end-stage metastatic castration resistant prostate cancer
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients diagnosed with mCRPC as documented by increasing prostate specific antigen 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 radiation therapy, if part of treatment
- Perception of pain
- Daily use of morphine ATC N02AA01 (10 mg x2) in relief of pain
You likely can't join if
- 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)
- Known severe chronic obstructive lung disease (Forced Expiratory Volume in the first second (FEV1) <50%)
- 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
- Not capable of giving informed consent
- Not capable of understanding, write or read Danish
See the full eligibility criteria
- Patients diagnosed with mCRPC as documented by increasing prostate specific antigen 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 radiation therapy, if part of treatment
- Perception of pain
- Daily use of morphine ATC N02AA01 (10 mg x2) in relief of pain
- 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)
- Known severe chronic obstructive lung disease (Forced Expiratory Volume in the first second (FEV1) <50%)
- 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
- Not capable of giving informed consent
- Not capable of understanding, write or read Danish
- 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 or higher (scale 0-5)
- Change in regular use of conventional pain medication within two weeks prior to baseline visit
- A history of substance use disorder
- Hypersensitivity to the active substance
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.