NCT04428203

Epidiolex (CBD) in Patients With Biochemically Recurrent Prostate Cancer

A Phase I/Ib Study on the Safety of Epidiolex in Patients With Prostate Cancer With Rising PSA After Localized Therapy With Either Surgery or Radiation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Zin W Myint · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase I/Ib study is to determine the safety profile of Epidiolex (CBD oil) in biochemically recurrent prostate cancer patients. The study consists of a dose escalation part and dose expansion part. The dose expansion part of the study will use the maximum tolerated dose (MTD) determined in the dose escalation part to assess the activity, safety and tolerability of the investigational product in patients with biochemically recurrent prostate cancer after localized therapy with either surgery or radiation.

Detailed description

Cannabinoids (CBD) have been widely used in medicines for centuries to control pain, nausea or vomiting, and to stimulate appetite, especially in cancer patients. Both cannabinoids receptor 1(CB1) and cannabinoids receptor 2 (CB2) were highly expressed in cultured prostate cancer cells compared to normal prostate cell lines. CBD inhibits tumor growth in xenograft model. Clinicians have been challenged to improve the treatment of biochemically recurrent (BCR) prostate cancer in which prostatic specific antigen (PSA) rises without radiological or clinical progression years after localized treatment (radical prostatectomy or radiation therapy) with or without hormonal treatment. Approximately 50-90% of men with high-risk prostate cancer will experience a BCR. Based on the abovementioned preclinical observations of CBD's effect on prostate cancer and its safety data in two non-cancer populations, a phase I study of CBD in men with biochemically recurrent prostate cancer will be conducted.

Conditions

• Prostate Cancer Recurrent
• Prostate Cancer
• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Epidiolex Oral Liquid Product	600 mg Oral solution
DRUG	Epidiolex Oral Liquid Product	800 mg oral solution
DRUG	Epidiolex Oral Liquid Product	800 mg oral solution

Timeline

• Start date: 2020-08-03
• Primary completion: 2021-08-20
• Completion: 2021-08-20
• First posted: 2020-06-11
• Last updated: 2025-03-05
• Results posted: 2025-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study