The impact of long-term proton pump inhibitors use on the prognosis of patients receiving Androgen-annihilation therapy

Lead Investigator: Yao Zhu, Fudan University Shanghai Cancer Center
Title of Proposal Research: The impact of long-term proton pump inhibitors use on the prognosis of patients receiving Androgen-annihilation therapy
Vivli Data Request: 8577
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Prostate cancer (PCa) is the second most commonly diagnosed cancer and the fifth leading cause of cancer- related deaths among men worldwide, with an estimated 1,414,259 new cancer cases and 375,304 deaths in 2020. Androgen-annihilation therapy (Abiraterone, Enzalutamide, Darolutamide etc. plus prednisone), which reduces the level of male hormones, called androgens, in the body to stop them from fuelling prostate cancer cell growth, has become the standard treatment for castrate-resistant prostate cancer (CRPC) patients. CRPC is a prostate cancer that keeps growing even when the amount of male hormone testosterone is reduced in the body to very low levels.

Proton pump inhibitors (PPI) are a common medication used for the treatment of heartburn and stomach acid-related disorders. They are widely used in the general population including patients with prostate cancer. PPIs affect the acidity of the gastrointestinal tract and this can affect the amount of and the rate at which other medicines reach the blood system. In previous studies PPIs have been shown to improve the outcomes for patients undergoing treatment for bladder cancer, cancer of the oesophagus and non-small cell lung cancer. However, it is not known whether PPIs affect the prognosis of patients having androgen-annihilation therapy.

Our research will include studies looking at three different androgen-annihilation therapies (Abiraterone, Apalutamide and Darolutamide). The studies included also cover patients with prostate cancer which has spread to other parts of the body or metastasized (mCRPC) and patients with prostate cancer which has not spread (nmCRPC), increasing the range of patients who may benefit from the analysis.

Our research, whether the final result is positive or negative, will improve clinicians and patients’ understanding of Androgen-annihilation therapy combined with PPI drugs. If our study shows that PPI drug use is beneficial to the prognosis of prostate cancer patients receiving Androgen-annihilation therapy, we may encourage patients to take PPI at the same time in the future treatment process. In contrast, if the outcome is negative, we may advise patients temporarily stop taking PPIs when receiving Androgen-annihilation therapy. If there is no association between long-term PPI use and the prognosis of Androgen-annihilation therapy, it will also eliminate clinicians’ concern about whether to continue using PPIs when patients are receiving Androgen-annihilation therapy.

Requested Studies:

A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Data Contributor: Bayer
Study ID: NCT02200614
Sponsor ID: 17712