Full Title
A 2-stage, Lead-in and Randomized, Phase 2, Open-label study of Darolutamide versus Enzalutamide as Monotherapy on Testosterone Levels Change in Men with Hormone-Naïve Prostate Cancer (ARAMON)Purpose
The purpose of this study is to compare the effect of darolutamide and enzalutamide as monotherapies (each given individually) on testosterone levels in people with prostate cancer that was previously treated and who are experiencing a rising PSA level, a possible sign of prostate cancer recurrence. Darolutamide and enzalutamide are androgen receptor inhibitors (ARIs). They block the effects of androgen hormones (male sex hormones that include testosterone) and can slow or stop the growth of prostate cancer cells.
The usual treatment for recurrent prostate cancer is to give androgen deprivation therapy (ADT), which includes drugs that block the production of male hormones, with or without an ARI. Studies have shown that giving ARIs alone, without ADT, may be an effective alternative treatment with fewer side effects due to avoidance of testosterone lowering. In this study, participants will receive darolutamide or enzalutamide without ADT, and testosterone levels and side effects will be monitored. Researchers specifically want to determine the degree to which testosterone increases in response to this treatment, which can also cause side effects.
Participants in the first stage of the study will receive only darolutamide. Patients in the second stage of the study will be randomly assigned to receive darolutamide or enzalutamide, and researchers will compare their effects. Both medications are tablets that are taken orally (by mouth).
Who Can Join
To be eligible for this study, patients must meet several requirements, including:
- Patients must be experiencing a rising PSA (2 ng/ml or greater) despite prior treatment for localized prostate cancer that included surgery and/or radiation therapy.
- Patients may have received prior ADT, but not for longer than 6 months.
- Patients may not have previously received ARIs.
- Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
- This study is for people age 18 and older.
Contact
For more information and to ask about eligibility for this study, please contact the office of Dr. Andrew Laccetti at 646-422-4683.