Clinical Trials

Alessa is currently conducting several clinical studies of minimally-invasive, drug delivery implantable systems in patients with prostate cancer. Our systems are designed to administer anti-androgen drugs to the tumor in the prostate in a sustained manner without systemic exposure.

Enolen

A Study to Establish the Feasibility of Enolen for the Local Delivery of Enzalutamide in Patients with Prostate Cancer

The primary objectives of this study are to assess whether the Enolen (enzalutamide implant) is safe and delivers anti-androgen medication locally in patients who are planning for radical prostatectomy. The study is being conducted at the NCI. We are currently recruiting men over the age of 35. There are additional inclusion and exclusion criteria. For more details about the study, please go to NCT06257693 or contact EPOO1@alessatherapeutics.com.

Biolen + RT

Biolen System with Radiation Therapy in Patients with Localized Prostate Cancer (Biolen + RT)

This Phase 1 study is being undertaken in collaboration with the Radiation Oncology Branch of the National Cancer Institute (NCI). The study evaluates the feasibility of replacing systemic androgen deprivation therapy (ADT) with Biolen for the targeted local delivery of an anti-androgen agent.

NCI is recruiting patients indicated for ADT in conjunction with radiation therapy to treat localized prostate cancer. There are additional inclusion and exclusion criteria. For more details about the study, please go to NCT04943536 or contact CP002@alessatherapeutics.com. Study participation is approximately 2.5 years, with all study visits at the NCI in Bethesda, Maryland.

Biolen-PC

A Study to Establish the Feasibility of Biolen for the Local Delivery of Bicalutamide in Patients with Prostate Cancer (Biolen-PC)

This study is now complete.  For details please go to NCT04284761 or contact CPOO1@alessatherapeutics.com.