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Clinical Trials

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Alessa is currently conducting several clinical studies of Biolen® PC, a minimally-invasive, drug delivery implantable system in patients with prostate cancer. Biolen PC is designed to administer anti-androgen drugs to the tumor in the prostate through a sustained, localized system – without systemic exposure.

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Biolen-PC

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

The primary objectives of this first-in-man feasibility study are to assess the safety and patient tolerance of Biolen. The study is being conducted at several clinical institutions in Australia and New Zealand. 

We are currently recruiting men over the age of 35 who:

  • Have biopsy confirmed prostate cancer with a Gleason score of 3+4 or higher
  • Are scheduled to undergo surgery to remove the prostate
  • Are willing and able to undergo MRI follow-up imaging

There are additional inclusion and exclusion criteria. For more details about the study, please go to NCT04284761 or contact CP001@alessatherapeutics.com.

Biolen + RT

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

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

NCI will be recruiting patients indicated for ADT in conjunction with radiation therapy to treat localized prostate cancer. Participants must:

  • Have biopsy confirmed intermediate or high-risk prostate cancer
  • Are willing and able to undergo MRI follow-up imaging

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.