This study will be undertaken to evaluate the feasibility of replacing systemic Androgen
Deprivation Therapy (ADT) with targeted local delivery of an anti-androgen agent alone in
patients in whom ADT + radiation therapy is indicated for the treatment of localized
prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04943536.
This study is a prospective, single-center, single-arm feasibility study. Up to 20
participants will be recruited to assess the safety and patient tolerance of Biolen for
the localized delivery of bicalutamide into the prostate when delivered with
radiotherapy.
At baseline, patients will undergo multiparametric MRI of the prostate. Study
participants will have placement of the drug eluting Biolen implants. At the 8 week
timepoint, participants will undergo repeat multiparametric MRI.
Participants will receive standard of care radiation therapy on weeks 9-11 and will be
followed through 2 years post radiation. A third and fourth multiparametric MRI will be
performed at 6 and 24 months after completion of radiation. Clinical labs and correlative
sample collection and patient quality of life questionnaires will be administered at
follow-up visits. Following completion of follow-up or removal from protocol, patients
may be offered enrollment on long-term follow up protocols.
Lead OrganizationAlessa Therapeutics Inc