Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer (BiolenRT)

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 Overview

• Status: Active, not recruiting
• Conditions: Prostate Adenocarcinoma
• Intervention / Treatment: Drug: bicalutamide; Radiation: Stereotactic body radiation therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20894
      • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with biopsy proven localized prostate cancer in whom prostate radiation and ADT is appropriate therapy (such as Intermediate Risk localized prostate cancer)
• Patients must have at least 1 MRI detected; biopsy proven prostate cancer.

• Patients diagnosed as one of the following:

  1. National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer, OR
  2. NCCN high risk prostate cancer due to Gleason Grade 4 or 5 AND refuses to receive systemic ADT, OR
  3. NCCN high risk prostate cancer due to Prostate Specific Antigen (PSA) > 20 AND refuses to receive systemic ADT.
• Age >18 years.

Exclusion Criteria:

• NCCN high risk patients eligible for treatment with systemic ADT who do not refuse systemic ADT.
• Patients receiving prior radiotherapy or surgery for prostate cancer.
• Patients receiving prior or ongoing ADT.
• Study participant unwilling or unable to undergo MRI, including patients with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.
• Use of 5 alpha reductase inhibitors (e.g. Finasteride or Dutasteride) within 3 months of screening or total use within the last two years prior to screening of > 3 months.
• Prostate volume more than 80 cc at prior MRI imaging.
• International Prostate Symptom Score ≥ 20.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biolen+Radiation Therapy; Localized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy	Drug: bicalutamide; localized anti-androgen therapy; Radiation: Stereotactic body radiation therapy; localized radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of replacing systemic androgen tx with targeted local delivery	Ability to successfully implant the prostate with Biolen and a lack of implant toxicity that interferes with the capacity to complete intended radiation therapy.	27 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	toxicity of localized delivery of bicalutamide	through 27 months
MRI changes	prostate and tumor volume changes	baseline versus 8 weeks post biolen implantation and 6 months post RT
Biochemical progression free survival	rate of biochemical progression free survival	24 months post RT

Collaborators and Investigators

• Sponsor: Alessa Therapeutics Inc.
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Deborah Citrin, MD, National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Estimated): April 24, 2027
• Study Completion (Estimated): August 15, 2027

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Stereotaxic Techniques; Neurosurgical Procedures; Radiosurgery; bicalutamide
• Other Study ID Numbers: CP-002; ZIABC010850 (U.S. NIH Grant/Contract); ZIABC011552 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No