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

NCT04943536 | Active Not Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: CP-002ZIABC010850ZIABC011552
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adverse Events

  through 27 months

• MRI changes

  baseline versus 8 weeks post biolen implantation and 6 months post RT

• Biochemical progression free survival

  24 months post RT

Study Arms (1)

Biolen+Radiation Therapy

EXPERIMENTAL

Localized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy

Drug: bicalutamide; Radiation: Stereotactic body radiation therapy

Interventions

bicalutamide DRUG

localized anti-androgen therapy

Biolen+Radiation Therapy

Stereotactic body radiation therapy RADIATION

localized radiation therapy

Biolen+Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alessa Therapeutics Inc.: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

National Cancer Institute

Bethesda, Maryland, 20894, United States

Location

MeSH Terms

Interventions

bicalutamide; Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Deborah Citrin, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 29, 2021
• Study Start: December 7, 2021
• Primary Completion (Estimated): April 24, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)