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

Phase 1

Active, not recruiting

• Conditions: Prostate Adenocarcinoma
• Interventions: Drug: bicalutamide; Radiation: Stereotactic body radiation therapy

• Registration Number: NCT04943536
• Lead Sponsor: Alessa Therapeutics Inc.

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.

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 Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-06-29
• Study Start: 2021-10-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2027-05-15
• Study Completion: 2027-08-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biolen+Radiation Therapy	bicalutamide	Localized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy
Biolen+Radiation Therapy	Stereotactic body radiation therapy	Localized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Cancer Institute; 🇺🇸 Bethesda, Maryland, United States