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

Last updated: May 9, 2025
Sponsor: Alessa Therapeutics Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Prostate Cancer

Adenocarcinoma

Treatment

Stereotactic body radiation therapy

bicalutamide

Clinical Study ID

NCT04943536
CP-002
ZIABC010850
ZIABC011552
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with biopsy proven localized prostate cancer in whom prostate radiation andADT 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 toreceive systemic ADT, OR

  3. NCCN high risk prostate cancer due to Prostate Specific Antigen (PSA) > 20 ANDrefuses to receive systemic ADT.

  • Age >18 years.

Exclusion

Exclusion Criteria:

  • NCCN high risk patients eligible for treatment with systemic ADT who do not refusesystemic 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 withcontra-indications to MRI, such as cardiac pacemakers, non-compatible intracranialvascular clips, etc.

  • Use of 5 alpha reductase inhibitors (e.g. Finasteride or Dutasteride) within 3months of screening or total use within the last two years prior to screening of > 3months.

  • Prostate volume more than 80 cc at prior MRI imaging.

  • International Prostate Symptom Score ≥ 20.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Stereotactic body radiation therapy
Phase: 1
Study Start date:
October 01, 2021
Estimated Completion Date:
August 15, 2027

Study 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.

Connect with a study center

  • National Cancer Institute

    Bethesda, Maryland 20894
    United States

    Site Not Available

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