Clinical Trials /

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

NCT04943536

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04943536

Trial Eligibility

Document

Title

  • Brief Title: Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
  • Official Title: Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: CP-002
  • NCT ID: NCT04943536

Conditions

  • Prostate Adenocarcinoma

Interventions

DrugSynonymsArms
bicalutamideBiolen+Radiation Therapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Biolen+Radiation TherapyExperimentalLocalized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy
  • bicalutamide

Eligibility Criteria

        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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Feasibility of replacing systemic androgen tx with targeted local delivery
Time Frame:27 months
Safety Issue:
Description: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

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Alessa Therapeutics Inc.

Last Updated

June 29, 2021