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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04943536
Recruitment Status : Recruiting
First Posted : June 29, 2021
Last Update Posted : October 8, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alessa Therapeutics Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Drug: bicalutamide Radiation: Stereotactic body radiation therapy Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of replacing systemic androgen tx with targeted local delivery [ Time Frame: 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 :
  1. Adverse Events [ Time Frame: through 27 months ]
    toxicity of localized delivery of bicalutamide

  2. MRI changes [ Time Frame: baseline versus 8 weeks post biolen implantation and 6 months post RT ]
    prostate and tumor volume changes

  3. Biochemical progression free survival [ Time Frame: 24 months post RT ]
    rate of biochemical progression free survival


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04943536


Contacts
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Contact: Deborah Citrin, MD 301-496-5457 citrind@mail.nih.gov
Contact: Theresa Cooley-Zgela, RN 240-764-6207 theresa.cooleyzgela@nih.gov

Locations
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United States, Maryland
National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20894
Principal Investigator: Deborah Citrin, MD         
Sponsors and Collaborators
Alessa Therapeutics Inc.
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Deborah Citrin, MD National Cancer Institute (NCI)
More Information
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Responsible Party: Alessa Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04943536    
Other Study ID Numbers: CP-002
First Posted: June 29, 2021    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bicalutamide
 Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents