search
Back to results

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

Primary Purpose

Prostate Adenocarcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bicalutamide
Stereotactic body radiation therapy
Sponsored by
Alessa Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biolen+Radiation Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Adverse Events
toxicity of localized delivery of bicalutamide
MRI changes
prostate and tumor volume changes
Biochemical progression free survival
rate of biochemical progression free survival

Full Information

First Posted
June 15, 2021
Last Updated
October 1, 2021
Sponsor
Alessa Therapeutics Inc.
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04943536
Brief Title
Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
Acronym
Biolen + RT
Official Title
Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alessa Therapeutics Inc.
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biolen+Radiation Therapy
Arm Type
Experimental
Arm Description
Localized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy
Intervention Type
Drug
Intervention Name(s)
bicalutamide
Intervention Description
localized anti-androgen therapy
Intervention Type
Radiation
Intervention Name(s)
Stereotactic body radiation therapy
Intervention Description
localized radiation therapy
Primary Outcome Measure Information:
Title
Feasibility of replacing systemic androgen tx with targeted local delivery
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.
Time Frame
27 months
Secondary Outcome Measure Information:
Title
Adverse Events
Description
toxicity of localized delivery of bicalutamide
Time Frame
through 27 months
Title
MRI changes
Description
prostate and tumor volume changes
Time Frame
baseline versus 8 weeks post biolen implantation and 6 months post RT
Title
Biochemical progression free survival
Description
rate of biochemical progression free survival
Time Frame
24 months post RT

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Citrin, MD
Phone
301-496-5457
Email
citrind@mail.nih.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Theresa Cooley-Zgela, RN
Phone
240-764-6207
Email
theresa.cooleyzgela@nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Citrin, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20894
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Citrin, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs