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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.

Tracking Information
First Submitted Date  ICMJE June 15, 2021
First Posted Date  ICMJE June 29, 2021
Last Update Posted Date October 8, 2021
Actual Study Start Date  ICMJE October 1, 2021
Estimated Primary Completion Date October 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2021)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2021)
  • Adverse Events [ Time Frame: through 27 months ]
    toxicity of localized delivery of bicalutamide
  • MRI changes [ Time Frame: baseline versus 8 weeks post biolen implantation and 6 months post RT ]
    prostate and tumor volume changes
  • Biochemical progression free survival [ Time Frame: 24 months post RT ]
    rate of biochemical progression free survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
Official Title  ICMJE Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Adenocarcinoma
Intervention  ICMJE
  • Drug: bicalutamide
    localized anti-androgen therapy
  • Radiation: Stereotactic body radiation therapy
    localized radiation therapy
Study Arms  ICMJE Experimental: Biolen+Radiation Therapy
Localized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy
Interventions:
  • Drug: bicalutamide
  • Radiation: Stereotactic body radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2021)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date October 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Deborah Citrin, MD 301-496-5457 citrind@mail.nih.gov
Contact: Theresa Cooley-Zgela, RN 240-764-6207 theresa.cooleyzgela@nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04943536
Other Study ID Numbers  ICMJE CP-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Alessa Therapeutics Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alessa Therapeutics Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Deborah Citrin, MD National Cancer Institute (NCI)
PRS Account Alessa Therapeutics Inc.
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP