Clinical Trials /

Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression

NCT03507608

Description:

This is a prospective, single-center, two-phase study to assess the efficacy of single pulsed-dose flutamide in creating double strand breaks (DSBs) in prostate cancer within patients receiving central androgen suppression and brachytherapy.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression
  • Official Title: Randomized Trial Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression

Clinical Trial IDs

  • ORG STUDY ID: J1851
  • SECONDARY ID: IRB00167697
  • NCT ID: NCT03507608

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
Flutamideflutamide

Purpose

This is a prospective, single-center, two-phase study to assess the efficacy of single pulsed-dose flutamide in creating double strand breaks (DSBs) in prostate cancer within patients receiving central androgen suppression and brachytherapy.

Detailed Description

      This is a prospective, single-center, two-phase study to assess the efficacy of single
      pulsed-dose flutamide in creating DSBs (double strand breaks) in prostate cancer within
      patients receiving central androgen suppression and brachytherapy. The initial phase is a
      6-patient single-arm run-in phase to test feasibility and rule out futility of the
      intervention. All patients within the run-in phase will receive 50mg flutamide prior to
      brachytherapy and prostatic biopsy. If futility is ruled out (>1 patients with DSBs on
      biopsy), then accrual will continue in the randomized, double-blind phase. Subjects will be
      randomized in a 2:1 ratio (12:6 patients), for an all-trial total of 18 patients receiving
      flutamide vs 6 patients receiving placebo.
    

Trial Arms

NameTypeDescriptionInterventions
flutamideExperimental50mg flutamide prior to brachytherapy and prostatic biopsy
  • Flutamide
placeboPlacebo Comparatorplacebo prior to brachytherapy and prostatic biopsy

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Histologically confirmed prostate cancer
    
              -  At least one biopsy core with Gleason 7 or higher disease
    
              -  The patient has decided to undergo brachytherapy plus androgen suppression as
                 treatment modality for his prostate cancer (with or without supplemental external beam
                 radiation)
    
              -  Suitable volume of disease for biopsy:
    
              -  clinically palpable disease corresponding to (ipsilateral to) any involved core on
                 biopsy
    
              -  Signed study-specific consent form prior to registration
    
            Exclusion Criteria:
    
              -  Known hypersensitivity or allergic response to flutamide
    
              -  Severe hepatic impairment
    
              -  Major medical or psychiatric illness which, in the investigator's opinion, would
                 prevent completion of treatment and would interfere with follow up.
          
    Maximum Eligible Age:100 Years
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:time to DNA double strand break
    Time Frame:6-9 months
    Safety Issue:
    Description:To confirm DNA double strand breaks occur in prostate cancer tissue following pulse-dose flutamide administration in patients who are androgen suppressed, as compared to control patients receiving placebo.

    Details

    Phase:Early Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Last Updated

    June 4, 2019