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

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ClinicalTrials.gov Identifier: NCT03507608
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : October 27, 2022
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Flutamide Other: Placebo Early Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 in a 2:1 ratio (12:6 patients), for an all-trial total of 18 patients receiving flutamide vs 6 patients receiving placebo.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Flutamide

Arms and Interventions
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Arm Intervention/treatment
Experimental: flutamide
50mg flutamide prior to brachytherapy and prostatic biopsy
 Drug: Flutamide
50mg flutamide prior to brachytherapy and prostatic biopsy
Placebo Comparator: placebo
placebo prior to brachytherapy and prostatic biopsy
 Other: Placebo
placebo prior to brachytherapy and prostatic biopsy


Outcome Measures
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Primary Outcome Measures :
  1. time to DNA double strand break [ Time Frame: 6-9 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   males with prostate cancer
Accepts Healthy Volunteers:   No
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.
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): NCT03507608


Contacts
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Contact: Daniel Song, M.D. 410-502-5875 dsong2@jhmi.edu
Contact: Shirley DiPasquale, R.N. 410-614-1598 sdipasq1@jhmi.edu

Locations
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United States, Maryland
SKCCC at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Daniel Song, M.D.    410-502-5875    dsong2@jhmi.edu   
Contact: Shirley DiPasquale, R.N    410-614-1598    sdipasq1@jhmi.edu   
Sub-Investigator: Srinivasan Yegnasubramanian, M.D., Ph.D.         
Sub-Investigator: Theodore DeWeese, M.D.         
Sub-Investigator: Jonathan Coulter, M.D.         
Sub-Investigator: Angelo Demarzo, M.D.         
Sub-Investigator: Michael Gorin, M.D.         
Sub-Investigator: Chen Hu, Ph.D.         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Daniel Song, M.D. SKCCC at Johns Hopkins
More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03507608    
Other Study ID Numbers: J1851
IRB00167697 ( Other Identifier: JHM IRB )
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Flutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents