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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Flutamide

Placebo

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

SKCCC at Johns HopkinsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

flutamide

placebo

Arm Description

50mg flutamide prior to brachytherapy and prostatic biopsy

placebo prior to brachytherapy and prostatic biopsy

Outcomes

Primary Outcome Measures

time to DNA double strand break

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03507608

First Posted

April 16, 2018

Last Updated

May 30, 2023

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

1. Study Identification

Unique Protocol Identification Number

NCT03507608

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 10, 2019 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

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

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

flutamide

Arm Type

Experimental

Arm Description

50mg flutamide prior to brachytherapy and prostatic biopsy

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo prior to brachytherapy and prostatic biopsy

Intervention Type

Drug

Intervention Name(s)

Flutamide

Intervention Description

50mg flutamide prior to brachytherapy and prostatic biopsy

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

placebo prior to brachytherapy and prostatic biopsy

Primary Outcome Measure Information:

Title

time to DNA double strand break

Description

Time Frame

6-9 months

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

males with prostate cancer

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Song, M.D.

Phone

410-502-5875

dsong2@jhmi.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Shirley DiPasquale, R.N.

Phone

410-614-1598

sdipasq1@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Song, M.D.

Organizational Affiliation

SKCCC at Johns Hopkins

Official's Role

Principal Investigator

Facility Information:

Facility Name

SKCCC at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Song, M.D.

Phone

410-502-5875

dsong2@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Shirley DiPasquale, R.N

Phone

410-614-1598

sdipasq1@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Srinivasan Yegnasubramanian, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Theodore DeWeese, M.D.

First Name & Middle Initial & Last Name & Degree

Jonathan Coulter, M.D.

First Name & Middle Initial & Last Name & Degree

Angelo Demarzo, M.D.

First Name & Middle Initial & Last Name & Degree

Michael Gorin, M.D.

First Name & Middle Initial & Last Name & Degree

Chen Hu, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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