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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03507608
• Other study ID #: J1851
• Secondary ID: IRB00167697
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 10, 2019
• Est. completion date: December 2028

Study information

• Verified date: May 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Daniel Song, M.D.
• Phone: 410-502-5875
• Email: dsong2[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Drug:
• Flutamide
50mg flutamide prior to brachytherapy and prostatic biopsy

Other:
• Placebo
placebo prior to brachytherapy and prostatic biopsy

Locations

Country	Name	City	State
United States	SKCCC at Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6-9 months