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.
Recruiting
Early Phase 1
| Drug | Synonyms | Arms |
|---|---|---|
| Flutamide | flutamide |
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| flutamide | Experimental | 50mg flutamide prior to brachytherapy and prostatic biopsy |
|
| placebo | Placebo Comparator | placebo prior to brachytherapy and prostatic biopsy |
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 |
| 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. |
| Phase: | Early Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
June 16, 2020
