Early Phase 1
N=6
Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03507608 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Fold-change Post Flutamide Exposure — 5.860 Fold-change
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Flutamide (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fold-change Post Flutamide Exposure |
5.860 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03507608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.