Early Phase 1
Completed N=6
Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression
Source: ClinicalTrials.gov NCT03507608 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: Fold-change Post Flutamide Exposure — 5.860 Fold-change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fold-change Post Flutamide Exposure |
5.860 | — |
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. Informational only — not medical advice.