NCT03507608CompletedEarly phase 1
Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression
Randomized Trial Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression
Source: ClinicalTrials.gov · Last updated 16 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 16 Apr 2018
- Start date
- 10 May 2019
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Prostate cancer
- NCT number
- NCT03507608
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 25
- From 10 May 2019 to the primary completion date, 30 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SKCCC at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.