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NCT03507608 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Completed
Registry status
Early Phase 1
Development phase
25
Enrollment target

NCT03507608: Completed Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

NCT03507608 is a Early Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 25 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03507608, a Early Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

COMPLETED
Registry status
Early Phase 1
Development phase
25 participants
Enrollment target

Study 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.

Primary Outcome

To confirm DNA double-strand breaks occur in prostate cancer tissue following pulse-dose flutamide administration in patients who are androgen suppressed. A value less than 1 indicates a decrease and a value greater than 1 indicates an increase.

Interventions

  • OTHER Placebo
  • DRUG Flutamide

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2019-05-10
Est. Completion 2025-07-03
Phase Early Phase 1

What the finished NCT03507608 record still lists

NCT03507608 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03507608 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03507608 about?

NCT03507608 is a clinical study titled "Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression". 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.

What is the current status of trial NCT03507608?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 25 participants. The study started on 2019-05-10. Estimated completion is 2025-07-03.

What interventions are being tested in trial NCT03507608?

The interventions under investigation include: Placebo (OTHER), Flutamide (DRUG).

Who is sponsoring clinical trial NCT03507608?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03507608's enrollment target sits among peer trials

25 1000th of 2000 higher than 965 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03507608, the US trial registry maintained by the National Library of Medicine. NCT03507608 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.