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High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers

Study acronym: VA-BAT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 31, 2026 → Aug 3, 2027
See other at-risk trials from VA Office of Research and Development

Record History

  1. Primary completion pushed from Aug 31, 2026 to Aug 3, 2027 Eligibility criteria expanded, about 22 words · Site details revised at 1 of 17 sites Show 2 more changesShow less
    • Eligibility criteria expanded, about 22 words
    • Site details revised at 1 of 17 sites
  2. Site contacts updated at 1 of 17 sites Eligibility criteria shortened, about 5 wordsv8 Show 1 more changeShow less
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv7
  4. Site details revised at 1 of 17 sitesv6
  5. Study sites: 16 to 17v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 13 to 16v4
  2. Study sites: 10 to 13v3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites revised (10)v2 Show 1 more changeShow less
    • Study sites revised (10)

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will determine whether the presence of DNA repair deficiency in the form of alterations in the genes ATM, CDK12 or CHEK2 predicts for a high likelihood of responding to the use of intermittent high dose testosterone. This therapy may result in responses in tumors which are genetically unstable because of DNA repair deficiency and this is a prospective study to test that hypothesis
Trial Details
NCT Number NCT05011383
Lead Sponsor VA Office of Research and Development
Conditions Metastatic Prostate Cancer
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov