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High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
NCT05011383 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- DRUG High dose testosterone
Study Locations (17)
Florida
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville
- Orlando VA Medical Center, Orlando, FL — Orlando
Missouri
- Kansas City VA Medical Center, Kansas City, MO — Kansas City
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis
North Carolina
- Durham VA Medical Center, Durham, NC — Durham
- Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC — Salisbury
Tennessee
- Memphis VA Medical Center, Memphis, TN — Memphis
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville
Colorado
- Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora
Connecticut
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur
Kentucky
- Robley Rex VA Medical Center, Louisville, KY — Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2021-08-31 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05011383
The ClinicalTrials.gov registry entry for NCT05011383 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metastatic Prostate Cancer appearing as the primary indexed condition, and to 1 intervention — of which High dose testosterone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05011383 reports 17 study locations spanning 13 distinct geographic areas — top geographies include Florida, Missouri, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05011383 about?
NCT05011383 is a clinical study titled "High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers". 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 uns...
What is the current status of trial NCT05011383?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2021-08-31. Estimated completion is 2027-08-31.
What conditions does trial NCT05011383 study?
This clinical trial studies the following conditions: Metastatic Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05011383?
The interventions under investigation include: High dose testosterone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05011383?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05011383 being conducted?
This trial has 17 study locations across Colorado, Connecticut, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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