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NCT05011383 · ClinicalTrials.gov registry record · Phase 2
High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
A Phase 2 study of Metastatic Prostate Cancer, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 17
- Study locations
NCT05011383: Recruiting Phase 2 study of Metastatic Prostate Cancer, sponsored by VA Office of Research and Development.
NCT05011383 is a Phase 2 study of Metastatic Prostate Cancer that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 51 participants, below the 185-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target (72% lower). The trial reports 17 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05011383, a Phase 2 study of Metastatic Prostate Cancer, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 17
- Study locations
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
Primary Outcome
PSA response as measured by a 50% decline from baseline maintained for 12 weeks
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 |
What NCT05011383 shows while recruiting
NCT05011383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 185-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target (72% lower).
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.
NCT05011383 lists 17 locations in 13 states (Florida, Missouri, North Carolina).
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.
What interventions are being tested in trial NCT05011383?
The interventions under investigation include: High dose testosterone (DRUG).
Who is sponsoring clinical trial NCT05011383?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05011383's enrollment target sits among peer trials
51 25th of 41 higher than 17 of 41 other Metastatic Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Prostate Cancer 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.
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