Actively Recruiting
High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
Led by VA Office of Research and Development · Updated on 2025-07-09
51
Participants Needed
17
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to follow dosing schedule, attend all visits, and allow use of health and trial data
- Male aged over 18 years
- Confirmed adenocarcinoma of the prostate by tissue biopsy
- Currently on gonadal androgen deprivation therapy or have had an orchiectomy
- Castration-resistant prostate cancer defined by serum testosterone below 50 ng/ml and either rising PSA on two occasions, measurable disease progression, or bone disease progression
- Presence of metastatic disease on bone or CT scan
- Progressed after treatment with at least one next-generation AR-signaling inhibitor
- Asymptomatic or have minimal cancer-related symptoms
- ECOG Performance Status less than 2
- Have inactivating mutations in ATM, CDK12, or CHEK2 confirmed by DNA sequencing assay
You will not qualify if you...
- Currently receiving treatment for other cancers
- Small cell carcinoma histology
- Known brain metastases
- Liver metastases
- Active or symptomatic viral hepatitis or significant liver disease
- Significant heart disease such as recent heart attack or severe angina
- Use of opioids for prostate cancer pain
- Urinary obstruction caused by tumor requiring catheterization
- Dementia, psychiatric illness, or social issues limiting consent or compliance
- Any condition considered by investigators to risk patient safety or study data integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045
Actively Recruiting
2
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516-2770
Actively Recruiting
3
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608
Actively Recruiting
4
Orlando VA Medical Center, Orlando, FL
Orlando, Florida, United States, 32803
Actively Recruiting
5
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
Actively Recruiting
6
Robley Rex VA Medical Center, Louisville, KY
Louisville, Kentucky, United States, 40206-1433
Actively Recruiting
7
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, United States, 64128
Actively Recruiting
8
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, United States, 63106
Actively Recruiting
9
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
Actively Recruiting
10
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, United States, 28144
Actively Recruiting
11
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
Actively Recruiting
12
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
Actively Recruiting
13
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, United States, 38104-2127
Actively Recruiting
14
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
Actively Recruiting
15
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Not Yet Recruiting
16
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108-1532
Actively Recruiting
17
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, United States, 53705-2254
Actively Recruiting
Research Team
R
Robert B Montgomery, MD
CONTACT
E
Elahe Mostaghel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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