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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
VA Office of Research and Development
Study ID
NCT05011383
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High dose testosterone — DRUG
    High dose testosterone is administered subcutaneously once monthly until progression or toxicity

Study Details

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

Key Dates

Start date
Aug 31, 2021
Status verified
Jul 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
51 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ATM
    Patients with castration resistant prostate cancer which contains ATM alterations are treated with high dose testosterone
  • Experimental: CDK12
    Patients with castration resistant prostate cancer which contains CDK12 alterations are treated with high dose testosterone
  • Experimental: CHEK2
    Patients with castration resistant prostate cancer which contains CHEK2 alterations are treated with high dose testosterone

Primary Outcome Measure

PSA response [ Time Frame: 12 weeks ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Rocky Mountain Regional VA Medical Center, Aurora, COAuroraColorado80045
Daniel Bowles, MD
[email protected]
720-723-6498
VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest HavenConnecticut06516-2770
Herta Chao, MD
[email protected]
203-937-3421
North Florida/South Georgia Veterans Health System, Gainesville, FLGainesvilleFlorida32608
Jess D Delaune, MD
[email protected]
352-988-7504
Orlando VA Medical Center, Orlando, FLOrlandoFlorida32803
Priya K Gopalan, MD
[email protected]
407-631-2389
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033
Maria Ribeiro, MD
[email protected]
404-728-7680
Robley Rex VA Medical Center, Louisville, KYLouisvilleKentucky40206-1433
Fred Hendler, MD
502-287-3515
Kansas City VA Medical Center, Kansas City, MOKansas CityMissouri64128
Linda Verkruyse, MD
[email protected]
817-681-7115
St. Louis VA Medical Center John Cochran Division, St. Louis, MOSt LouisMissouri63106
Eric Knoche, MD
[email protected]
314-289-6305
Durham VA Medical Center, Durham, NCDurhamNorth Carolina27705
Rhonda Bitting, MD
[email protected]
919-286-0411
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NCSalisburyNorth Carolina28144
Michael Goodman, MD
704-638-9000
VA Portland Health Care System, Portland, ORPortlandOregon97239
Julie Graff, MD
[email protected]
503-220-8262
Ralph H. Johnson VA Medical Center, Charleston, SCCharlestonSouth Carolina29401-5799
Steven Savage, MD
[email protected]
843-792-4531
Memphis VA Medical Center, Memphis, TNMemphisTennessee38104-2127
Alva Weir, MD
901-523-8990
Tennessee Valley Healthcare System Nashville Campus, Nashville, TNNashvilleTennessee37212-2637
Sally York, MD
615-873-6979
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030
Anita Sabichi, MD
[email protected]
713-798-3750
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattleWashington98108-1532
Robert B Montgomery, MD
[email protected]
206-277-6878
Robert B. Montgomery, MD (PRINCIPAL_INVESTIGATOR)
William S. Middleton Memorial Veterans Hospital, Madison, WIMadisonWisconsin53705-2254
David Kosoff, MD
[email protected]
608-256-1901

Find similar trials in Aurora, CO

By research site
Rocky Mountain Regional VA Medical Center, Aurora, CO· Aurora, COVA Connecticut Healthcare System West Haven Campus, West Haven, CT· West Haven, CTNorth Florida/South Georgia Veterans Health System, Gainesville, FL· Gainesville, FLOrlando VA Medical Center, Orlando, FL· Orlando, FLAtlanta VA Medical and Rehab Center, Decatur, GA· Decatur, GARobley Rex VA Medical Center, Louisville, KY· Louisville, KY

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