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 unstable because of DNA repair deficiency and this is a prospective study to test that hypothesis

Trial Details

NCT ID
NCT05011383
Phase
PHASE2
Sponsor
VA Office of Research and Development
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • High dose testosterone
Locations (sample)
  • Aurora, Colorado, United States|39.72943,-104.83192
  • West Haven, Connecticut, United States|41.27065,-72.94705
  • Gainesville, Florida, United States|29.65163,-82.32483
  • Orlando, Florida, United States|28.53834,-81.37924
  • Decatur, Georgia, United States|33.77483,-84.29631

Key Eligibility Criteria

  • Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and rel…
  • Male age \> 18 years
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy. Patients who have no…

For full eligibility, visit ClinicalTrials.gov.

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