High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
ConditionMetastatic Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorVA Office of Research and Development
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information
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 not had an orchiectomy must be maintained on effective GnRH analogue/antagonist therapy
PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart.
Disqualifiers
Currently receiving active therapy for other neoplastic disorders will not be eligible
Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical evidence of neuroendrocrine differentiation without morphologic evidence is not exclusionary)
Known parenchymal brain metastasis
Liver metastases
Trial design
Design model
Single group
Treatments tested in this trial
High dose testosterone
DrugHigh dose testosterone is administered subcutaneously once monthly until progression or toxicity
Treatment groups
51 Participants
are divided into 3 treatment groupsGroup A: ATMExperimental treatment 1 intervention
Group B: CDK12Experimental treatment 1 intervention
Group C: CHEK2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PSA response
PSA response as measured by a 50% decline from baseline maintained for 12 weeks
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov