NCT05011383 High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
| NCT ID | NCT05011383 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Metastatic Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 51 participants |
| Start Date | 2021-08-31 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 51 participants in total. It began in 2021-08-31 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * 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 * 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 not had an orchiectomy must be maintained on effective GnRH analogue/antagonist therapy * Castration resistant prostate cancer as defined by serum testosterone \< 50 ng/ml and one of the following: * PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart. * Evaluable disease progression by modified RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) * Progression of metastatic bone disease on bone scan with \> 2 new lesions * Presence of metastatic disease on bone or CT scan * Patients must have progressed on 1 next-generation AR-signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide, darolutamide, etc.). * Asymptomatic or minimal cancer related symptoms * Eastern Cooperative Oncology Group (ECOG) Performance Status of \< 2 * Presence of inactivating mutations in ATM, CDK12 or CHEK2 as determined by a CLIA level assay for DNA sequencing. Exclusion Criteria: * 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 * Active or symptomatic viral hepatitis or chronic liver disease AST or ALT \> 2.5 x ULN or total bilirubin \> ULN (unless Gilbert's syndrome is the etiology of hyperbilirubinemia). * Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \<35 % at baseline * Patients with pain attributable to their prostate cancer and requiring the use of opioids. * Tumor causing urinary outlet obstruction that requires catheterization for voiding. Patients that require catheterization to void secondary to benign strictures or other non-cancer causes will be permitted to enroll. * Presence of dementia, psychiatric illness, and/or social situations limiting compliance with study requirements or understanding and/or giving of informed consent. * Any condition(s), medical or otherwise, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained.
Contact & Investigator
Robert B. Montgomery, MD
PRINCIPAL INVESTIGATOR
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Frequently Asked Questions
Who can join the NCT05011383 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Metastatic Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05011383 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05011383 currently recruiting?
Yes, NCT05011383 is actively recruiting participants. Contact the research team at rbmontgo@uw.edu for enrollment information.
Where is the NCT05011383 trial being conducted?
This trial is being conducted at Aurora, United States, West Haven, United States, Gainesville, United States, Orlando, United States and 11 additional locations.
Who is sponsoring the NCT05011383 clinical trial?
NCT05011383 is sponsored by VA Office of Research and Development. The principal investigator is Robert B. Montgomery, MD at VA Puget Sound Health Care System Seattle Division, Seattle, WA. The trial plans to enroll 51 participants.
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