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High dose testosterone treatment for certain prostate cancers

High-dose Testosterone in Men With Metastatic Castration-resistant Prostate Cancer and ATM or CDK12 Deficiency

Phase 2 Interventional VA Office of Research and Development · NCT05011383

This study is testing whether high doses of testosterone can help men with advanced prostate cancer that has certain genetic changes feel better and manage their disease.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment51 (estimated)
Ages18 Years and up
SexMale
SponsorVA Office of Research and Development Federal
Locations17 sites (Aurora, Colorado and 16 other locations)
Trial IDNCT05011383 on ClinicalTrials.gov

What this trial studies

This phase II interventional study aims to evaluate the effectiveness of high dose testosterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have specific genetic alterations in the ATM, CDK12, or CHEK2 genes. The study will involve administering high dose testosterone until disease progression or intolerable side effects occur. Safety and tolerability will be monitored through regular assessments of adverse events, vital signs, and laboratory tests. The study will also assess tumor progression using imaging techniques and PSA levels.

Who should consider this trial

Good fit: Ideal candidates include men over 18 with confirmed adenocarcinoma of the prostate who have castration-resistant metastatic disease and specific genetic mutations.

Not a fit: Patients without the specified genetic alterations or those who are not castration-resistant may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with genetically unstable prostate cancers.

How similar studies have performed: While the approach of using high dose testosterone in this context is novel, similar studies have explored testosterone therapy in prostate cancer with varying results.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Aurora, Colorado and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Prostate CancerProstatic Neoplasms
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.