High dose testosterone treatment for certain prostate cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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
* 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 it's running

• Rocky Mountain Regional VA Medical Center, Aurora, CO
  Aurora, Colorado, United States Recruiting
• VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  West Haven, Connecticut, United States Recruiting
• North Florida/South Georgia Veterans Health System, Gainesville, FL
  Gainesville, Florida, United States Recruiting
• Orlando VA Medical Center, Orlando, FL
  Orlando, Florida, United States Recruiting
• Atlanta VA Medical and Rehab Center, Decatur, GA
  Decatur, Georgia, United States Recruiting
• Robley Rex VA Medical Center, Louisville, KY
  Louisville, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Robert B. Montgomery, MD — VA Puget Sound Health Care System Seattle Division, Seattle, WA
• Study coordinator: Robert B Montgomery, MD
• Email: Robert.Montgomery@va.gov
• Phone: (206) 277-6878

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.