High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers
High-dose Testosterone in Men With Metastatic Castration-resistant Prostate Cancer and ATM or CDK12 Deficiency
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether high-dose testosterone given with breaks between treatments may help prostate cancer with changes in the ATM, CDK12, or CHEK2 genes. These genes help repair DNA. The study is for people whose cancer has spread and has grown despite treatment to lower or block male hormones.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Agree in writing to the study schedule, visits, and use and sharing of health and study information.
- Have prostate adenocarcinoma, a type of cancer confirmed by testing a tissue or cell sample.
- Be on ongoing treatment to lower male hormones, or have had surgery to remove the testicles.
- Have cancer that is growing despite very low testosterone, shown by rising PSA blood tests or worsening scans.
- Have cancer that has spread, shown on a bone scan or CT scan.
- Have cancer that worsened after one newer hormone-blocking drug, such as abiraterone or enzalutamide.
- Have no or few cancer symptoms and be able to do most daily activities.
- Have a DNA test from a certified lab showing a change that stops ATM, CDK12, or CHEK2 from working.
Who can't join
- Be getting active treatment for another cancer.
- Have small cell cancer confirmed by how the cells look, or cancer that has spread to the brain tissue or liver.
- Have active hepatitis caused by a virus, hepatitis symptoms, or long-term liver disease with liver blood tests above the study limits. A bilirubin rise due to Gilbert's syndrome is allowed.
- Have serious heart disease, including a heart attack or artery blood clot in the past 6 months, severe or unstable chest pain, or poor heart pumping strength.
- Have prostate cancer pain that needs opioid pain medicines.
- Have a tumor blocking urine flow that requires a catheter, a tube used to drain urine. Catheters needed for non-cancer causes are allowed.
- Have memory loss, mental illness, or life circumstances that prevent following study rules or understanding and giving consent.
- Have any other condition that the study doctors believe could put you at risk or harm the study results.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 * 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
Study sites (17)
CO
- Rocky Mountain Regional VA Medical Center, Aurora, CO · Aurora, CO 80045Daniel Bowles, MD · Study contact · 720-723-6498 · Daniel.Bowles@va.govMore trials in Aurora
CT
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT · West Haven, CT 06516-2770Herta Chao, MD · Study contact · 203-937-3421 · Herta.Chao@va.govMore trials in West Haven
FL
- North Florida/South Georgia Veterans Health System, Gainesville, FL · Gainesville, FL 32608Jess D Delaune, MD · Study contact · 352-988-7504 · Jess.Delaune@va.govMore trials in Gainesville
- Orlando VA Medical Center, Orlando, FL · Orlando, FL 32803Priya K Gopalan, MD · Study contact · 407-631-2389 · Priya.Gopalan@va.govMore trials in Orlando
GA
- Atlanta VA Medical and Rehab Center, Decatur, GA · Decatur, GA 30033Maria Ribeiro, MD · Study contact · 404-728-7680 · Maria.Ribeiro@va.govMore trials in Decatur
KY
- Robley Rex VA Medical Center, Louisville, KY · Louisville, KY 40206-1433Fred Hendler, MD · Study contact · 502-287-3515More trials in Louisville
MO
- Kansas City VA Medical Center, Kansas City, MO · Kansas City, MO 64128Linda Verkruyse, MD · Study contact · 817-681-7115 · Linda.Verkruyse@va.govMore trials in Kansas City
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO · St Louis, MO 63106Eric Knoche, MD · Study contact · 314-289-6305 · Eric.Knoche@va.govMore trials in St Louis
NC
- Durham VA Medical Center, Durham, NC · Durham, NC 27705Rhonda Bitting, MD · Study contact · 919-286-0411 ext. 17-5441 · Rhonda.Bitting@va.govMore trials in Durham
- Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC · Salisbury, NC 28144Michael Goodman, MD · Study contact · 704-638-9000 ext. 15038More trials in Salisbury
OR
- VA Portland Health Care System, Portland, OR · Portland, OR 97239Julie Graff, MD · Study contact · 503-220-8262 · Julie.Graff@va.govMore trials in Portland
SC
- Ralph H. Johnson VA Medical Center, Charleston, SC · Charleston, SC 29401-5799Steven Savage, MD · Study contact · 843-792-4531 · Stephen.Savage@va.govMore trials in Charleston
TN
- Memphis VA Medical Center, Memphis, TN · Memphis, TN 38104-2127Alva Weir, MD · Study contact · 901-523-8990 ext. 6853More trials in Memphis
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN · Nashville, TN 37212-2637Sally York, MD · Study contact · 615-873-6979More trials in Nashville
TX
- Michael E. DeBakey VA Medical Center, Houston, TX · Houston, TX 77030Anita Sabichi, MD · Study contact · 713-798-3750 · Anita.Sabichi@va.govMore trials in Houston
WA
- VA Puget Sound Health Care System Seattle Division, Seattle, WA · Seattle, WA 98108-1532Robert B Montgomery, MD · Study contact · (206) 277-6878 · Robert.Montgomery@va.govRobert B. Montgomery, MD · Principal investigatorMore trials in Seattle
WI
- William S. Middleton Memorial Veterans Hospital, Madison, WI · Madison, WI 53705-2254David Kosoff, MD · Study contact · 608-256-1901 · David.Kosoff@va.govMore trials in Madison