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Metastatic Prostate CancerPhase 2VA-BATNCT05011383

High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers

A Phase 2 study testing High dose testosterone in people with Metastatic Prostate Cancer, run by VA Office of Research and Development at 17 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
High dose testosterone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
17 sitesUnited States
Study dates
31 Aug 2021to 31 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Robert B Montgomery, MD contact

(206) 277-6878

Robert.Montgomery@va.gov

Elahe Mostaghel, MD contact

(206) 762-1010

emostagh@fhcrc.org

17 sites in 1 country

United States17 sites, 17 recruiting

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045

    Daniel Bowles, MD, 720-723-6498, Daniel.Bowles@va.gov

    Recruiting

  • Ralph H. Johnson VA Medical Center, Charleston, SC

    Charleston, South Carolina, 29401-5799

    Steven Savage, MD, 843-792-4531, Stephen.Savage@va.gov

    Recruiting

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033

    Maria Ribeiro, MD, 404-728-7680, Maria.Ribeiro@va.gov

    Recruiting

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705

    Rhonda Bitting, MD, 919-286-0411 ext. 17-5441, Rhonda.Bitting@va.gov

    Recruiting

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida, 32608

    Jess D Delaune, MD, 352-988-7504, Jess.Delaune@va.gov

    Recruiting

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030

    Anita Sabichi, MD, 713-798-3750, Anita.Sabichi@va.gov

    Not yet recruiting

  • Kansas City VA Medical Center, Kansas City, MO

    Kansas City, Missouri, 64128

    Linda Verkruyse, MD, 817-681-7115, Linda.Verkruyse@va.gov

    Recruiting

  • Robley Rex VA Medical Center, Louisville, KY

    Louisville, Kentucky, 40206-1433

    Fred Hendler, MD, 502-287-3515

    Recruiting

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

    Madison, Wisconsin, 53705-2254

    David Kosoff, MD, 608-256-1901, David.Kosoff@va.gov

    Recruiting

  • Memphis VA Medical Center, Memphis, TN

    Memphis, Tennessee, 38104-2127

    Alva Weir, MD, 901-523-8990 ext. 6853

    Recruiting

  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

    Nashville, Tennessee, 37212-2637

    Sally York, MD, 615-873-6979

    Recruiting

  • Orlando VA Medical Center, Orlando, FL

    Orlando, Florida, 32803

    Priya K Gopalan, MD, 407-631-2389, Priya.Gopalan@va.gov

    Recruiting

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97239

    Julie Graff, MD, 503-220-8262, Julie.Graff@va.gov

    Recruiting

  • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

    Salisbury, North Carolina, 28144

    Michael Goodman, MD, 704-638-9000 ext. 15038

    Recruiting

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108-1532

    Robert B Montgomery, MD, (206) 277-6878, Robert.Montgomery@va.gov

    Robert B. Montgomery, MD

    Recruiting

  • St. Louis VA Medical Center John Cochran Division, St. Louis, MO

    St Louis, Missouri, 63106

    Eric Knoche, MD, 314-289-6305, Eric.Knoche@va.gov

    Recruiting

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    West Haven, Connecticut, 06516-2770

    Herta Chao, MD, 203-937-3421, Herta.Chao@va.gov

    Recruiting

Other trials in United States

About this study

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

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

Read the detailed description

This is an unblinded, three cohort phase II study evaluating the efficacy of high dose testosterone (BAT) for patients with mCRPC and inactivating mutations in ATM, CDK12 or CHEK2. Patients will receive BAT until disease progression or intolerance, whichever occurs first. Throughout the study, safety and tolerability will be assessed by frequent recording of adverse events, vital signs and safety laboratory assessments. Progression will be evaluated with bone scan, CT of the abdomen/pelvis and PSA as per PCWG3 criteria.

Being tested
High dose testosterone
Keywords
Prostatic Neoplasms
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High dose testosteroneDrug

    Also called Bipolar androgen therapy

    High dose testosterone is administered subcutaneously once monthly until progression or toxicity

Study groups in NCT05011383
Study groupRoleWhat they receive
ATMExperimentalPatients with castration resistant prostate cancer which contains ATM alterations are treated with high dose testosterone
Receives: Drug: High dose testosterone
CDK12ExperimentalPatients with castration resistant prostate cancer which contains CDK12 alterations are treated with high dose testosterone
Receives: Drug: High dose testosterone
CHEK2ExperimentalPatients with castration resistant prostate cancer which contains CHEK2 alterations are treated with high dose testosterone
Receives: Drug: High dose testosterone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PSA response

    PSA response as measured by a 50% decline from baseline maintained for 12 weeks

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start31 Aug 2021
  3. Primary completion3 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
3 cohort phase II study
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05011383
Sponsor's protocol ID
SPLP-003-20F
Acronym
VA-BAT
Status last verified
Sep 2026
First submitted
11 Aug 2021
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing High dose testosterone in people with Metastatic Prostate Cancer, run by VA Office of Research and Development at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Robert B Montgomery, MD ((206) 277-6878, Robert.Montgomery@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PSA response (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05011383.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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