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Can a blast of testosterone shrink hard-to-treat prostate cancer?

NCT ID NCT05011383

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial investigates whether high doses of testosterone can shrink tumors in men with metastatic prostate cancer that no longer responds to standard hormone therapy and has mutations in DNA repair genes like ATM or CDK12. Participants receive monthly injections of high-dose testosterone while continuing standard hormone suppression. The study aims to see if this approach triggers a significant drop in PSA levels, a marker of cancer activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
high-dose testosterone (bipolar androgen therapy)
What this could lead to
If it works, this could offer a new treatment option for men with metastatic prostate cancer that has stopped responding to standard hormone therapy and carries certain gene mutations.
What could go wrong
This is a small, early-phase trial, so results may not apply broadly. High-dose testosterone can cause side effects like worsening cancer growth, heart problems, or mood changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 51 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    RECRUITING

    Decatur, Georgia, 30033, United States

  • Durham VA Medical Center, Durham, NC

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Kansas City VA Medical Center, Kansas City, MO

    RECRUITING

    Kansas City, Missouri, 64128, United States

  • Memphis VA Medical Center, Memphis, TN

    RECRUITING

    Memphis, Tennessee, 38104-2127, United States

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

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

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

    RECRUITING

    Gainesville, Florida, 32608, United States

  • Orlando VA Medical Center, Orlando, FL

    RECRUITING

    Orlando, Florida, 32803, United States

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

    RECRUITING

    Charleston, South Carolina, 29401-5799, United States

  • Robley Rex VA Medical Center, Louisville, KY

    RECRUITING

    Louisville, Kentucky, 40206-1433, United States

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    RECRUITING

    Aurora, Colorado, 80045, United States

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

    RECRUITING

    Salisbury, North Carolina, 28144, United States

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

    RECRUITING

    St Louis, Missouri, 63106, United States

  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

    RECRUITING

    Nashville, Tennessee, 37212-2637, United States

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

    RECRUITING

    West Haven, Connecticut, 06516-2770, United States

  • VA Portland Health Care System, Portland, OR

    RECRUITING

    Portland, Oregon, 97239, United States

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

    RECRUITING

    Seattle, Washington, 98108-1532, United States

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

    RECRUITING

    Madison, Wisconsin, 53705-2254, United States

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