Supraphysiologic Testosterone Priming for Metastatic Prostate Cancer
This study is testing a new approach for men with metastatic castration-resistant prostate cancer (prostate cancer that has spread and no longer responds to standard hormone therapy). It combines high-dose testosterone cypionate with darolutamide, a hormone therapy drug, and an LHRH analogue (another type of hormone therapy). The goal is to see if this alternating treatment can prevent the cancer from becoming resistant to hormone therapy, reduce side effects, and improve quality of life. You may be eligible if you are a man aged 18 or older with confirmed prostate cancer that has spread, and have not had prior hormone therapy for recurrent or metastatic disease. The study will measure how many participants are free from cancer progression after 24 months. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 60 male participants. It is not specified if it is randomized or blinded.
- What's involved
- Eligible patients will receive intermittent intramuscular testosterone cypionate every 4 weeks, along with an LHRH analogue and darolutamide (600 mg twice daily) for a total of 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for clinical or radiographic progression for 24 months from the start of treatment.
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NCT07142551
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
Recruiting
PHASE2Ages 18+InterventionalTreatmentSidney Kimmel Comprehensive Cancer Center at Johns HopkinsInvestigator-initiated
~60 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:Testosterone cypionateLuteinizing hormone-releasing hormone (LHRH) analogueDarolutamide
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of subjects free of Clinical or radiographic free progression
Measured over 24 months from Day 1 (start of treatment)
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Samuel Denmeade, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age ≥ 18 years
Performance status ≤2.
Documented histologically confirmed adenocarcinoma of the prostate.
Baseline PSA ≥1.0 ng/ml.
No prior androgen deprivation therapy (i.e. surgical castration LHRH agonist, LHRH antagonist) as treatment for biochemically recurrent or metastatic disease (may have received neoadjuvant, concurrent and/or adjuvant AD therapy in the context of definitive radiation therapy if it was administered ≥ 1 year prior to recurrence).
No prior treatment with ARPI (abiraterone, enzalutamide, darolutamide) for biochemically recurrent or metastatic prostate cancer. Neoadjuvant, concurrent and/or adjuvant ARPI +/- ADT is permitted if given in the context of definitive radiation therapy if it was administered ≥ 1 year prior to development of metastatic disease.
Prior focal radiation treatment (e.g. SABR, Cyberknife) for oligometastatic disease is permitted if \> 6 months. Patients must have evidence of metastatic disease in non-irradiated sites to be eligible for study.
Evidence of rising PSA on two successive dates \> 2 weeks apart.
Evidence of metastatic disease on CT scan or bone scan performed with six weeks of screening.
Patients with bone pain due to prostate cancer are eligible for trial but must be pain free at the end of the 6-month lead-in phase to be eligible to receive subsequent BAT.
Patients with soft tissue lesions amenable to biopsy must agree to baseline and 6 months tumor biopsies to enroll in study.
Acceptable liver function:
Acceptable renal function:
Acceptable hematologic status:
Ability to understand and willingness to sign a written informed consent document.
Exclusion
No prior treatment with chemotherapeutic regimens allowed.
No prior treatment with Pluvicto or other PSMA-targeted agents is allowed.
No prior treatment with Androgen Receptor targeted investigational agents is permitted.
Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
Evidence of disease that, in the opinion of the investigator, would put the patient at risk from testosterone therapy (e.g. femoral metastases with concern over fracture risk, spinal metastases with concern over spinal cord compression, lymph node disease with concern for ureteral obstruction).
Requires urinary self-catheterization for voiding due to obstruction secondary to prostatic enlargement well-documented to be due to prostate cancer or benign prostatic hyperplasia (BPH). Patients with indwelling Foley or suprapubic catheter for obstructive symptoms are eligible.
Active uncontrolled infection.
Any condition or mental impairment that may compromise the ability to give informed consent, patient's safety or compliance with study requirements as determined by the investigator.
Patients receiving anticoagulation therapy with Warfarin or Coumadin are not eligible for study. Patients on non-coumadin anticoagulants (Lovenox, Eliqis, Xarelto, etc.) are eligible for study. Patients on Coumadin who can be transitioned to non-coumadin anticoagulants prior to starting study treatments will be eligible.
Hematocrit \>51%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure \[per Endocrine Society Clinical Practice Guidelines (34)\]
Patients allergic to sesame seed oil or cottonseed oil are excluded.
Major surgery as determined by the treating physician within 3 weeks before screening, or has not fully recovered from prior surgery (i.e., unhealed wound). Note: subjects with planned procedures (minor surgery with local anesthesia), colonoscopy under anesthesia may participate.
Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within the last five years prior to enrollment in the study.
Inability to provide informed consent.
What this trial measures
- Percent of subjects free of Clinical or radiographic free progression24 months from Day 1 (start of treatment)
Percent of subjects are free of clinical or radiographic progression at 24 months from initiation of treatment