Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

This study is testing if giving high-dose testosterone cypionate before a targeted radioligand therapy (PSMA-617) can help men with metastatic castration-resistant prostate cancer (mCRPC). mCRPC is prostate cancer that has spread and is no longer responding to standard hormone therapy. You would continue your current hormone therapy (ADT with LHRH analog). To join, you must have mCRPC that has gotten worse based on PSA levels or imaging, and no severe cancer-related symptoms. The main goal is to see if this treatment approach is possible and safe. This study plans to enroll 12 participants, but its current recruitment status is unclear.

Study design: This is an interventional study, meaning participants will receive specific treatments. It is a Phase 2a study, and it plans to enroll 12 participants.
What's involved: Participants will spend about 6 months in this study and will take study drugs for 3.5 months. This involves receiving testosterone cypionate injections and PSMA-617 intravenously.
Compensation: Not stated in the trial record.
Follow-up: The feasibility of the treatments will be measured for up to 6 months.

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Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

Recruiting

PHASE2Ages 18+InterventionalTreatment

H. Lee Moffitt Cancer Center and Research Institute

~12 participants

Updated 2026-05-15 on ClinicalTrials.gov

What's tested:Testosterone cypionate (Tc)ADT with Luteinizing hormone-releasing hormone (LHRH) analogPSMA-617

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Feasibility of Tc400 and PSMA-617

Measured over Up To 6 Months

Conditions

Metastatic Castration-resistant Prostate Cancer

Where it's being run

1 sites across 1 states

Florida1

Study leadership

Jingsong Zhang, MD, PhD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Ashley Smith

[email protected]

813-745-2937

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must have histologically or cytologically confirmed prostate cancer that has progressed to mCRPC with no grade 2 or above cancer related symptoms.

Participants need to have either PSA or imaging progression at castrate level of serum testosterone (i.e. \<50ng/dl). The definition of PSA progression and the definitions of imaging progression on measurable or non-measurable lesions will be based on the prostate cancer working group 3 (PCWG3) criteria. Patients with symptomatic oligo progression (1-3 sites), the symptoms need to be improved to grade 1 or less with palliative local therapy prior to study enrollment.

Participants need to have a positive PSMA PET scan and deem eligible for PSMA-617.

Allowable prior therapies: Prior treatment with one line of ARPI. Patients need to be on ARPI for at least 4 weeks to be considered one line of therapy. Prior treatment with sipuleucel-T for mCRPC. Prior treatment with docetaxel in the castration sensitive setting.

ECOG performance status 0-1.

Participants must have adequate organ and marrow functions.

Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Participants with h/o myocardial infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment.

Non-sterilized men who are sexually active with a female partner of childbearing potential treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 weeks after last dose of enzalutamide or docetaxel administration.

Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the subject's behalf. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion

Metastatic prostate cancer with known epidural, liver or brain metastases.

No history of cord compression.

Treatment with radiation within 30 days prior to the first dose of Tc400.

Receiving any other investigation agents. Prior treatment with investigation agents need to have a washout period of 4 weeks prior to enrollment.

Participants with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, delayed healing of wounds, ulcers, or bone fractures, or psychiatric illness/social situations that would limit compliance with study requirements.

What this trial measures

Feasibility of Tc400 and PSMA-617Up To 6 Months
Percentage of patients who can complete 3 doses of Tc400 followed by at least 2 doses of PSMA-617.

Trialytics