Hormone boost then radiation: new hope for tough prostate cancer?
NCT ID NCT07476001
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new two-step approach for men with advanced prostate cancer that has stopped responding to standard hormone therapy. First, patients receive a high dose of testosterone, followed by a targeted radioactive drug. The goal is to see if this combination is safe and can shrink the cancer. About 12 men will take part for roughly 6 months.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Training a Patient's own immune cells to fight advanced prostate cancer
- Radioactive missile aims at prostate cancer that spread
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer
- Can a Hormone-Blocking drug boost chemotherapy against prostate cancer?
- Can a Cancer-Targeting drug slow advanced prostate cancer?