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

May 14, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

A Phase 2a Study of High Dose Testosterone Followed by Targeted Radioligand Therapy in Metastatic Castration Resistant Prostate Cancer

The purpose of this study is to evaluate whether high-dose testosterone followed by targeted radioligand therapy (TRT) is effective in treating metastatic castration resistant prostate cancer. Participants will be asked to spend about 6 months in this study. Participants will take study drug for 3.5 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Sub-Investigator:
          • Juskaran Chadha, DO
        • Principal Investigator:
          • Jingsong Zhang, MD, PhD
        • Sub-Investigator:
          • Aakash Patel, MD
        • Sub-Investigator:
          • Jon Chatzkel, MD
        • Sub-Investigator:
          • Ghazal (Gigi) Jameel, APRN
        • Sub-Investigator:
          • Angel Johnson, APRN
        • Sub-Investigator:
          • Tianshi (Mike) Liu, MD
        • Sub-Investigator:
          • Sarah Mizelle, PA-C
        • Sub-Investigator:
          • Aditi Patel, PA-C
        • Sub-Investigator:
          • Alyssa Thompson, APRN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single Arm: Tc400 followed by PSMA-617 (with continued ADT)
Participants will receive Tc400 followed by PSMA-617, while continuing standard of care androgen deprivation therapy.
Drug: Testosterone cypionate (Tc)
IM injection of Tc at 400 mg (Tc400) every 28 days for up to 3 doses.
Drug: ADT with Luteinizing hormone-releasing hormone (LHRH) analog
Continuing ADT with either surgical castration or chemical castration with LHRH analog is considered standard of care for mCRPC.
Drug: PSMA-617
IV at 7.4GBq (200mCi) once every 6 weeks for up to 6 doses.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of Tc400 and PSMA-617
Time Frame: Up To 6 Months
Percentage of patients who can complete 3 doses of Tc400 followed by at least 2 doses of PSMA-617.
Up To 6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reduction in P/T ratio
Time Frame: Up To 6 Months
Percentage of evaluable patients with 50% reduction in P/T ratio (PT50) compared to baseline P/T ratio based on PSA and testosterone values at screening.
Up To 6 Months
PSA50 and PSA 90
Time Frame: Up To 6 Months
Percentage of patients who achieved PSA50 and PSA 90 responses after two doses of PSMA-617 compared to the pre PSMA-617 PSA values at day 60.
Up To 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lee Moffitt Cancer Center and Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jingsong Zhang, MD, PhD, Moffitt Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MCC-23775

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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