Metastatic Castration-resistant Prostate CancerPhase 2NCT07476001
Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC
A Phase 2 study testing Testosterone cypionate (Tc), ADT with Luteinizing hormone-releasing hormone (LHRH) analog and PSMA-617 in people with Metastatic Castration-resistant Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Testosterone cypionate (Tc), ADT with Luteinizing hormone-releasing hormone (LHRH) analog and PSMA-617
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2026to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Jingsong Zhang, MD, PhD
Juskaran Chadha, DO
About this study
Official title: 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.
- Being tested
- Testosterone cypionate (Tc), ADT with Luteinizing hormone-releasing hormone (LHRH) analog, PSMA-617
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone cypionate (Tc)Drug
IM injection of Tc at 400 mg (Tc400) every 28 days for up to 3 doses.
ADT with Luteinizing hormone-releasing hormone (LHRH) analogDrug
Continuing ADT with either surgical castration or chemical castration with LHRH analog is considered standard of care for mCRPC.
PSMA-617Drug
IV at 7.4GBq (200mCi) once every 6 weeks for up to 6 doses.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Tc400 followed by PSMA-617 (with continued ADT) | Experimental | Participants will receive Tc400 followed by PSMA-617, while continuing standard of care androgen deprivation therapy. Receives: Drug: Testosterone cypionate (Tc); Drug: ADT with Luteinizing hormone-releasing hormone (LHRH) analog; Drug: PSMA-617 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Tc400 and PSMA-617
Percentage of patients who can complete 3 doses of Tc400 followed by at least 2 doses of PSMA-617.
Measured: Up To 6 Months
Secondary outcomes (2)
Reduction in P/T ratio
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.
Measured: Up To 6 Months
PSA50 and PSA 90
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.
Measured: Up To 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start3 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingsong Zhang, MD, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476001
- Sponsor's protocol ID
- MCC-23775
- Status last verified
- May 2026
- First submitted
- 12 Mar 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study of High Dose Testosterone Followed by Targeted Radioligand Therapy in Metastatic Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT07476001
- Acronym / sponsor ID
- MCC-23775
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Tc400 followed by PSMA-617 (with continued ADT) | Experimental | Drug: Testosterone cypionate (Tc), Drug: ADT with Luteinizing hormone-releasing hormone (LHRH) analog, Drug: PSMA-617Participants will receive Tc400 followed by PSMA-617, while continuing standard of care androgen deprivation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone cypionate (Tc)IM injection of Tc at 400 mg (Tc400) every 28 days for up to 3 doses. | Drug | Single Arm: Tc400 followed by PSMA-617 (with continued ADT) |
| ADT with Luteinizing hormone-releasing hormone (LHRH) analogContinuing ADT with either surgical castration or chemical castration with LHRH analog is considered standard of care for mCRPC. | Drug | Single Arm: Tc400 followed by PSMA-617 (with continued ADT) |
| PSMA-617IV at 7.4GBq (200mCi) once every 6 weeks for up to 6 doses. | Drug | Single Arm: Tc400 followed by PSMA-617 (with continued ADT) |
Primary outcome
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.
2 secondary outcomes
Reduction in P/T ratio
Time frame: Up To 6 Months
PSA50 and PSA 90
Time frame: Up To 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jingsong Zhang, MD, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone cypionate (Tc), ADT with Luteinizing hormone-releasing hormone (LHRH) analog and PSMA-617 in people with Metastatic Castration-resistant Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Smith (813-745-2937, Ashley.Smith@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Tc400 and PSMA-617 (time frame: Up To 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.