High-dose testosterone followed by PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2a interventional trial gives participants high-dose testosterone (testosterone cypionate) for about 3.5 months while keeping them on androgen-deprivation therapy, followed by PSMA-617 targeted radioligand therapy for PSMA-positive tumors. Eligible participants must have mCRPC with biochemical or imaging progression at castrate serum testosterone and a positive PSMA PET scan. The protocol allows prior one line of androgen receptor pathway inhibitor and certain prior chemo or sipuleucel-T as specified. Participants are followed for roughly six months to measure tumor response, safety, and treatment tolerability.

Why it matters

Who can join: the full rules

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.

Where it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Jingsong Zhang, MD, PhD — Moffitt Cancer Center
• Study coordinator: Ashley Smith
• Email: Ashley.Smith@moffitt.org
• Phone: 813-745-2937

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• JUR-003 in adults with advanced prostate cancer

  This first-in-human study tests JUR-003 to see if it is safe and tolerable and to get an early sense of activity in adults with metastatic or advanced prostate cancer.

  Recruiting at 4 sites Phase 1 TCG Labs Soleil · Grand Rapids, Michigan and 3 other locations · NCT07824349

• SRT-017 radioligand therapy in PSMA-positive metastatic castration-resistant prostate cancer

  This study tests SRT-017 given by IV infusion to men with PSMA-positive metastatic castration-resistant prostate cancer to see if it is safe and tolerable and to gather early signals of anti-tumor activity.

  Recruiting Early Phase 1 Affiliated Hospital of Jiangnan University · Wuxi, Jiangsu · NCT07798778

• Rinzimetostat plus darolutamide in metastatic castration-resistant prostate cancer after abiraterone failure

  This study tests whether adding rinzimetostat to darolutamide helps people with metastatic castration-resistant prostate cancer who previously took abiraterone.

  Recruiting at 15 sites Phase 3 ORIC Pharmaceuticals · Glendale, California and 14 other locations · NCT07723248

• FX-111 safety and pharmacokinetics in metastatic castration-resistant prostate cancer

  This study tests whether FX-111 is safe and can help treat metastatic castration-resistant prostate cancer in adult men.

  Recruiting at 7 sites Phase 1 Flare Therapeutics Inc. · Los Angeles, California and 9 other locations · NCT07719361

• Docetaxel and SX-682 in head and neck cancers and prostate cancer

  This trial tests a new drug SX-682 together with docetaxel in adults whose head and neck cancers or prostate cancer have returned or spread.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07667400

• Dual-target PSMA/PSCA CAR-NK Therapy in Advanced Prostate Cancer

  This trial tests ETB-DualNK-01, a dual-target CAR-NK cell therapy, in adults with metastatic castration-resistant prostate cancer to see if it is safe and shows early signs of activity.

  Recruiting Phase 1 Beijing Biotech · Shenzhen, Guangdong · NCT07641049

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.