Testing [225Ac]Ac-PSMA-XT, a PSMA-targeted alpha therapy, in men with 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 is a Phase 1 interventional study that gives an Actinium‑225 labeled PSMA ligand ([225Ac]Ac-PSMA-XT) to men with PSMA PET–positive metastatic castration‑resistant prostate cancer to determine safety, tolerability, and preliminary signs of benefit. Participants must have prior androgen-axis therapy and prior taxane chemotherapy or be unsuitable for taxanes, an ECOG performance status of 0–1, and adequate organ function. The study will monitor adverse events, laboratory measures, and early efficacy signals such as imaging and clinical progression. Treatment is administered at a single center and patients are followed for safety and response outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. have the ability to understand and sign an approved informed consent form (ICF).
2. \>= 18 years old.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. have a life expectancy \>6 months.
5. have histological, pathological, and/or cytological confirmation of prostate cancer.
6. PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive
7. have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).
8. have received at least one NAAD (such as enzalutamide and/or abiraterone)； patients must have been previously treated undergone at least 1-2 prior taxane-based chemotherapy regimens or be unsuitable for taxane therapy (unsuitability includes contraindications, investigator-determined ineligibility, or patient refusal) in mCRPC stage.
9. progressive mCRPC.
10. have adequate organ function。
11. Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, Intra-uterine device（IUD）,etc., during treatment and within 6 months of the last use of the trial drug.

Exclusion Criteria:

1. Previous treatment with any of the following within 6 months of enrollment: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.

   Known other malignancies.
2. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy within 28 days prior to day of enrollment.
3. Known hypersensitivity to the components of the study therapy or its analogs.
4. A superscan as seen in the baseline bone scan.
5. Patients with a history of Central Nervous System (CNS) metastases.
6. Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, cardiac arrhythmia, or other severe complications.

Where it's running

• Cancer Hospital of Shandong First Medical University
  Jinan, Shandong, China Recruiting

Similar studies

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

• JANX013 and JANX007 combo in advanced prostate cancer

  A first-in-human study will test JANX013 together with JANX007 to see if this combination is safe and tolerable in adults with metastatic castration-resistant prostate cancer.

  Recruiting Phase 1 Janux Therapeutics · Nashville, Tennessee · NCT07813637

• TSL2109 capsules for advanced solid tumors, including treatment‑resistant prostate cancer

  This trial tests whether the oral drug TSL2109 is safe, tolerable, and shows early signs of benefit for people with advanced solid tumors, especially those with metastatic castration‑resistant prostate cancer who have progressed after standard therapies.

  Recruiting Phase 1 Tasly Pharmaceutical Group Co., Ltd · Shanghai, Shanghai Municipality · NCT07514065

• KTX-2001 (alone and with darolutamide) for men with metastatic castration‑resistant prostate cancer

  This trial tests whether KTX-2001, by itself and combined with darolutamide, can help men whose prostate cancer has spread and stopped responding to hormone therapies.

  Recruiting at 13 sites Phase 1 K36 Therapeutics, Inc. · San Francisco, California and 12 other locations · NCT07103018

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.