Alpha-emitting therapy for advanced 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 clinical trial evaluates the safety and tolerability of a new radiopharmaceutical, 225Ac-PSMA I&T, for treating metastatic castration-resistant prostate cancer. The study involves a single-center, single-arm, phase I dose escalation design, where up to 30 patients will receive therapy with varying doses of the radionuclide. Patients will undergo PET-MRI scans to assess the effects of the treatment on cancer metastases and to determine the appropriate dosage for future studies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histopathological proven metastatic castration resistant prostate cancer. Castrationresistant disease is defined as a serum testosterone level of 50 nanogram per deciliter or lower (≤1.7 nanomol per liter) after bilateral orchiectomy or during maintenance treatment consisting of androgen-ablation therapy with a luteinizing hormone-releasing hormone agonist.
* Evidence of progressive disease, defined as 1 or more Prostate Cancer Work Grouping 3 (PCWG3) criteria: - PSA level ≥ 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart
* Progression as defined by RECIST 1.1 with PCGW3 modifications
* Progression after at least one line of chemotherapy and/or one line of nonsteroidal antiandrogen (NSAA).
* No active anti-tumor therapy, except for androgen deprivation therapy in combination with at least one androgen receptor-targeted agent
* Willing and able to undergo 2 cycles of 225Ac-PSMA I\&T therapy and 3 PET-MRI scans in 16 weeks and comply with protocol
* Signed and dated written informed consent by the patient (or legal representative) prior to any study-specific procedures.
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance-status score 0-2.
* Use of highly effective methods of contraception (female partners of male participants)
* During the trial and 6 months after completion of the study or willing to practice sexual abstinence.

Exclusion Criteria:

* Concurrent severe illness or clinically relevant trauma within 2 weeks before the administration of the investigational product that might preclude study completion or interfere with study results
* Serum hemoglobin ≤ 6.2 mmol/L, total white blood cell (WBC) count ≤ 3.5·109/L, absolute neutrophil count ≤ 1.5·109/L, platelet count ≤ 100·109/L, serum creatinine concentration ≥ 150 umol/L (≥ 1.7 mg/dL), serum albumin \<30 g/L, bilirubin ≥ 1.5 x upper limit normal (ULN), aspartate transaminase (ASAT) ≥ 3 x ULN and alanine aminotransferase (ALAT) ≥ 3 x ULN (or bilirubin ≥ 3 x ULN, ASAT ≥ 5 x ULN and ALAT ≥ 5 x ULN in the case of pre-existing liver metastases at baseline)
* Concurrent bladder outflow obstruction or unmanageable urinary incontinence
* Known or expected hypersensitivity to Gallium-68, Actinium-225, PSMA I\&T, or any excipient present in 225Ac/68Ga-PSMA I\&T
* Prior administration of a radiopharmaceutical within a period corresponding to 8 halflives of the radionuclide used on such radiopharmaceutical
* Prior treatment with any radionuclide therapy
* History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
* Central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
* Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose)
* Male subjects unwilling to abstain from donating sperm during treatment and for an additional 6 months after the last dose

Where it's running

• Erasmus Medical Center
  Rotterdam, Zuid-Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Sui wai Ling
• Email: s.ling@erasmusmc.nl
• Phone: +31107033612

Similar studies

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

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

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• Fractionated Stereotactic Radiotherapy Plus Second-Generation Antiandrogen in oligometastatic castration-resistant prostate cancer

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• Pluvicto real-world use in metastatic castration-resistant prostate cancer

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• Real-world patterns and outcomes for mCRPC patients who have had ARPI, taxane, and 177Lu-PSMA-617

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  Recruiting Novartis · East Hanover, New Jersey · NCT07677267

• Real-world patterns and outcomes in metastatic castration-resistant prostate cancer

  This study tests how patients with metastatic castration-resistant prostate cancer are treated and how they fare in real-world U.S. practice using the PRECISION data platform.

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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.