Actium-225-Prostate Specific Membrane Antigen Imaging & Therapy

  • Recruiting
  • Treatment
  • Interventional
  • Radiation
  • PHASE1
  • Erasmus Medical Center
  • 18 Years -


Study Purpose

225Ac-PSMA I\&T is a radiopharmaceutical for therapy of prostate cancer. PSMA is overexpressed on prostate cancer cells. Actium-225 is an alpha emitting radionuclide. When PSMA I\&T is labelled with Actium-225, it can be applied as therapy for prostate cancer.

Intervention

Radiation : Radionuclide Therapy


Eligibility Requirements

info icon 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.

info icon 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

info icon Progression as defined by RECIST 1.1 with PCGW3 modifications

info icon Progression after at least one line of chemotherapy and/or one line of nonsteroidal antiandrogen (NSAA).

info icon No active anti-tumor therapy, except for androgen deprivation therapy in combination with at least one androgen receptor-targeted agent

info icon 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

info icon Signed and dated written informed consent by the patient (or legal representative) prior to any study-specific procedures.

info icon Age ≥ 18 years.

info icon Eastern Cooperative Oncology Group (ECOG) performance-status score 0-2.

info icon Use of highly effective methods of contraception (female partners of male participants)

info icon During the trial and 6 months after completion of the study or willing to practice sexual abstinence.

info icon 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

info icon 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)

info icon Concurrent bladder outflow obstruction or unmanageable urinary incontinence

info icon Known or expected hypersensitivity to Gallium-68, Actinium-225, PSMA I\&T, or any excipient present in 225Ac/68Ga-PSMA I\&T

info icon Prior administration of a radiopharmaceutical within a period corresponding to 8 halflives of the radionuclide used on such radiopharmaceutical

info icon Prior treatment with any radionuclide therapy

info icon History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study

info icon Central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression

info icon Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose)

info icon Male subjects unwilling to abstain from donating sperm during treatment and for an additional 6 months after the last dose

Recruiting status

Recruiting

Estimated enrollment

30

 
Study start date

Dec 29, 2021

Study end date

Dec 29, 2025

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Radiation

Study phase

PHASE1

Allocation

Na

 

Sponsor:

Erasmus Medical Center

Collaborator:

Dutch Cancer Society

Investigator:

N/A

NCT05902247

Clinic Location Investigator Distance RECRUITING STATUS Contact