- 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
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.
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
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
Publications
N/A
Websites
N/A
NCT05902247
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