Actium-225-Prostate Specific Membrane Antigen Imaging & Therapy

Launched by ERASMUS MEDICAL CENTER · Jun 5, 2023

Keywords

ClinConnect Summary

The Actium-225 trial is studying a new treatment for men with advanced prostate cancer that has not responded to standard hormone therapies. This treatment uses a special drug called 225Ac-PSMA I&T, which targets prostate cancer cells specifically. The goal is to see if this drug can help slow down or stop the cancer from progressing. To be eligible, participants need to have a confirmed diagnosis of metastatic castration-resistant prostate cancer and evidence that their cancer is getting worse despite previous treatments. They should also be willing to undergo two treatment cycles and several imaging tests over about 16 weeks.

Participants in this trial can expect to receive the targeted therapy and will be closely monitored with imaging scans to track how their cancer responds. It’s essential that they meet certain health criteria, such as being in relatively good overall health and not having severe health issues that could interfere with the study. The trial is currently recruiting men aged 18 and older, and participants will need to provide informed consent and follow specific guidelines, including abstaining from donating sperm during the study and for six months afterward. This trial represents a hopeful new approach in the fight against prostate cancer.

Gender

MALE

Eligibility criteria

• 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