Actium-225-Prostate Specific Membrane Antigen Imaging & Therapy

NCT05902247 | Unknown Phase 1

• 1 other identifier: NL73234.078.20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostatic Neoplasms, Castration-Resistant

Keywords

225Ac-PSMA; Prostate cancer

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of Adverse Events and Serious Adverse Events as assessed by CTCAE v5.0

  Safety and tolerability assessment

  4 years

• Absolute values and changes from baseline in laboratory parameters (hematology, blood chemistry and urinalysis), including assessment of shifts from baseline to abnormal values on treatment

  Safety and tolerability assessment

  4 years

• Absolute values and changes from baseline in vital signs & ECG parameters

  Safety and tolerability assessment

  4 years

Secondary Outcomes (8)

• To predict and calculate the absorbed-dose in critical organs (e.g. salivary glands, kidneys, bone marrow) by 68Ga-PSMA I&T PET-MRI

  4 years

• Changes in SUVmax of the target lesions on PET-MRI and morphological changes evaluated on MRI

  4 years

• Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v.1.1.

  4 years

• Percent changes from baseline in tumor size where tumor size is defined as the sum of all target lesions as measured by RECIST criteria v.1.1.

  4 years

• Prostate Specific Antigen(PSA) response rate assessed from treatment visit 1 defined as a decrease in PSA of ≥ 50% from baseline.

  4 years

Study Arms (1)

225Ac-PSMA I&T

EXPERIMENTAL

225Ac-PSMA I\&T

Radiation: Radionuclide Therapy

Interventions

Radionuclide Therapy RADIATION

To evaluate the tolerability and safety of 225Ac-PSMA I\&T in patients with metastatic prostate cancer

Also known as: 225Ac-PSMA I&T

225Ac-PSMA I&T

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Dutch Cancer Society: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Related Publications (1)

• Ling SW, van der Veldt AAM, Konijnenberg M, Segbers M, Hooijman E, Bruchertseifer F, Morgenstern A, de Blois E, Brabander T. Evaluation of the tolerability and safety of [225Ac]Ac-PSMA-I&T in patients with metastatic prostate cancer: a phase I dose escalation study. BMC Cancer. 2024 Jan 29;24(1):146. doi: 10.1186/s12885-024-11900-y.

  PMID: 38287346 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Sui wai Ling

CONTACT

+31107033612; s.ling@erasmusmc.nl

Laurens Groenendijk

CONTACT

+31107033612; imaging.trialbureau@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A clinical prospective, single-center, single-arm, phase I dose escalation therapy study.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 13, 2023
• Study Start: December 29, 2021
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)