Phase I dose escalation study to evaluate tolerability and safety of 225Ac-PSMA in patients with metastatic prostate cancer

Phase I dose escalation study to evaluate tolerability and safety of 225Ac-PSMA in patients with metastatic prostate cancer - Phase I study of 225Ac-PSMA in prostate cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52446

Enrollment

Registered

2021-02-09

Start date

2022-03-22

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

Ac-PSMA

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Histopathological proven metastatic castration resistant prostate cancer - Progression after at least one line of chemotherapy and one line of nonsteroidal antiandrogen

Exclusion criteria

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 = 150 umol/L (>= 1.7 mg/dL), serum albumin

Design outcomes

Primary

Measure	Time frame
Primary study endpoints · Safety and tolerability of 225Ac-PSMA in patients with mCRPC as assessed by: o Incidence and severity of adverse events and serious adverse events o 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 o Absolute values and changes from baseline in vital signs & ECG parameters	—

Measure

Time frame

Primary study endpoints · Safety and tolerability of 225Ac-PSMA in patients with mCRPC as assessed by: o Incidence and severity of adverse events and serious adverse events o 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 o Absolute values and changes from baseline in vital signs & ECG parameters

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Secondary

Measure	Time frame
Secondary study endpoints · The following 68Ga-PSMA distribution and radiation dosimetry endpoints will be calculated: o Volume calculations of critical organs and tumor by PET-MRI. o Expected radiotracer uptake calculated as a percentage of the injected dose per gram of tissue (%ID/g) o Expected absorbed doses and effective whole body dose of 225Ac-PSMA · Direct effect of 225Ac-PSMA will be monitored by: o Changes in SUVmax of the target lesions on PET-MRI o Changes in perfusion measured on MRI · The preliminary action of the therapeutic doses of 225Ac-PSMA will be assessed according to the last PET-MRI. These imaging techniques will be used to derive the following endpoints where relevant: o Objective response rate (ORR) as measured by RECIST criteria v.1.1. This is defined as the number of patients with either a complete response (CR) or partial response (PR) at any time point which is confirmed a minimum of 4 weeks later, divided by the total number of patients with visceral disease at baseline. o Percent changes from baseline in tumor size where tumor size is defined as the sum of all target lesions as measured by RECIST 1.1. Only patients with measurable disease at baseline (i.e. target lesions identified and measured) will contribute to these analyses. o PSA response rate assessed from treatment visit 1 defined as a decrease in PSA of >= 50% from baseline. o Percent change from baseline in PSA as a continuous endpoint by visit and maximum reduction during the study o Percent change from baseline values of pain questionnaire at every treatment visit o Overall Survival defined as the time from the date of first dose of 225Ac-PSMA treatment to the date of death due to any cause. Any subject not known to have died at the time of the analysis will be censored based on the last recorded date on which the subject was known to be alive.	—

Measure

Time frame

Secondary study endpoints · The following 68Ga-PSMA distribution and radiation dosimetry endpoints will be calculated: o Volume calculations of critical organs and tumor by PET-MRI. o Expected radiotracer uptake calculated as a percentage of the injected dose per gram of tissue (%ID/g) o Expected absorbed doses and effective whole body dose of 225Ac-PSMA · Direct effect of 225Ac-PSMA will be monitored by: o Changes in SUVmax of the target lesions on PET-MRI o Changes in perfusion measured on MRI · The preliminary action of the therapeutic doses of 225Ac-PSMA will be assessed according to the last PET-MRI. These imaging techniques will be used to derive the following endpoints where relevant: o Objective response rate (ORR) as measured by RECIST criteria v.1.1. This is defined as the number of patients with either a complete response (CR) or partial response (PR) at any time point which is confirmed a minimum of 4 weeks later, divided by the total number of patients with visceral disease at baseline. o Percent changes from baseline in tumor size where tumor size is defined as the sum of all target lesions as measured by RECIST 1.1. Only patients with measurable disease at baseline (i.e. target lesions identified and measured) will contribute to these analyses. o PSA response rate assessed from treatment visit 1 defined as a decrease in PSA of >= 50% from baseline. o Percent change from baseline in PSA as a continuous endpoint by visit and maximum reduction during the study o Percent change from baseline values of pain questionnaire at every treatment visit o Overall Survival defined as the time from the date of first dose of 225Ac-PSMA treatment to the date of death due to any cause. Any subject not known to have died at the time of the analysis will be censored based on the last recorded date on which the subject was known to be alive.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)