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

Recruiting

• Conditions: prostate cancer; 10038597

• Registration Number: NL-OMON52446
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

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

- 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 <= 2·109/L,
platelet count <= 100·109/L, serum creatinine concentration >= 150 umol/L (>= 1.7
mg/dL), serum albumin <30 g/L
- Concurrent bladder outflow obstruction or unmanageable urinary incontinence
- Known or expected hypersensitivity to Gallium-68, Actinium-225, PSMA, or any
excipient present in 225Ac/68Ga-PSMA

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoints<br /><br>· Safety and tolerability of 225Ac-PSMA in patients with mCRPC as assessed by:<br /><br>o Incidence and severity of adverse events and serious adverse events<br /><br>o Absolute values and changes from baseline in laboratory parameters<br /><br>(hematology, blood chemistry and urinalysis), including assessment of shifts<br /><br>from baseline to abnormal values on treatment<br /><br>o Absolute values and changes from baseline in vital signs & ECG parameters</p><br>