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A single-arm pilot study to investigate tumor absorbed dose dynamics and feasibility of pre-treatment dosimetry with [177Lu]-PSMA-I&T in male participants aged ≥ 18 years with metastatic castration-resistant prostate cancer

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526519-12-00
Enrollment
3
Registered
2026-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-13

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

Conditions

Metastatic castration-resistant prostate cancer

Brief summary

Tumor dose per treatment cycle (post-therapeutic dosimetry)

Detailed description

Tumor dose per treatment cycle (pre-therapeutic dosimetry), Absolute and percentage changes from baseline in tumor volume and SUV, Incidence, severity, seriousness, and relationship to study intervention of adverse events and serious adverse events; clinically significant changes in laboratory parameters, vital signs, and physical examination findings, Exploratory: Association between tumor absorbed dose and changes from baseline in tumor volume and SUV, Exploratory: Changes from baseline in PET kinetic parameters and blood-based biomarkers

Interventions

Sponsors

Universitetssykehuset Nord-Norge HF
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Tumor dose per treatment cycle (post-therapeutic dosimetry)—

Secondary

MeasureTime frame
Tumor dose per treatment cycle (pre-therapeutic dosimetry), Absolute and percentage changes from baseline in tumor volume and SUV, Incidence, severity, seriousness, and relationship to study intervention of adverse events and serious adverse events; clinically significant changes in laboratory parameters, vital signs, and physical examination findings, Exploratory: Association between tumor absorbed dose and changes from baseline in tumor volume and SUV, Exploratory: Changes from baseline in PET kinetic parameters and blood-based biomarkers—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 14, 2026