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Dynamic Attribution of Hematologic Worsening Following ¹77Lu-PSMA-617 Therapy in Patients with Bone-Metastatic mCRPC: A Multicenter Retrospective Cohort Study

Dynamic Attribution of Hematologic Worsening Following ¹77Lu-PSMA-617 Therapy in Patients with Bone-Metastatic mCRPC: A Multicenter Retrospective Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00041134
Enrollment
300
Registered
2026-07-31
Start date
2026-03-18
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

C61

Interventions

Group 1: This is a multicenter retrospective observational cohort study. Clinical, laboratory, treatment, and imaging data will be collected from participating centers. Patients will be classified acc

Sponsors

Department of Nuclear Medicine University Hospital Halle (Saale)
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Histologically confirmed prostate adenocarcinoma. Metastatic castration-resistant prostate cancer (mCRPC) with bone metastases. Treatment with at least two cycles of 177Lu-PSMA-617 therapy. Availability of baseline clinical and laboratory data before treatment. At least one follow-up laboratory assessment after treatment. Sufficient clinical documentation for retrospective analysis.

Exclusion criteria

Exclusion criteria: Fewer than two treatment cycles. Missing key baseline or follow-up laboratory data. Follow-up insufficient for hematologic status assessment. Patients receiving concomitant treatments that independently caused severe hematologic toxicity (when identifiable).

Design outcomes

Primary

MeasureTime frame
What: Hematologic worsening attributable to disease progression or treatment. When: Evaluated during the first 3–4 treatment cycles and throughout follow-up. How: Data collected retrospectively from electronic medical records, laboratory results, treatment records, and PET/CT images.

Secondary

MeasureTime frame
Dynamic changes of hematologic and biochemical biomarkers Association between cumulative administered activity and hematologic changes Development and validation of dynamic attribution models Identification of disease-driven, treatment-driven, or mixed hematologic worsening

Countries

Germany

Contacts

Public ContactYushuang Hou

Department of Nuclear Medicine University Hospital Halle (Saale)

Yushuang.Hou@uk-halle.de+49 3455573463

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026