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Recruiting

NCT Number: NCT07096999

SPECT/CT Imaging for Dosimetry in 177Lu-PSMA-617 (Pluvicto) Therapy

This study is being performed to establish the association between absorbed dose to tumor and response and absorbed dose to normal organs and toxicity following Lu177-PSMA radioligand therapy

Recruiting

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Key information

Conditions

Metastatic Castration-resistant Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

James Pool

CONTACT

[email protected]

734-615-7391

Yuni K. Dewaraja

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • * 177Lu-617 PSMA treatment scheduled for mCRPC
  • Clinically stable as determined by the nuclear medicine clinicians
  • Male
  • ≥ 18 years of age
  • Willing and able to provide informed consent

Exclusion criteria

  • Patients who are unable to lie flat on the imaging systems long enough to permit imaging protocols to be performed

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Response and toxicity following 177Lu-RLT

    Time frame: Up to 4 years

    Association between absorbed dose and effect (response/toxicity) following 177Lu-RLT

Secondary outcomes

  1. Build and test models

    Time frame: Up to 4 years

    Build and test models for predicting therapy delivered absorbed dose from pre-therapy PET imaging/non-imaging biomarkers.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Jul 31, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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