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Enrolling by Invitation

NCT Number: NCT06864572

[68Ga]Ga-P17-079 in the Diagnosis and Treatment of Metastatic Prostate Cancer

Preclinical studies have confirmed that [68Ga]Ga-P17-079 in both mouse prostate tumors and osseogenic metastases has high uptake and prolonged retention, which enables [68Ga]Ga-P17-079 to be fully absorbed by the lesions, and it is possible to detect bone metastases, prostate cancer primary sites, lymph node metastases and organ metastases at the same time in a single examination. It is a potential "killing two birds with one stone" imaging agent. At this stage, the clinical study of [68Ga]Ga-P17-079 in the diagnosis and treatment of metastatic prostate cancer as a self-made preparation is planned to be carried out in our hospital to further verify its clinical application value.

Enrolling by Invitation

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Key information

Age range

18 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male aged 18-85 years, expected survival ≥12 weeks.
  • Patients who have not undergone chemoradiotherapy, feasible surgery or biopsy to obtain a pathological diagnosis or are highly suspected of malignancy according to clinical diagnostic criteria.
  • At least one measurable target lesion was present according to RECIST1.1 criteria.
  • Obtain written informed consent and be able to follow up

Exclusion criteria

  • Severe abnormal liver and kidney function
  • Fertile subjects will need to use effective contraception during the study
  • Unable to lie flat for half an hour
  • Refused to join this clinical investigator
  • Suffering from claustrophobia or other mental illness
  • Other conditions deemed unsuitable for participation in the trial

Treatment and study plan

P17-079, P16-093, or P15-041 PET/CT

Diagnostic Test

P17-079, P16-093, or P15-041 PET/CT

Primary outcomes

  1. SUV

    Time frame: 0-180 min post-injection

    measured by PET/CT

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Clinical Application of Dual-target Imaging Agent [68Ga]Ga-P17-079 in the Diagnosis and Treatment of Metastatic Prostate Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

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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