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Enrolling by invitation NCT06864572

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

Early Phase I Interventional Metastatic Prostate Cancer (mPC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: P17-079, P16-093, or P15-041 PET/CT.
Who it may be relevant to
Registry conditions: Metastatic Prostate Cancer (mPC). Basic parameters: 18 years — 85 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • SUV [Time frame: 0-180 min post-injection]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT06864572 · PekingUMCH-NM-079

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗