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

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

Status
Enrolling by invitation
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06864572
Enrollment
40
Registered
2025-03-07
Start date
2024-09-01
Completion date
2027-09-01
Last updated
2025-03-07

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

Conditions

Metastatic Prostate Cancer (mPC)

Brief summary

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_TESTP17-079, P16-093, or P15-041 PET/CT

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

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SUV0-180 min post-injectionmeasured by PET/CT

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026