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

NCT ID: NCT06864572

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2027-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Prostate Cancer (mPC)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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P17-079+P16-093

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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

P17-079+P15-041

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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PekingUMCH-NM-079

Identifier Type: -

Identifier Source: org_study_id

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