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

NCT06864572 | Enrolling By Invitation Early Phase 1

• 1 other identifier: PekingUMCH-NM-079
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Prostate Cancer (mPC)

Outcome Measures

Primary Outcomes (1)

• SUV

  measured by PET/CT

  0-180 min post-injection

Study Arms (2)

P17-079+P16-093

EXPERIMENTAL

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

P17-079+P15-041

EXPERIMENTAL

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

Interventions

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

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

P17-079+P15-041; P17-079+P16-093

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 7, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 7, 2025

Record last verified: 2024-09

Locations

CN (1)