68Ga-PSMA PET/CT for Ra223 Assessment

NCT04951817 | Recruiting

• 1 other identifier: 202002133A0
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Primary objective: i.The primary objective is to compare the diagnostic positivity in progression of 68Ga-PSMA PET and Bone scan. Secondary objectives: i.The correlation between PET osseous tumor burden index and Alk-P level ii.The correlation between PET osseous tumor burden index and PSA level

Conditions

Metastatic Prostate Cancer

Keywords

Prostate Cancer; Treatment response; Ra223; Ga-68 PSMA Ligand; Bone scan

Outcome Measures

Primary Outcomes (1)

• Change of lesion detection number by PET imaging

  Lesion detection number before and under Ra223 therapy on the PSMA PET imaging with a time interval 9-11 weeks and/or 21-23 weeks

  9-11 weeks or 21-23 weeks

Study Arms (1)

Ga68-PSMA ligand

EXPERIMENTAL

Glass vial with 5\~20 mCi(185-740 MBq) of 68Ga-PSMA ligand in ≤10% EtOH with aqueous sterile water for injection solution (approximately 15.5 mL), ≧ 0.33 mCi/mL @ EOS。

Drug: Ga-68 PSMA ligand

Interventions

Ga-68 PSMA ligand DRUG

For PET/CT PSMA scan, the subject will have catheter(s) placed for intravenous administration of \[68Ga\]PSMA-11. Subjects will receive a single intravenous bolus of 2-5 mCi \[68Ga\]PSMA-11 and received PET/CT scan 60 minutes later.PSMA PET-CT scan was performed on a GE Discovery MI PET/CT system.

Also known as: Ga68-PSMA-11 (Gallium-68 labeled HBED-CC PSMA)

Ga68-PSMA ligand

Eligibility Criteria

• Age: 40 Years - 85 Years
• Gender Eligibility Details: Male patient only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males with 40-85 years of age and life expectancy more than 3 months
• Patient was diagnosed as mCRPC, and meet the standard criteria of using 223Ra-dichloride (symptomatic bone metastasis, at least two bone metastasis sites, no visceral organ metastasis)
• Willing to sign the informed consent
• ECOG performance status Grade 0-2

You may not qualify if:

• Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable.
• With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
• Significant abnormal lab data (AST or ALT more than three times of normal value), and high risk to conduct examination after evaluations of PI.
• Patient had previous other malignancy history
• Patient experiences grade 3-4 neutropenia (neutrophil counts less than 1000/uL) or thrombocytopenia (platelet counts less than 50x103/uL) lasting \> 14 days

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital ,Linkou

Taoyuan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

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 Officials

• Jing-Ren Tseng, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing-Ren Tseng, MD

CONTACT

0975-361-314; b9105019@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 7, 2021
• Study Start: March 2, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 29, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)