68Ga-PSMA PET/CT for Ra223 Assessment

NCT ID: NCT04951817

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2025-08-31

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

Detailed Description

It is a open-label single-arm clinical trial. Outcome measurement is the positivity rate of Ga68-PSMA-11 PET-defined progression and Bone Scan-defined progression. The primary objective is to compare the diagnostic positivity in progression of PSMA PET and BS. The 2×2 contingency table with four diagnostic outcomes (both positive, PET positive/BS negative, PET negative/BS positive, and both negative) will be conducted based on the enrolled subjects. Both diagnostic tools (Ga68-PSMA-11 PET and BS) are applied to a given set of individuals. Since both diagnostic tools will performed on each subject, then paired data result and methods that account for the correlated binary outcomes are necessary. McNemar's test will be used to compare the positivity of the two tools. Assuming that Ga68-PSMA-11 PET in patients detect more metastatic lesions/progression by 26.5% (i.e. p10-p01=0.265) and the discordant percentage is 38.5 % (i.e. p10+p01=0.385). Under the hypothesis H0: p10=p01, achieving an 80% power at the 5% of significance level, the sample size is 44. Based on expecting 15% of missing rate, the adjusted sample size will be 52. This calculation was done by PASS software (Power Analysis and Sample Size version 11.0.8, NCSS, Kaysville, Utah, USA).

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. The CT scan parameters were 120 kVp, 30 mA to 300 mA acquired with auto mA , 40× 0.625 collimator configuration, and pitch of 0.984 : 1. All images were reconstructed with a 500 mm field of view and a slice thickness of 5 mm. The PET acquisition time was 3 mins per bed position with maximum overlap (35 slices). Images were reconstructed using Q clear with beta value of 550, PSF correction, and non-TOF (QCHD-S). The matrix is 256 × 256. After image acquisition, the subject will be observed for half an hour, and will be discharged if no adverse event happens. EKG, blood and biochemistry test will be performed before and after first PET scan no more than two weeks. Except baseline Ga68-PSMA-11 PET/CT scan, patients will receive serial PET scans after 3rd injection of Ra-233 and 6th injection of Ra-223. All of the images were interpreted by an experienced nuclear medicine physicians.

Conditions

Metastatic Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ga68-PSMA ligand

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。

Group Type: EXPERIMENTAL

Ga-68 PSMA ligand

Intervention Type: 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.

Interventions

Ga-68 PSMA ligand

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.

Intervention Type: DRUG

Other Intervention Names

Ga68-PSMA-11 (Gallium-68 labeled HBED-CC PSMA)

Eligibility Criteria

Inclusion Criteria

1. Males with 40-85 years of age and life expectancy more than 3 months

2. 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)

3. Willing to sign the informed consent

4. ECOG performance status Grade 0-2

Exclusion Criteria

1. Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable.

2. With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.

3. Significant abnormal lab data (AST or ALT more than three times of normal value), and high risk to conduct examination after evaluations of PI.

4. Patient had previous other malignancy history

5. Patient experiences grade 3-4 neutropenia (neutrophil counts less than 1000/uL) or thrombocytopenia (platelet counts less than 50x103/uL) lasting > 14 days

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jing-Ren Tseng

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing-Ren Tseng, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital ,Linkou

Taoyuan, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jing-Ren Tseng, MD

Role: CONTACT

b9105019@gmail.com

0975-361-314

Facility Contacts

Jing-Ren Tseng, MD

Role: primary

b9105019@gmail.com

09753-61314

Other Identifiers

202002133A0

Identifier Type: -

Identifier Source: org_study_id