Actively Recruiting
Using 68Ga-PSMA PET/CT to Assess Bone Tumor Burden in Men with Metastatic Castration-Resistant Prostate Cancer Receiving 223Ra-dichloride Injections
Led by Chang Gung Memorial Hospital · Updated on 2025-08-29
52
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of two diagnostic imaging methods, 68Ga-PSMA PET and Bone Scan, in detecting the progression of metastatic castration-resistant prostate cancer (mCRPC) in men aged 40 to 85. The study aims to compare how often each imaging tool identifies cancer progression and to explore relationships between PET tumor burden and certain blood markers. This is an open-label, single-arm clinical trial sponsored by Chang Gung Memorial Hospital. Participants will receive intravenous injections of a radioactive tracer called Ga68-PSMA-11, followed by PET/CT scans performed on a specialized imaging system. Each participant undergoes a baseline PET/CT scan before treatment and additional scans after the third and sixth injections of 223Ra-dichloride therapy. Bone scans are also done for comparison. The imaging and diagnostic results will be analyzed to assess differences in lesion detection between the two methods. During the study, participants will have blood tests, EKGs, and biochemistry assessments before and after their first PET scan. They will be monitored for any adverse events immediately following imaging. Experienced nuclear medicine physicians will interpret all images. The main outcome measured is the change in the number of detected lesions on PET imaging at approximately 9 to 23 weeks. Participants will be observed throughout the study, which continues until August 2025.
CONDITIONS
Brief Title
68Ga-PSMA PET/CT for Ra223 Assessment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males aged 40 to 85 years with life expectancy more than 3 months
- Diagnosed with metastatic castration-resistant prostate cancer and meet criteria for 223Ra-dichloride use (symptomatic bone metastasis, at least two bone metastasis sites, no visceral organ metastasis)
- Willing to sign informed consent
- ECOG performance status Grade 0 to 2
You will not qualify if you...
- Unable to tolerate PET/CT scan (e.g., claustrophobia, unable to lie still, unclear consciousness, unstable vital signs)
- Renal impairment with glomerular filtration rate below 30 ml/min/1.73 m2 or allergy to contrast medium
- Significant abnormal liver lab results (AST or ALT more than three times normal) or high risk for examination
- History of other malignancies
- Grade 3-4 neutropenia (neutrophil count less than 1000/uL) or thrombocytopenia (platelet count less than 50x10^3/uL) lasting more than 14 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 to 23 weeks
Participants undergo PET/CT PSMA scans with intravenous administration of 68Ga-PSMA-11 to assess bone tumor burden.
3 visits (in-person) for PET/CT scans: baseline, after 3rd injection of Ra-223, and after 6th injection of Ra-223
Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital ,Linkou
Taoyuan City, Taiwan, 333
Actively Recruiting
Research Team
J
Jing-Ren Tseng, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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