68Ga-PSMA PET/CT for Ra223 Assessment
Using 68Ga-PSMA PET/CT for the Assessment of Osseous Tumor Burden in mCRPC Patients Undergoing 223Ra-dichloride Injections
About This Trial
- This study is comparing a specialized body scan with standard bone scans to see which one better detects if prostate cancer has grown or spread in the bones.
- It is open to men aged 40 to 85 who have advanced prostate cancer that has spread to their bones, but not to other organs, and who qualify for a targeted bone radiation treatment.
- Before taking part, you should know that the study requires undergoing imaging tests, so you must be comfortable lying still inside a scanner.
- Additionally, you may not be eligible if you have severe kidney or liver disease, significantly low blood cell counts, or a history of other cancers.
More Information
- 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
Who Can Enroll
- Age Range: 40 - 85 years
- Gender: Male
- Who This Trial is For: This study is comparing a specialized body scan with standard bone scans to see which one better detects if prostate cancer has grown or spread in the bones.
Study Details
- Start Date: March 2, 2022
- Lead Sponsor: Chang Gung Memorial Hospital
Full Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Treatments
- Drug: Ga-68 PSMA ligand