Using Ga-68 PSMA PET/CT to assess treatment response in metastatic prostate cancer
Using 68Ga-PSMA PET/CT for the Assessment of Osseous Tumor Burden in mCRPC Patients Undergoing 223Ra-dichloride Injections
This study is testing if a new type of scan can find cancer progression better than regular bone scans in men with metastatic prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | Male |
| Sponsor | Chang Gung Memorial Hospital Academic / other |
| Locations | 1 site (Taoyuan City) |
| Trial ID | NCT04951817 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of Ga-68 PSMA PET scans versus traditional bone scans in detecting disease progression in men with metastatic prostate cancer. It is an open-label, single-arm trial where participants will undergo both imaging techniques to evaluate their diagnostic positivity rates. The study will analyze the correlation between the PET-defined tumor burden and various laboratory markers, such as alkaline phosphatase and PSA levels. A total of 52 participants will be enrolled to ensure sufficient data for statistical analysis.
Who should consider this trial
Good fit: Ideal candidates are males aged 40-85 with metastatic castration-resistant prostate cancer and a life expectancy of more than three months.
Not a fit: Patients with significant renal impairment or those unable to tolerate PET/CT scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate method for monitoring treatment response in metastatic prostate cancer patients.
How similar studies have performed: Other studies have shown promising results using similar imaging techniques for assessing metastatic prostate cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taoyuan City
- Chang Gung Memorial Hospital ,Linkou — Taoyuan City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Jing-Ren Tseng, MD — Chang Gung Memorial Hospital
- Study coordinator: Jing-Ren Tseng, MD
- Email: b9105019@gmail.com
- Phone: 0975-361-314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.