Metastatic Prostate CancerNCT04951817
68Ga-PSMA PET/CT for Ra223 Assessment
A study testing Ga-68 PSMA ligand in people with Metastatic Prostate Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Metastatic Prostate Cancer
- What is being tested?
- Ga-68 PSMA ligand
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Mar 2022to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital ,Linkou
Taoyuan City, 333
Jing-Ren Tseng, MD, 09753-61314, b9105019@gmail.com
About this study
Official title: Using 68Ga-PSMA PET/CT for the Assessment of Osseous Tumor Burden in mCRPC Patients Undergoing 223Ra-dichloride Injections
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
Read the 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
- Being tested
- Ga-68 PSMA ligand
- Keywords
- Prostate Cancer, Treatment response, Ra223, Ga-68 PSMA Ligand, Bone scan
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-68 PSMA ligandDrug
Also called Ga68-PSMA-11 (Gallium-68 labeled HBED-CC PSMA)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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。 Receives: Drug: Ga-68 PSMA ligand |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 9-11 weeks or 21-23 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start2 Mar 2022
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing-Ren Tseng, Chang Gung Memorial Hospital
- Investigators
- Jing-Ren Tseng, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951817
- Sponsor's protocol ID
- 202002133A0
- Status last verified
- Aug 2024
- First submitted
- 30 Jun 2021
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using 68Ga-PSMA PET/CT for the Assessment of Osseous Tumor Burden in mCRPC Patients Undergoing 223Ra-dichloride Injections
- ClinicalTrials.gov ID
- NCT04951817
- Acronym / sponsor ID
- 202002133A0
- Conditions
- Metastatic Prostate Cancer
- Keywords
- Prostate Cancer, Treatment response, Ra223, Ga-68 PSMA Ligand, Bone scan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ga68-PSMA ligand | Experimental | Drug: Ga-68 PSMA ligandGlass 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。 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga-68 PSMA ligandAlso: Ga68-PSMA-11 (Gallium-68 labeled HBED-CC PSMA)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. | Drug | Ga68-PSMA ligand |
Primary outcome
Change of lesion detection number by PET imaging
Time frame: 9-11 weeks or 21-23 weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing-Ren Tseng, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ga-68 PSMA ligand in people with Metastatic Prostate Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing-Ren Tseng, MD (0975-361-314, b9105019@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of lesion detection number by PET imaging (time frame: 9-11 weeks or 21-23 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.