Metastatic Prostate CancerNCT03977610
The Role of Ga68-PSMA-11 PET Imaging in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
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
This is an open-label single arm clinical trial, Plan to enroll approximately a total of 43 evaluable subjects. According to the estimated missing rate 15%, the sample size in this study is 51. Inclusion criteria: To be eligible for inclusion, each patient must fulfill all of the following criteria: 1. 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
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2019to 27 Jul 2021
- 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
- Pathology-proved prostate cancer patients and classified as clinical stage III or IV (including lymph node or bone metastasis)
- Willing to sign the informed consent
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 malignancy history
- Patient had known allergy history or is probably allergy to Ga68-PSMA-11
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label single arm clinical trial, Plan to enroll approximately a total of 43 evaluable subjects. According to the estimated missing rate 15%, the sample size in this study is 51.
Inclusion criteria:
Read more
To be eligible for inclusion, each patient must fulfill all of the following criteria:
- Males with 40-85 years of age and life expectancy more than 3 months
- Pathology-proved prostate cancer patients and classified as clinical stage III or IV (including lymph node or bone metastasis)
- Willing to sign the informed consent
Exclusion criteria:
Patient who has any of the following criteria will be excluded from the trial:
- 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 malignancy history
- Patient had known allergy history or is probably allergy to Ga68-PSMA-11
Read the detailed description
It is a single-arm clinical trial. The primary endpoint is diagnostic positivity rate of Ga68-PSMA-11 in metastasis lesion. Sample size calculation is performed using two-sided one-proportion test to achieving an 82% power at the 5% level of significance. The primary measurement of positivity can be obtained for the one-proportion test with statistical hypotheses H0: P = P0 versus H1: P≠P0. We assume the alternative positivity rate is 65.9% and the null positivity rate is 43.9% which is the reference value from Maurer T et al (J Urol. 2016;195:1436-1443). Thus, the sample size needed is 43. According to the estimated missing rate 15%, the sample size in this study is 51. The sample size calculation was performed using PASS software (Power Analysis and Sample Size version 11.0.8, NCSS, Kaysville, Utah, USA). All subjects enrolled must meet eligibility criteria based on the inclusion/exclusion criteria detailed in Section 5.4 and 5.5.
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. The data acquisition begin with non-contrast CT at 120kVp, automated mAs, and a pitch of 1.5, followed by PET acquisition from the mid-thigh to skull-base, 3 minutes each bed. 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 scan no more than two weeks. Patient will underwent two times of PSMA-11 PET/CT scans before and under androgen deprivation therapy within a 10-14 weeks interval. In the follow up period, if metastatic castration-resistance status happens, patient may underwent optional PSMA-11 PET/CT scan by attending's discrimination in order to give appropriate treatment suggestions.
Time elapsed from the last PSA determination until PET scan was no more than 6 weeks in all patients. Patients will receive complementary workups. All of the images were interpreted by a team of two nuclear medicine physicians and one radiologist. In cases of questionable findings, the decision was made by consensus of at least two observers using pre-specified criteria. For patients with discrepancy image findings between each modality, biopsy results may be taken into consideration to determine the final status.
- Conditions
- Metastatic Prostate Cancer
- Being tested
- Ga-68 PSMA ligand
- Keywords
- Prostate cancer, Androgen deprivation therapy, Ga-68 PSMA Ligand, Treatment response
- 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 PSMA PET/CT 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. Patient will underwent two times of PSMA-11 PET/CT scans before and under androgen deprivation therapy within a 10-14 weeks interval.
| Study group | Role | What they receive |
|---|---|---|
| Ga68-PSMA ligand | Experimental | Glass vial with 4~20 mCi(148-740 MBq) of 68Ga-PSMA ligand in ≤10% EtOH with aqueous sterile water for injection solution (approximately 15.5 mL), more than 0.33 mCi/mL @ EOS; One time dose of 2-5 mCi (74-185 MBq) for PET Imaging ; i.v. injection 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 androgen deprivation therapy on the PSMA PET imaging with a time interval 10-14 weeks
Measured: 10-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 Jun 2019
- Primary completion27 Jul 2021
- Study completion27 Jul 2021
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
- 46 participants (actual)
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
- NCT03977610
- Sponsor's protocol ID
- 201801384A0
- Status last verified
- Jul 2021
- First submitted
- 5 Jun 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ga68-PSMA-11 PET Imaging in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT03977610
- Acronym / sponsor ID
- 201801384A0
- Conditions
- Metastatic Prostate Cancer
- Keywords
- Prostate cancer, Androgen deprivation therapy, Ga-68 PSMA Ligand, Treatment response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 6 Jun 2019 (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.
This is an open-label single arm clinical trial, Plan to enroll approximately a total of 43 evaluable subjects. According to the estimated missing rate 15%, the sample size in this study is 51.
Inclusion criteria:
To be eligible for inclusion, each patient must fulfill all of the following criteria:
- Males with 40-85 years of age and life expectancy more than 3 months
- Pathology-proved prostate cancer patients and classified as clinical stage III or IV (including lymph node or bone metastasis)
- Willing to sign the informed consent
Exclusion criteria:
Patient who has any of the following criteria will be excluded from the trial:
- 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 malignancy history
- Patient had known allergy history or is probably allergy to Ga68-PSMA-11
Detailed description
It is a single-arm clinical trial. The primary endpoint is diagnostic positivity rate of Ga68-PSMA-11 in metastasis lesion. Sample size calculation is performed using two-sided one-proportion test to achieving an 82% power at the 5% level of significance. The primary measurement of positivity can be obtained for the one-proportion test with statistical hypotheses H0: P = P0 versus H1: P≠P0. We assume the alternative positivity rate is 65.9% and the null positivity rate is 43.9% which is the reference value from Maurer T et al (J Urol. 2016;195:1436-1443). Thus, the sample size needed is 43. According to the estimated missing rate 15%, the sample size in this study is 51. The sample size calculation was performed using PASS software (Power Analysis and Sample Size version 11.0.8, NCSS, Kaysville, Utah, USA). All subjects enrolled must meet eligibility criteria based on the inclusion/exclusion criteria detailed in Section 5.4 and 5.5.
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. The data acquisition begin with non-contrast CT at 120kVp, automated mAs, and a pitch of 1.5, followed by PET acquisition from the mid-thigh to skull-base, 3 minutes each bed. 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 scan no more than two weeks. Patient will underwent two times of PSMA-11 PET/CT scans before and under androgen deprivation therapy within a 10-14 weeks interval. In the follow up period, if metastatic castration-resistance status happens, patient may underwent optional PSMA-11 PET/CT scan by attending's discrimination in order to give appropriate treatment suggestions.
Time elapsed from the last PSA determination until PET scan was no more than 6 weeks in all patients. Patients will receive complementary workups. All of the images were interpreted by a team of two nuclear medicine physicians and one radiologist. In cases of questionable findings, the decision was made by consensus of at least two observers using pre-specified criteria. For patients with discrepancy image findings between each modality, biopsy results may be taken into consideration to determine the final status.
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 4~20 mCi(148-740 MBq) of 68Ga-PSMA ligand in ≤10% EtOH with aqueous sterile water for injection solution (approximately 15.5 mL), more than 0.33 mCi/mL @ EOS; One time dose of 2-5 mCi (74-185 MBq) for PET Imaging ; i.v. injection |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males with 40-85 years of age and life expectancy more than 3 months
- Pathology-proved prostate cancer patients and classified as clinical stage III or IV (including lymph node or bone metastasis)
- Willing to sign the informed consent
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 malignancy history
- Patient had known allergy history or is probably allergy to Ga68-PSMA-11
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 PSMA PET/CT 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. Patient will underwent two times of PSMA-11 PET/CT scans before and under androgen deprivation therapy within a 10-14 weeks interval. | Drug | Ga68-PSMA ligand |
Primary outcome
Change of lesion detection number by PET imaging
Time frame: 10-14 weeks
Lesion detection number before and under androgen deprivation therapy on the PSMA PET imaging with a time interval 10-14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
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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 3 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: finished, as of the sponsor's last update on 28 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of lesion detection number by PET imaging (time frame: 10-14 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 28 Jul 2021.