Prostate CancerNCT03650946
Clinical Application of 68Ga-PSMA PET in Prostate Cancer
An observational study of Prostate Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Prostate cancer is the 7th leading cause of cancer death for men in Taiwan. It is important to identify the extent of disease extent to deliver adequate treatment, either for primary staging or in recurrence. Read more about this study
- Who is it for?
- Ages 40 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ga-68 PSMA PET
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2018to 30 Jul 2021
- Phase
- Observational
- 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 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Histologically confirmed prostate cancer
Who may be able to join
- Histologically confirmed prostate cancer
Who cannot join
- Patients with known malignancy in other organs.
- Patients with severe claustrophobia or unstable vital sigh
- Other serious comorbidities evaluated by primary investigator
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Ching Chu Lu, +886-2-23123456 ext. 65477, kelvinlu@ntu.edu.tw
About this study
Prostate cancer is the 7th leading cause of cancer death for men in Taiwan. It is important to identify the extent of disease extent to deliver adequate treatment, either for primary staging or in recurrence. However, conventional imaging techniques including computed tomography, bone scintigraphy, and immunoscintigraphy with 111In-capromab pendetide are not sensitive or specific enough to detect metastatic or recurrent disease. Although more widely applied, magnetic resonance still relies on size and shape criteria. 68Ga-PSMA is a new novel positron emission radiotracer which several preliminary data has shown to be effective of detecting recurrent or metastatic prostate cancer. These studies are confined to a small retrospective European population. In this study we aim to synthesize the novel tracer, find the usefulness of 68Ga-PSMA PET in detecting prostate cancer, including primary staging and recurrence, explore the relationship between imaging and clinical parameters, and seek the possibility of 68Ga-PSMA PET to predict tumor nature and prognosis.
Read the detailed description
Prostate cancer is the 7th leading cause of cancer death for men in Taiwan. It is important to identify the extent of disease extent to deliver adequate treatment, either for primary staging or in recurrence. However, conventional imaging techniques including computed tomography, bone scintigraphy, and immunoscintigraphy with 111In-capromab pendetide are not sensitive or specific enough to detect metastatic or recurrent disease. Although more widely applied, magnetic resonance still relies on size and shape criteria. 68Ga-PSMA is a new novel positron emission radiotracer which several preliminary data has shown to be effective of detecting recurrent or metastatic prostate cancer. These studies are confined to a small retrospective European population. In this study we aim to synthesize the novel tracer, find the usefulness of 68Ga-PSMA PET in detecting prostate cancer, including primary staging and recurrence, explore the relationship between imaging and clinical parameters, and seek the possibility of 68Ga-PSMA PET to predict tumor nature and prognosis.
- Conditions
- Prostate Cancer
- Being tested
- Ga-68 PSMA PET
- Keywords
- Prostate cancer, Ga-68 PSMA PET
- 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 PETDiagnostic test
Ga-68 PSMA PET
| Study group | Role | What they receive |
|---|---|---|
| 1 | men with high or intermediate risk localized disease who are about to undergo definitive surgery or radiotherapy Receives: Diagnostic Test: Ga-68 PSMA PET | |
| 2 | men with rising PSA after local definitive treatments Receives: Diagnostic Test: Ga-68 PSMA PET | |
| 3 | m0CRPC with a PSA >1.0 or 2.0 Receives: Diagnostic Test: Ga-68 PSMA PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
initial staging compared to pathology, clinical and follow-up result
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study startAug 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650946
- Sponsor's protocol ID
- 201508052MIND
- Status last verified
- May 2018
- First submitted
- 27 Aug 2018
- Last updated
- 29 Aug 2018
- 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 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of 68Ga-PSMA PET in Prostate Cancer
- ClinicalTrials.gov ID
- NCT03650946
- Acronym / sponsor ID
- 201508052MIND
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Ga-68 PSMA PET
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 29 Aug 2018 (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.
Prostate cancer is the 7th leading cause of cancer death for men in Taiwan. It is important to identify the extent of disease extent to deliver adequate treatment, either for primary staging or in recurrence. However, conventional imaging techniques including computed tomography, bone scintigraphy, and immunoscintigraphy with 111In-capromab pendetide are not sensitive or specific enough to detect metastatic or recurrent disease. Although more widely applied, magnetic resonance still relies on size and shape criteria. 68Ga-PSMA is a new novel positron emission radiotracer which several preliminary data has shown to be effective of detecting recurrent or metastatic prostate cancer. These studies are confined to a small retrospective European population. In this study we aim to synthesize the novel tracer, find the usefulness of 68Ga-PSMA PET in detecting prostate cancer, including primary staging and recurrence, explore the relationship between imaging and clinical parameters, and seek the possibility of 68Ga-PSMA PET to predict tumor nature and prognosis.
Detailed description
Prostate cancer is the 7th leading cause of cancer death for men in Taiwan. It is important to identify the extent of disease extent to deliver adequate treatment, either for primary staging or in recurrence. However, conventional imaging techniques including computed tomography, bone scintigraphy, and immunoscintigraphy with 111In-capromab pendetide are not sensitive or specific enough to detect metastatic or recurrent disease. Although more widely applied, magnetic resonance still relies on size and shape criteria. 68Ga-PSMA is a new novel positron emission radiotracer which several preliminary data has shown to be effective of detecting recurrent or metastatic prostate cancer. These studies are confined to a small retrospective European population. In this study we aim to synthesize the novel tracer, find the usefulness of 68Ga-PSMA PET in detecting prostate cancer, including primary staging and recurrence, explore the relationship between imaging and clinical parameters, and seek the possibility of 68Ga-PSMA PET to predict tumor nature and prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Ga-68 PSMA PETmen with high or intermediate risk localized disease who are about to undergo definitive surgery or radiotherapy |
| 2 | – | Diagnostic Test: Ga-68 PSMA PETmen with rising PSA after local definitive treatments |
| 3 | – | Diagnostic Test: Ga-68 PSMA PETm0CRPC with a PSA >1.0 or 2.0 |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically confirmed prostate cancer
Key inclusion criteria (1 listed)
- Histologically confirmed prostate cancer
Key exclusion criteria (3 listed)
- Patients with known malignancy in other organs.
- Patients with severe claustrophobia or unstable vital sigh
- Other serious comorbidities evaluated by primary investigator
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 PETGa-68 PSMA PET | Diagnostic test | 1, 2, 3 |
Primary outcome
Diagnostic accuracy
Time frame: 1 year
initial staging compared to pathology, clinical and follow-up result
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by National Taiwan University 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 1 inclusion and 3 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 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: 1 year). 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 2018.