Biochemical Relapse Fo Malignant Neoplasm of ProstateNCT05048537
18F-FACBC PET/CT and the PSA Kinetics for PCa Patients With Biochemical Recurrence.
A study testing 18F-FACBC PET/CT in people with Biochemical Relapse Fo Malignant Neoplasm of Prostate, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Prostate cancer (PCa) is the fifth-most common cancer for male with a seventh highest cancer-related death in Taiwan. Currently, the incidence and mortality rate are still increasing rapidly. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Biochemical Relapse Fo Malignant Neoplasm of Prostate
- What is being tested?
- 18F-FACBC PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Mar 2021to 12 Nov 2023
- 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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PCa patients with BCR
- Serum PSA data and pathologic report
- Agreement consent
Who cannot join
- Claustrophobia and unstable vital signs
- Disagreement
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yi-Hsien Chou, MD, 097252572, Y06922@ms1.ylh.gov.tw
About this study
Official title: The Correlation Between the Detection Rate of 18F-FACBC PET/CT and the PSA Kinetics for Prostate Cancer Patients With Biochemical Recurrence.
Prostate cancer (PCa) is the fifth-most common cancer for male with a seventh highest cancer-related death in Taiwan. Currently, the incidence and mortality rate are still increasing rapidly. The treatment decision planning is made up by clinical charts like Gleason score (GS), TNM stage and serum prostate-specific antigen (PSA) level. However, after definitive therapy for PCa with either external beam radiotherapy (EBRT) or radical prostatectomy (RP), up to half patients experience biochemical recurrence (BCR). Although not all patients with BCR proceed to develop disease progression, it is important to identify early lesion to initiate salvage treatment.
Anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (18F-FACBC) positron emission tomography (PET) is a imaging marker for L-amino acid transport evaluation. Many cancers including PCa have up-regulated amino acid transport tied to their proliferative potential. Recently, 18F-FACBC was included in the National Comprehensive Cancer Network (NCCN) guidelines for the management of recurrent PCa patients. As we know, PSA level and PSA kinetics are valuable for the prediction of recurrence. The objective of this study is to investigate the correlation between the detection rate of 18F-FACBC PET/CT and the PSA kinetics for PCa patients with BCR.
- Being tested
- 18F-FACBC PET/CT
- Keywords
- Prostate cancer, 18F-FACBC, Biochemical recurrence
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FACBC PET/CTRadiation
10mCi 18F-FACBC IV injection, then whole body PET/CT after 4 mins
| Study group | Role | What they receive |
|---|---|---|
| 18F-FACBC PET/CT and the PSA kinetics for PCa patients with BCR. | Other | Not described Receives: Radiation: 18F-FACBC PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection rate of 18F-FACBC PET/CT
The correlation between the positive/negative results of 18F-FACBC scans and the PSA kinetics in prostate cancer patients with biochemical recurrence.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start26 Mar 2021
- Primary completion12 Nov 2023 (estimated)
- Study completion12 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biochemical Relapse Fo Malignant Neoplasm of ProstateStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Hsien Chou, MD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048537
- Sponsor's protocol ID
- 202010009MIND
- Status last verified
- Nov 2021
- First submitted
- 1 Sep 2021
- Last updated
- 22 Sep 2022
- 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 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between the Detection Rate of 18F-FACBC PET/CT and the PSA Kinetics for Prostate Cancer Patients With Biochemical Recurrence.
- ClinicalTrials.gov ID
- NCT05048537
- Acronym / sponsor ID
- 202010009MIND
- Keywords
- Prostate cancer, 18F-FACBC, Biochemical recurrence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 12 Nov 2023 (estimated)
- Study completion
- 12 Nov 2023 (estimated)
- First posted
- 17 Sep 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.
Prostate cancer (PCa) is the fifth-most common cancer for male with a seventh highest cancer-related death in Taiwan. Currently, the incidence and mortality rate are still increasing rapidly. The treatment decision planning is made up by clinical charts like Gleason score (GS), TNM stage and serum prostate-specific antigen (PSA) level. However, after definitive therapy for PCa with either external beam radiotherapy (EBRT) or radical prostatectomy (RP), up to half patients experience biochemical recurrence (BCR). Although not all patients with BCR proceed to develop disease progression, it is important to identify early lesion to initiate salvage treatment.
Anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (18F-FACBC) positron emission tomography (PET) is a imaging marker for L-amino acid transport evaluation. Many cancers including PCa have up-regulated amino acid transport tied to their proliferative potential. Recently, 18F-FACBC was included in the National Comprehensive Cancer Network (NCCN) guidelines for the management of recurrent PCa patients. As we know, PSA level and PSA kinetics are valuable for the prediction of recurrence. The objective of this study is to investigate the correlation between the detection rate of 18F-FACBC PET/CT and the PSA kinetics for PCa patients with BCR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FACBC PET/CT and the PSA kinetics for PCa patients with BCR. | Other | Radiation: 18F-FACBC PET/CT |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PCa patients with BCR
- Serum PSA data and pathologic report
- Agreement consent
Key exclusion criteria (2 listed)
- Claustrophobia and unstable vital signs
- Disagreement
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 |
|---|---|---|
| 18F-FACBC PET/CT10mCi 18F-FACBC IV injection, then whole body PET/CT after 4 mins | Radiation | 18F-FACBC PET/CT and the PSA kinetics for PCa patients with BCR. |
Primary outcome
The detection rate of 18F-FACBC PET/CT
Time frame: 30 minutes
The correlation between the positive/negative results of 18F-FACBC scans and the PSA kinetics in prostate cancer patients with biochemical recurrence.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
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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.
Yi-Hsien Chou, MD study director
National Taiwan University 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 18F-FACBC PET/CT in people with Biochemical Relapse Fo Malignant Neoplasm of Prostate, 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 3 inclusion and 2 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 22 Sep 2022. 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 Yi-Hsien Chou, MD (+886-97252572, Y06922@ms1.ylh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection rate of 18F-FACBC PET/CT (time frame: 30 minutes). 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 22 Sep 2022.