Prostatic NeoplasmsNCT04521894
The Application Value of 18F-prostate-specific Membrane Antigen PET/CT in Prostate Cancer
An observational study of Prostatic Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Prostate cancer (PCa) is the most common type of malignant tumor and the third leading cause of cancer-associated mortality among men worldwide. The biological behaviors of PCa at different degrees of malignancy also largely differ, directly impacting disease outcomes and responses to treatment. Read more about this study
- Who is it for?
- Ages 40 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Positron emission tomography/computerized tomography (PET/CT)
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2021to 31 Aug 2023
- 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 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Prostate cancer, benign prostatic hyperplasia, and healthy volunteers who are pathologically confirmed in the First Affiliated Hospital of Xi'an Jiaotong University due to elevated PSA levels or clinical symptoms will include in this study, with complete clinical and pathological data, and complete PET/CT scan before receiving treatment.
Who may be able to join
- 1 age between 40 and 100 years old
- 2 PSA >0.4 ng/mL for primary PCa with biopsy proven or RP diagnosis of prostate cancer
- 3 PSA >0.2 ng/mL after RP, PSA ≥2 ng/mL above the nadir after EBRT) or persisting PSA after radical treatment with rising PSA values
- 4 complete clinical, pathological, imaging and biochemical information
Who cannot join
- 1 lack of histological examinationproven diagnosis of PCa
- 2 18F-PSMA PET/CT being performed after pharmacotherapy since PSMA-targeted imaging can be disturbed by previous therapie
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliate Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Zhuonan Wang, Ph.D.
About this study
Official title: Diagnostic Performance of 18F-prostate-specific Membrane Antigen-1007 PET/CT in the Detection of Prostate Cancer
Prostate cancer (PCa) is the most common type of malignant tumor and the third leading cause of cancer-associated mortality among men worldwide. The biological behaviors of PCa at different degrees of malignancy also largely differ, directly impacting disease outcomes and responses to treatment. Therefore, accurate risk stratification of PCa before treatment and the development of an individualized treatment regimen, play a vital role to improve the clinical outcome of patients. However, overdiagnosis and unnecessary biopsies, which are invasive examinations associated with higher costs and adverse effects. When the PSA is less than 20ng/mL, less than 1% of PCa patients have a positive bone scan, and routine bone scans are not recommended for asymptomatic or low-risk PCa patients. Interestingly, due to the variations among evaluators that often occur when defining the T stage, biopsies operate inaccuracy, also low-PSA level can also occur metastasis, there is a need for an objective and accurate imaging biomarker for the diagnosis of different grade PCa.
Prostate-specific membrane antigen (PSMA) is a type II transmembrane protein, which has higher expression in cancerous prostate cells than in normal prostate cells. Meanwhile, its expression level is positively correlated with the degree of malignancy, the tendency of metastasis, and the risk of early recurrence. In recent years, 18F-PSMA positron emission tomography/computerized tomography (PSMA PET/CT) has earned widespread attention as a novel imaging modality based on molecular-level analysis, rather than morphological or physiological analysis, to assist in PCa diagnosis and tumor burden evaluation.
Currently, Maximum Standardized Uptake Value (SUVmax) is the most commonly used semi-quantitative parameter in PET/CT, which is used to assess tumor burden of PCa, and thus can be used as an imaging biomarker to assess the degree of malignancy of prostate cancers. However, prior studies mainly focused on the correlation between patients' biochemical recurrence lesions and the PSA levels and Gleason score. There is a lack of research to explore the correlation among primary PCa burden, PSA levels, and the degree of prostate cancer malignancy. The aim of this project is to use 18F-PSMA PET/CT SUVmax to analyze the correlation among primary PCa imaging, and clinical indicators, and to evaluate the predictive value for PCa risk stratification, metastasis risk, and biochemical recurrence.
Read the detailed description
Prostate cancer (PCa) is the highest malignant male tumor and one of the leading causes of mortality among men worldwide. The biological behaviors of PCa malignancy are largely heterogeneous, directly impacting prognostic grouping and treatment options. In addition, assessments of the distant metastatic status for PCa patients have recently received increasing attention due to the heightening mortality rate. Therefore, the precise systemic staging of primary PCa risk stratification before treatment plays a crucial role in designing the management strategy for the individualized treatment option. According to both American Urological Association (AUA) and the European Association of Urology (EAU) guidelines, patients with total prostate-specific antigen (tPSA) > 20 ng/mL and/or Gleason Score ≥ 8 are high-risk, the probability of distant metastasis and mortality will increase significantly and may not suitable for active surveillance programs, radical prostatectomy or radiotherapy treatment. However, tPSA is organ-specific but not tumor-specific, the biological behaviors of prostate malignancy are largely heterogeneous, and the specificity of the ability of tPSA to reflect distant metastasis remains debatable. Using tPSA as the only indicator for risk stratification discrimination and distant metastases prediction may causing in large numbers of unnecessary prostate biopsies. Also, elderly patients with severe comorbidities or undergoing anticoagulation therapy may not be the optimal candidates for biopsies and may cause adverse effects and higher costs. In these cases, it is urgent to find objective and accurate imaging biomarkers for risk stratification classification with a noninvasive approach based on imaging analysis.
The prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that is primarily expressed in prostatic tissues, and its expression is correlated with the degree of malignancy and further increases in metastatic. The ability of PSMA to easily penetrate tissues and diffuse with solid tumor lesions can reflect the statuses of metastasis. Prior studies show that PSMA PET/CT is superior to conventional imaging methods for lymph node metastatic detection and that the pre-treatment tPSA level and Gleason Score are associated with the PSMA uptake in primary PCa. Furthermore, the Maximum Standardized Uptake Value (SUVmax) is the most commonly used semi-quantitative parameter in PET/CT and prior studies have already been used to assess the degree of malignancy of PCa and predict extended pelvic lymph node metastases in intermediate to high-risk PCa patients by 68Ga-PSMA-11 or 68Ga-PSMA-617. 18F-PSMA-1007 is advantaged by its higher spatial resolution images and non-urinary excretion that reduces urinary clearance, this approach bears a great potential to facilitate the detection of primary PCa and metastatic lesions. However, to our knowledge, no prior studies have employed 18F-PSMA-1007 PET/CT to evaluate the diagnostic performance in risk stratification and distant metastases prediction in primary PCa.
The present study aims to retrospective investigated the role of 18F-PSMA-1007 PET/CT semi-quantitative parameters correlation among newly diagnosed PCa imaging, tPSA levels and Gleason Score, and to evaluate the prediction performance of 18F-PSMA-1007 PET/CT and clinicopathologic characteristics on PCa risk stratification and distant metastatic prediction.
- Conditions
- Prostatic Neoplasms
- Being tested
- Positron emission tomography/computerized tomography (PET/CT)
- Keywords
- Prostate-specific antigen, PET/CT, PSMA, Gleason Score
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron emission tomography/computerized tomography (PET/CT)Device
- Genetic factors and age: Epidemiological studies have shown that if an immediate family member (brother or father) suffers from prostate cancer, the risk of prostate cancer will be more than doubled. Age is a relatively strong risk factor for PCa.
- Prostatitis: Prostatitis is related to PCa. Cancer is usually found in the tissues where inflammation is found.
- Obesity: Research has found that obese patients have a low grade of PCa, but their risk of developing aggressive cancer is higher.
- Infection:
- Exercise: Most studies have found that exercise does not reduce the risk of prostate cancer, but some studies have shown that.
- Daily diet: The corrective mechanism of diet in PCa is not very clear.
- Drinking history:
| Study group | Role | What they receive |
|---|---|---|
| Primary PCa without metastases Group | Participants who are suspected of prostate cancer due to elevated PSA or clinical symptoms but have not received any treatment and eventually confirmed prostate cancer after surgery or biopsies. Receives: Device: Positron emission tomography/computerized tomography (PET/CT) | |
| Primary PCa with metastases Group | Participants who are suspected of prostate cancer due to elevated PSA or clinical symptoms but have not received any treatment and eventually confirmed prostate cancer after surgery or biopsies. And the 18F-PSMA-PET/CT scan confirmed metastases. Receives: Device: Positron emission tomography/computerized tomography (PET/CT) | |
| Oligometastatic PCa group | "Oligometastatic"is a subgroup of metastatic patients with a limited number of secondary lesions (threshold ranging from 3 to 5) in one or few organs. Receives: Device: Positron emission tomography/computerized tomography (PET/CT) | |
| Biochemical recurrence Group | Proven biochemical recurrence after radical therapy (PSA >0.2 ng/mL after radical prostatectomy, PSA ≥2 ng/mL above the nadir after external-beam radiotherapy) or persisting PSA after radical treatment with rising PSA values. Receives: Device: Positron emission tomography/computerized tomography (PET/CT) | |
| Control Group | Prostate cancer benign prostatic hypertrophy or normal prostate. Receives: Device: Positron emission tomography/computerized tomography (PET/CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax
Maximum Standardized Uptake Value (SUVmax) is the most commonly used semi-quantitative parameter in PET/CT, which is used to assess tumor burden of PCa.
Measured: From the time the participants first go to the hospital without treatment and through study completion, an average of 1 year. If the patient undergoes radical prostatectomy, an additional scan will be added within 1 month after surgery
PSA
Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood.
Measured: Through study completion, an average of 6 months
Gleason Score
The cells are graded on a scale of 1 to 5. Grade 1 cells resemble normal prostate tissue. Cells closest to 5 are considered "high-grade" and have mutated so much that they barely resemble normal cells.
Measured: Baseline of the study by prostate cancer biopsies or after radical prostatectomy, and when there is a biochemical recurrence, an additional biopsies the prostate bed within 1 month.
Secondary outcomes (1)
BMI
Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness. BMI can be used to screen for weight categories that may lead to health problems but it is not diagnostic of the body fatness or health of an individual.
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start22 Aug 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoyi Duan, Ph.D., Study chair, First Affiliate Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521894
- Sponsor's protocol ID
- 2019LunShenYiZiDiJ1Hao
- Other IDs
- XJTU1AF-CRF-2020-008
- Status last verified
- Jun 2023
- First submitted
- 17 Aug 2020
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo L, Zheng A, Chang R, Li Y, Gao J, Wang Z, Duan X. Evaluating the value of 18F-PSMA-1007 PET/CT in the detection and identification of prostate cancer using histopathology as the standard. Cancer Imaging. 2023 Nov 3;23(1):108. doi: 10.1186/s40644-023-00627-x.
PubMed 37924154
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of 18F-prostate-specific Membrane Antigen-1007 PET/CT in the Detection of Prostate Cancer
- ClinicalTrials.gov ID
- NCT04521894
- Acronym / sponsor ID
- 2019LunShenYiZiDiJ1Hao
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate-specific antigen, PET/CT, PSMA, Gleason Score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 22 Aug 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 21 Aug 2020 (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 most common type of malignant tumor and the third leading cause of cancer-associated mortality among men worldwide. The biological behaviors of PCa at different degrees of malignancy also largely differ, directly impacting disease outcomes and responses to treatment. Therefore, accurate risk stratification of PCa before treatment and the development of an individualized treatment regimen, play a vital role to improve the clinical outcome of patients. However, overdiagnosis and unnecessary biopsies, which are invasive examinations associated with higher costs and adverse effects. When the PSA is less than 20ng/mL, less than 1% of PCa patients have a positive bone scan, and routine bone scans are not recommended for asymptomatic or low-risk PCa patients. Interestingly, due to the variations among evaluators that often occur when defining the T stage, biopsies operate inaccuracy, also low-PSA level can also occur metastasis, there is a need for an objective and accurate imaging biomarker for the diagnosis of different grade PCa.
Prostate-specific membrane antigen (PSMA) is a type II transmembrane protein, which has higher expression in cancerous prostate cells than in normal prostate cells. Meanwhile, its expression level is positively correlated with the degree of malignancy, the tendency of metastasis, and the risk of early recurrence. In recent years, 18F-PSMA positron emission tomography/computerized tomography (PSMA PET/CT) has earned widespread attention as a novel imaging modality based on molecular-level analysis, rather than morphological or physiological analysis, to assist in PCa diagnosis and tumor burden evaluation.
Currently, Maximum Standardized Uptake Value (SUVmax) is the most commonly used semi-quantitative parameter in PET/CT, which is used to assess tumor burden of PCa, and thus can be used as an imaging biomarker to assess the degree of malignancy of prostate cancers. However, prior studies mainly focused on the correlation between patients' biochemical recurrence lesions and the PSA levels and Gleason score. There is a lack of research to explore the correlation among primary PCa burden, PSA levels, and the degree of prostate cancer malignancy. The aim of this project is to use 18F-PSMA PET/CT SUVmax to analyze the correlation among primary PCa imaging, and clinical indicators, and to evaluate the predictive value for PCa risk stratification, metastasis risk, and biochemical recurrence.
Detailed description
Prostate cancer (PCa) is the highest malignant male tumor and one of the leading causes of mortality among men worldwide. The biological behaviors of PCa malignancy are largely heterogeneous, directly impacting prognostic grouping and treatment options. In addition, assessments of the distant metastatic status for PCa patients have recently received increasing attention due to the heightening mortality rate. Therefore, the precise systemic staging of primary PCa risk stratification before treatment plays a crucial role in designing the management strategy for the individualized treatment option. According to both American Urological Association (AUA) and the European Association of Urology (EAU) guidelines, patients with total prostate-specific antigen (tPSA) > 20 ng/mL and/or Gleason Score ≥ 8 are high-risk, the probability of distant metastasis and mortality will increase significantly and may not suitable for active surveillance programs, radical prostatectomy or radiotherapy treatment. However, tPSA is organ-specific but not tumor-specific, the biological behaviors of prostate malignancy are largely heterogeneous, and the specificity of the ability of tPSA to reflect distant metastasis remains debatable. Using tPSA as the only indicator for risk stratification discrimination and distant metastases prediction may causing in large numbers of unnecessary prostate biopsies. Also, elderly patients with severe comorbidities or undergoing anticoagulation therapy may not be the optimal candidates for biopsies and may cause adverse effects and higher costs. In these cases, it is urgent to find objective and accurate imaging biomarkers for risk stratification classification with a noninvasive approach based on imaging analysis.
The prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein that is primarily expressed in prostatic tissues, and its expression is correlated with the degree of malignancy and further increases in metastatic. The ability of PSMA to easily penetrate tissues and diffuse with solid tumor lesions can reflect the statuses of metastasis. Prior studies show that PSMA PET/CT is superior to conventional imaging methods for lymph node metastatic detection and that the pre-treatment tPSA level and Gleason Score are associated with the PSMA uptake in primary PCa. Furthermore, the Maximum Standardized Uptake Value (SUVmax) is the most commonly used semi-quantitative parameter in PET/CT and prior studies have already been used to assess the degree of malignancy of PCa and predict extended pelvic lymph node metastases in intermediate to high-risk PCa patients by 68Ga-PSMA-11 or 68Ga-PSMA-617. 18F-PSMA-1007 is advantaged by its higher spatial resolution images and non-urinary excretion that reduces urinary clearance, this approach bears a great potential to facilitate the detection of primary PCa and metastatic lesions. However, to our knowledge, no prior studies have employed 18F-PSMA-1007 PET/CT to evaluate the diagnostic performance in risk stratification and distant metastases prediction in primary PCa.
The present study aims to retrospective investigated the role of 18F-PSMA-1007 PET/CT semi-quantitative parameters correlation among newly diagnosed PCa imaging, tPSA levels and Gleason Score, and to evaluate the prediction performance of 18F-PSMA-1007 PET/CT and clinicopathologic characteristics on PCa risk stratification and distant metastatic prediction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Primary PCa without metastases Group | – | Device: Positron emission tomography/computerized tomography (PET/CT)Participants who are suspected of prostate cancer due to elevated PSA or clinical symptoms but have not received any treatment and eventually confirmed prostate cancer after surgery or biopsies. |
| Primary PCa with metastases Group | – | Device: Positron emission tomography/computerized tomography (PET/CT)Participants who are suspected of prostate cancer due to elevated PSA or clinical symptoms but have not received any treatment and eventually confirmed prostate cancer after surgery or biopsies. And the 18F-PSMA-PET/CT scan confirmed metastases. |
| Oligometastatic PCa group | – | Device: Positron emission tomography/computerized tomography (PET/CT)"Oligometastatic"is a subgroup of metastatic patients with a limited number of secondary lesions (threshold ranging from 3 to 5) in one or few organs. |
| Biochemical recurrence Group | – | Device: Positron emission tomography/computerized tomography (PET/CT)Proven biochemical recurrence after radical therapy (PSA >0.2 ng/mL after radical prostatectomy, PSA ≥2 ng/mL above the nadir after external-beam radiotherapy) or persisting PSA after radical treatment with rising PSA values. |
| Control Group | – | Device: Positron emission tomography/computerized tomography (PET/CT)Prostate cancer benign prostatic hypertrophy or normal prostate. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate cancer, benign prostatic hyperplasia, and healthy volunteers who are pathologically confirmed in the First Affiliated Hospital of Xi'an Jiaotong University due to elevated PSA levels or clinical symptoms will include in this study, with complete clinical and pathological data, and complete PET/CT scan before receiving treatment.
Key inclusion criteria (4 listed)
- 1 age between 40 and 100 years old
- 2 PSA >0.4 ng/mL for primary PCa with biopsy proven or RP diagnosis of prostate cancer
- 3 PSA >0.2 ng/mL after RP, PSA ≥2 ng/mL above the nadir after EBRT) or persisting PSA after radical treatment with rising PSA values
- 4 complete clinical, pathological, imaging and biochemical information
Key exclusion criteria (2 listed)
- 1 lack of histological examinationproven diagnosis of PCa
- 2 18F-PSMA PET/CT being performed after pharmacotherapy since PSMA-targeted imaging can be disturbed by previous therapie
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 |
|---|---|---|
| Positron emission tomography/computerized tomography (PET/CT)1. Genetic factors and age: Epidemiological studies have shown that if an immediate family member (brother or father) suffers from prostate cancer, the risk of prostate cancer will be more than doubled. Age is a relatively strong risk factor for PCa. 2. Prostatitis: Prostatitis is related to PCa. Cancer is usually found in the tissues where inflammation is found. 3. Obesity: Research has found that obese patients have a low grade of PCa, but their risk of developing aggressive cancer is higher. 4. Infection: 5. Exercise: Most studies have found that exercise does not reduce the risk of prostate cancer, but some studies have shown that. 6. Daily diet: The corrective mechanism of diet in PCa is not very clear. 7. Drinking history: | Device | Biochemical recurrence Group, Control Group, Oligometastatic PCa group, Primary PCa with metastases Group, Primary PCa without metastases Group |
Primary outcome
SUVmax
Time frame: From the time the participants first go to the hospital without treatment and through study completion, an average of 1 year. If the patient undergoes radical prostatectomy, an additional scan will be added within 1 month after surgery
Maximum Standardized Uptake Value (SUVmax) is the most commonly used semi-quantitative parameter in PET/CT, which is used to assess tumor burden of PCa.
PSA
Time frame: Through study completion, an average of 6 months
Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood.
Gleason Score
Time frame: Baseline of the study by prostate cancer biopsies or after radical prostatectomy, and when there is a biochemical recurrence, an additional biopsies the prostate bed within 1 month.
The cells are graded on a scale of 1 to 5. Grade 1 cells resemble normal prostate tissue. Cells closest to 5 are considered "high-grade" and have mutated so much that they barely resemble normal cells.
1 secondary outcome
BMI
Time frame: Through study completion, an average of 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Derived from this study: PubMed 37924154Luo L, Zheng A, Chang R, Li Y, Gao J, Wang Z, Duan X. Evaluating the value of 18F-PSMA-1007 PET/CT in the detection and identification of prostate cancer using histopathology as the standard. Cancer Imaging. 2023 Nov 3;23(1):108. doi: 10.1186/s40644-023-00627-x.
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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.
Xiaoyi Duan, Ph.D. study chair
First Affiliate Hospital of Xi'an Jiaotong University
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 Prostatic Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 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 9 Jun 2023. 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 China. 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 Xiaoyi Duan, Ph.D. (0086-029-85324741, duanxy@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax (time frame: From the time the participants first go to the hospital without treatment and through study completion, an average of 1 year. If the patient undergoes radical prostatectomy, an additional scan will be added within 1 month after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04521894, which also lists 1 linked publication.
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 9 Jun 2023.