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The Application Value of 18F Prostate-specific Membrane Antigen Positron Emission Tomography/Computerized Tomography(18F-PSMA-PET/CT)in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04521894
Recruitment Status : Not yet recruiting
First Posted : August 21, 2020
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief 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. 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, such as infection and bleeding. The American Urological Association (AUA) and the European Association of Urology (EAU) adopted that 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 indexes SUVmax to analyze the correlation among primary PCa imaging, GS, and PSA levels, and to evaluate the predictive value of this method for prostate cancer risk stratification, metastasis risk, and biochemical recurrence.


Condition or disease Intervention/treatment
Prostatic Neoplasms Device: Positron emission tomography/computerized tomography (PET/CT)

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Performance of 18F-PSMA-PET/CT in the Detection of Prostate Cancer
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Device: 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:

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.
Device: 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:

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.
Device: 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:

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.
Device: 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:

Control Group
Prostate cancer benign prostatic hypertrophy or normal prostate.
Device: 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:




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. BMI [ Time Frame: Through study completion, an average of 6 months. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04521894


Contacts
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Contact: Xiaoyi Duan, Ph.D. 0086-029-85324741 duanxy@xjtu.edu.cn
Contact: Zhuonan Wang, Ph.D. 0086-029-85324741 zhuonanwang@xjtufh.edu.cn

Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Study Chair: Xiaoyi Duan, Ph.D. First Affiliate Hospital of Xi'an Jiaotong University
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT04521894    
Other Study ID Numbers: 2019LunShenYiZiDiJ1Hao
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Prostate-specific antigen
PET/CT
PSMA
Gleason Score
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases