Prostate Cancer Clinical Trial
Official title:
Clinical Applications of Integrated PET/MR and PET/CT in the Diagnosis and Treatment of Prostate Cancer.
NCT number | NCT06355843 |
Other study ID # | SXY |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | April 28, 2022 |
Est. completion date | March 31, 2027 |
Verified date | September 2023 |
Source | The First Affiliated Hospital of Anhui Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study type: observational study (prospective study) is to study prostate cancer occurrence and recurrence, to specifically identify and localize tumor foci at the molecular level at an early stage, to evaluate the prognosis of patients, and to accurately stage not only intermediate- and high-risk prostate cancer patients with a primary diagnosis, but also detect recurrent foci in patients with biochemical recurrence, to restage those who have developed metastases, to assess tumor load, and to ultimately assist in determining the personalized treatment plans. The main question it aims to answer is whether 68Ga-PSMA PET/CT (PET/MR) examination is beneficial for assessing the - Accurate staging of patients with intermediate- and high-risk prostate cancer at first diagnosis; - Detecting recurrent lesions in patients with recurrent tumors for re-staging; - Assessment of tumor load; - Assessment of patient prognosis. Participants will sign an informed consent form, undergo 68Ga-PSMA PET/CT (PET/MR) before surgery or biopsy, and have regular follow-up after obtaining pathological results of surgical resection or puncture biopsy, 6 weeks after surgery or biopsy, and then every 3 months; the follow-up will include: blood PSA, whole-body bone imaging, etc.
Status | Suspended |
Enrollment | 50 |
Est. completion date | March 31, 2027 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 18 years = 75 years of age; - Patients with clinical suspicion of prostate cancer; - No recent invasive tests or treatments were performed; - Blood count: leukocytes>4×109/L, neutrophils>2×109/L, haemoglobin>90g/L, platelets>100×109/L; - Cardiac function: left ventricular ejection fraction >50%; - Pulmonary function tests: FEV1 =1.2L, FEV1% =50% and DLCO =50%; - Liver function: total bilirubin <1.5 times upper limit of normal (ULN); AST and ALT <1.5 times ULN; - Renal function: serum creatinine = 1.5 times ULN, or glomerular filtration rate > 60 ml/min; - Participants agreed to participate in this clinical trial and signed an informed consent form; - Good compliance and commitment to follow the study procedures and to cooperate in the implementation of the full study; - No birth plans for six months. Exclusion Criteria: - Those with severe psychiatric symptoms, or those who are too confused to cooperate with the examination; - Those with poor compliance. |
Country | Name | City | State |
---|---|---|---|
China | First affiliated hospital of anhui university | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Anhui Medical University | National Natural Science Foundation of China |
China,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measuring the value of 68Ga-PSMA PET/MRI in the diagnosis and staging of primary prostate cancer and comparing it with mp-MRI and PET/CT | 68Ga-PSMA-11 PET/MRI and multiparametric MRI images of participants with suspected prostate cancer were collected and compared with 68Ga-PSMA-11 PET/MRI, 68Ga-PSMA-11 PET and multiparametric MRI for the diagnosis of prostate cancer, using histopathological findings as the "gold standard". Accuracy, sensitivity, specificity, positive and negative predictive values were calculated. The diagnostic efficacy of the three was analyzed by plotting the working characteristic curves of the subjects. | up to 28 months | |
Primary | Exploring whether 68Ga-PSMA PET/MRI can be used as a method for diagnostic efficacy | 68Ga-PSMA-11 PET/MRI images of prostate cancer patients were collected, and the histopathological findings were used as the "gold standard". The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of 68Ga-PSMA-11 PET/MRI for diagnosing T, N, and M stages of prostate cancer were calculated. The working characteristic curves of the subjects were plotted and their diagnostic efficacy was calculated by the area under the curve. | up to 32 months |
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