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| Name | Class |
|---|---|
| Grand Pharmaceutical (China) Co., Ltd. | OTHER |
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This is a prospective, open-label, single-arm, multicenter bridging study in Chinese patients with prostate cancer. This multicenter study is planned to be conducted in patients with biochemical recurrence (BCR) of elevated PSA after radical prostatectomy or radical radiotherapy. This study investigates how well 68Ga-PSMA-11 PET/CT works in detecting BCR prostate cancer in Chinese patient. 68Ga-PSMA-11, developed by Telix, is a new molecular entity tracer with the trade name Illuccix®, which is approved by FDA for the examination of: 1) patients with suspected metastatic PC who are scheduled for initial treatment; 2) patients with biochemical recurrence of elevated PSA levels after initial radical radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (68Ga-PSMA-11) | Experimental | 111 ~ 259 MBq 68Ga-PSMA-11 will be administered intravenously to participants over 3- 5 minutes. After 50-100 minutes post 68Ga-PSMA-11 injection, participants will be scanned (PET/CT or PET/MRI) from the mid-thigh to the apex of the skull. Participants will be placed in a supine position with the arms raised overhead. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-PSMA-11 | Drug | A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value (PPV) of 68Ga-PSMA-11 PET/CT or PET/MRI for detection of tumour on a patient level confirmed by histopathology/biopsy, clinical (PSA) and conventional imaging follow-up. | The PPV [PPV (%) = TP* /(TP + FP**)] will be determined by the combination of histopathology/biopsy and conventional imaging and/or PSA follow-up results as the true criteria (composite criteria) and the results observed by 68Ga-PSMA-11 PET (positive/negative). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Safety will be reported descriptively as rates of patient reported adverse events. Additionally, adverse events will be characterized and quantified by Common Terminology Criteria for Adverse Events | 3 days |
| Clinical management in biochemical recurrence patients. |
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Inclusion Criteria:
Are able to understand and provide written informed consent document.
Are Chinese males aged ≥ 18 years.
Have histopathologically confirmed prostate adenocarcinoma and have undergone radical prostatectomy and/or radical radiotherapy and experienced biochemical recurrence (PSA should be measured within 30 days of screening).
Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent).
Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.
Are willing and able to comply with scheduled
Exclusion Criteria:
Prostate cancer is limited to males only
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | China |
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This study aims to recruit 110 prostate cancer patients with elevated PSA (BCR) after radical prostatectomy or radical radiotherapy
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| PET/CT or PET/MRI | Other | PET/CT or PET/MRI will be acquired no sooner than 50 minutes post injection and not later than 100 minutes post injection with 68Ga-PSMA-11 |
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The impact of 68Ga-PSMA-11 PET/CT or PET/MRI on clinical management in biochemical recurrence patients will be assessed through the completion of Medical Management Questionnaires completed prior to and after 68Ga-PSMA-11 PET/CT or PET/MRI. |
| 3 days |
| Xiangya Hospital Central South University | Recruiting | Changsha | China |
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| Nanfang Hospital Southern Medical University | Recruiting | Guangzhou | China |
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| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| West China Hospital of Sichuan University | Recruiting | Sichuan | China |
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| Wuhan Union Hospital | Recruiting | Wuhan | China |
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| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | China |
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| Affiliated Hosptial of Jiangnan University | Recruiting | Wuxi | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
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