68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients
NCT ID: NCT05847348
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
110 participants
INTERVENTIONAL
2023-07-19
2026-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Treatment (68Ga-PSMA-11)
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.
68Ga-PSMA-11
A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes
PET/CT or PET/MRI
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
Interventions
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68Ga-PSMA-11
A single dose of 111 - 259 MBq administered intravenously over 3 -5 minutes
PET/CT or PET/MRI
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Are Chinese males aged ≥ 18 years.
3. 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).
1. Post radical prostatectomy (RP) PSA ≥0.2 ng/mL measured 6 weeks after RP
2. Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA;
4. Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent).
5. Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.
6. Are willing and able to comply with scheduled
Exclusion Criteria
2. Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.
3. Are participating or plan to participate in any drug or device clinical study during the study period.
4. Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.
5. Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.
6. Have prior history of salivary gland disease or Paget's disease.
7. Have a history of fracture and anemia within the last year.
8. Have abnormalities in physical examination, ECG, and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance.
9. Is deemed not suitable for participating in this trial in the opinion of the investigator.
18 Years
MALE
No
Sponsors
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Grand Pharmaceutical (China) Co., Ltd.
OTHER
Telix Pharmaceuticals (Innovations) Pty Limited
INDUSTRY
Responsible Party
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Locations
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Peking University First Hospital
Beijing, , China
Xiangya Hospital Central South University
Changsha, , China
Nanfang Hospital Southern Medical University
Guangzhou, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
West China Hospital of Sichuan University
Sichuan, , China
Wuhan Union Hospital
Wuhan, , China
Zhongnan Hospital of Wuhan University
Wuhan, , China
Affiliated Hosptial of Jiangnan University
Wuxi, , China
Countries
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Facility Contacts
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Other Identifiers
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68Ga-PSMA-11-001
Identifier Type: -
Identifier Source: org_study_id
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