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Evaluation of the Metastasis and Recurrence of Prostate Cancer

Evaluation of the Metastasis and Recurrence of Prostate Cancer With 18F-PSMA PET/CT

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03507595
Enrollment
400
Registered
2018-04-25
Start date
2017-09-01
Completion date
2019-12-31
Last updated
2018-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer (Diagnosis), Prostate Cancer Metastatic, Prostate Cancer Recurrent, Prostate Cancer Stage

Keywords

prostate specific membrane antigen(PMSA), prostate cancer, PET/CT

Brief summary

This study aims to use the new molecular probe 18F-PSMA for the diagnosis,staging ,recurrence monitoring and evaluation of the prostate cancer.By compared with the conventional imaging methods (whole body bone scintigraphy and MRI) and molecular imaging methods (11C-choline PET/CT),we hope to find the advantages of 18F-PSMA PET/CT in the diagnosis and metastases of prostate cancer, and lay the foundation for the further clinical transformation.

Detailed description

This study aims to use the new molecular probe 18F-PSMA for the diagnosis,staging ,recurrence monitoring and evaluation of the prostate cancer.By compared with the conventional imaging methods (whole body bone scintigraphy and MRI) and molecular imaging methods (11C-choline PET/CT),we hope to find the advantages of 18F-PSMA PET/CT in the diagnosis and metastases of prostate cancer, and lay the foundation for the further clinical transformation.And make some comparison with those 3 methods.

Interventions

None listed

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion criteria

1. Patients with initial diagnosis of prostate cancer; 1)T2 stage: PSA\>20ng/ml, Gleason Score \>= 8; 2)T3 or T4 stage; 3)The imaging examination was negative or localized metastasis of the pelvic lymph node, but there was no distant metastasis of lymph nodes or bone and internal organs other than the pelvic cavity. 2. Patients with biochemical recurrent prostate cancer; 1)After the RRP surgery, the serum PSA was over 0.2 ng/ml in two consecutive sera; 2)After the radiotherapy: the lowest PSA is up to 2 ng/ml. 3. Patients with CRPC. 1)The serum testosterone is in the castration level (\< 50 ng/dL or \< 1.7 nmol/L); 2)The PSA is elevated 3 times in a row, the base value is increased by more than 50%, and the PSA \> 2ng/mL(the interval is one week); 3)The continuation of the anti-androgen drugs, flunamine was stopped for at least 4 weeks, and biglumide was suspended for at least 6 weeks; 4)Despite the continued standard androgen deprivation therapy, the PSA is still progressing.

Exclusion criteria

1. Patients who are unwilling to participate in the study or unwilling to sign the informed consent forms; 2. Patients who are critically ill, suffering from mental illness and cannot cooperate with the examination; 3. There are electronic implants, such as pacemakers and insulin pumps in the body, and magnetic metal foreign objects in the spot.

Design outcomes

Primary

MeasureTime frameDescription
18F-PSMA PET/CT imaging4 hoursThe outcome of 18F-PSMA PET/CT imaging.

Secondary

MeasureTime frameDescription
Bone scan imaging6 hoursThe outcome of bone scan imaging.
MRI imaging4 hoursThe outcome of MRI imaging.

Countries

China

Contacts

Primary ContactHui Wang, MD
wanghuishanghai@hotmail.com+86-021-25076980
Backup ContactJun Qi, MD
qijun@xinhuamed.com.cn+86-021-25078080

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026