Clinical trial NCT03507595: Evaluation of the Metastasis and Recurrence of Prostate Cancer
Official title: Evaluation of the Metastasis and Recurrence of Prostate Cancer With 18F-PSMA PET/CT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer (Diagnosis)
Prostate Cancer Metastatic
Prostate Cancer Recurrent
Prostate Cancer Stage
Keywords: prostate specific membrane antigen(PMSA)
prostate cancer
PET/CT
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 400
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Patients with initial diagnosis of prostate cancer;
* Patients with biochemical recurrent prostate cancer;
* Patients with CRPC.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 18F-PSMA PET/CT imaging
timeFrame: 4 hours
Secondary outcomes:
measure: Bone scan imaging
timeFrame: 6 hours
measure: MRI imaging
timeFrame: 4 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Hongliang Fu, MD
role: PRINCIPAL_INVESTIGATOR
References: