Evaluation of the Metastasis and Recurrence of Prostate Cancer

NCT03507595 | Unknown

• 1 other identifier: XH-17-020
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 18F-PSMA PET/CT imaging

  The outcome of 18F-PSMA PET/CT imaging.

  4 hours

Secondary Outcomes (2)

• Bone scan imaging

  6 hours

• MRI imaging

  4 hours

Study Arms (3)

Patients with initial diagnosis of PCa

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.

Patients with biochemical recurrent PCa

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.

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.

Eligibility Criteria

• Gender Eligibility Details: Aged male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Patients with initial diagnosis of prostate cancer; * Patients with biochemical recurrent prostate cancer; * Patients with CRPC.

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hongliang Fu, MD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Wang, MD

CONTACT

+86-021-25076980; wanghuishanghai@hotmail.com

Jun Qi, MD

CONTACT

+86-021-25078080; qijun@xinhuamed.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 25, 2018
• Study Start: September 1, 2017
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 25, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)