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Evaluation of the Metastasis and Recurrence of Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03507595
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease
Prostate Cancer (Diagnosis) Prostate Cancer Metastatic Prostate Cancer Recurrent Prostate Cancer Stage

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.

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Metastasis and Recurrence of Prostate Cancer With 18F-PSMA PET/CT
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 18F-PSMA PET/CT imaging [ Time Frame: 4 hours ]
    The outcome of 18F-PSMA PET/CT imaging.


Secondary Outcome Measures :
  1. Bone scan imaging [ Time Frame: 6 hours ]
    The outcome of bone scan imaging.

  2. MRI imaging [ Time Frame: 4 hours ]
    The outcome of MRI imaging.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Aged male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Patients with initial diagnosis of prostate cancer;
  • Patients with biochemical recurrent prostate cancer;
  • Patients with CRPC.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507595


Contacts
Contact: Hui Wang, MD +86-021-25076980 wanghuishanghai@hotmail.com
Contact: Jun Qi, MD +86-021-25078080 qijun@xinhuamed.com.cn

Locations
China, Shanghai
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200092
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Hongliang Fu, MD Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  Study Documents (Full-Text)

Documents provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Informed Consent Form  [PDF] September 1, 2017


Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03507595     History of Changes
Other Study ID Numbers: XH-17-020
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
prostate specific membrane antigen(PMSA)
prostate cancer
PET/CT

Additional relevant MeSH terms:
Prostatic Neoplasms
Recurrence
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes