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出境医 / 临床实验 / Prostate-Specific Membrane Antigen (PSMA) PET Scans in People Prostate Cancer

Prostate-Specific Membrane Antigen (PSMA) PET Scans in People Prostate Cancer

Study Description
Brief Summary:
The purpose of this study is to determine if Prostate-Specific Membrane Antigen (PSMA) positron emission tomography (PET) scans used in this study accurate and better at imaging participants' prostate cancer than the usual methods.

Condition or disease Intervention/treatment
Prostate Cancer Prostate Neoplasm Prostate Adenocarcinoma Prostate Cancer Metastatic Metastatic Prostate Cancer Drug: 18F-DCFPyL-iPSMA Drug: 68Ga-HBED-iPSMA Diagnostic Test: PET/CT scan

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serial PSMA PET Imaging in the Assessment of Treatment Response in Patients With Progressive Prostate Cancer
Actual Study Start Date : July 19, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Prostate cancer
Participants with histologically confirmed prostate cancer, that is either newly diagnosed OR progressive as defined by standard PCWG3 criteria. Patients w ill remain on study until 30 days after their last PSMA imaging timepoint required by their companion therapeutic protocol.
Drug: 18F-DCFPyL-iPSMA
Participants will be injected intravenously with a bolus of 7-10 mCi of 18F-DCFPyL.

Drug: 68Ga-HBED-iPSMA
Participants will be injected intravenously with a bolus of 3-8 mCi of 68Ga-HBED-iPSMA

Diagnostic Test: PET/CT scan
The baseline PSMA PET scan may be performed externally or at MSKCC, but all follow-up imaging must be performed at MSKCC. Approximately 60-90 minutes after intravenous injection of radiotracer, patients will be scanned from the mid-skull to the mid-thigh. Imaging will start with a low-dose CT for attenuation correction, followed by a PET scan. Upon completion of imaging and at the discretion of the investigator, the patient may be asked to void and get back in the scanner for 1 additional image of the pelvis.This additional image allows investigator's to see an unobstructed view of the prostate/prostate bed

Outcome Measures
Primary Outcome Measures :
  1. Measure predictive accuracy of the change in PSMA PET with respect to the time to biochemical progression [ Time Frame: start of treatment to the first PSA level above 0.2 ng/ml, up to 100 months ]
  2. Measure predictive accuracy of the change in PSMA PET with respect to the time to metastasis [ Time Frame: Time from the start of treatment to evidence of systemic disease on bone scan or CT/MRI, up to 100 months ]
  3. Measure predictive accuracy of the change in PSMA PET with respect to overall survival time. [ Time Frame: Time from the start of treatment to date of death from any cause, assessed up to up to 100 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSK) in the Department of Medical Oncology, Radiology, Radiation Oncology or Surgery. Investigators will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study.
Criteria

Inclusion Criteria:

  • Patients with histologically confirmed prostate cancer, that is either: newly diagnosed OR progressive as defined by standard PCWG3 criteria. note that metastatic disease is defined by either bone scintigraphy or by CT or MRI, or a combination of these tests, but not exclusively by molecular imaging criteria.

Patients with newly diagnosed localized or metastatic prostate cancer are eligible, provided standard imaging (either bone scintigraphy, CT or MRI) demonstrates evidence of radiographic disease

Patient with progressive disease that is non-metastatic are eligible by biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart

Patients with progressive disease that is metastatic are eligible either by biochemical progression or radiographic progression or both

Patients are permitted to have had up to 2 months of prior hormonal therapy before entering this trial (and many therapeutic trials) and therefore, their progression criteria would apply to their pre-treatment imaging and PSA parameters

  • Karnofsky performance status of >/= 50 (or ECOG/WHO equivalent)
  • Male (or transgender female) > 18 years of age
  • Patient must be able to understand and willing to sign a written informed consent document
  • Patient is anticipating starting a therapeutic strategy following imaging

Exclusion Criteria:

  • Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and non-invasive bladder cancer
  • Unable to lie flat, still or tolerate a PET scan
Contacts and Locations

Contacts
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Contact: Heiko Schoder, MD 212-639-2079 schoderh@mskcc.org
Contact: Deaglan McHugh, MD 631-212-6320 mchughd@mskcc.org

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Heiko Schöder, MD    212-639-2079      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Heiko Schoder, MD    212-639-2079      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Heiko Schoder, MD    212-639-2079      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Heiko Schöder, MD    212-639-2079      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Heiko Schoder, MD    212-639-2079      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Heiko Schoder, MD    212-639-2079      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Heiko Schoder, MD    212-639-2079      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Progenics Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Heiko Schoder, MD Memorial Sloan Kettering Cancer Center
Tracking Information
First Submitted Date July 19, 2019
First Posted Date July 23, 2019
Last Update Posted Date November 19, 2020
Actual Study Start Date July 19, 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 22, 2019)
  • Measure predictive accuracy of the change in PSMA PET with respect to the time to biochemical progression [ Time Frame: start of treatment to the first PSA level above 0.2 ng/ml, up to 100 months ]
  • Measure predictive accuracy of the change in PSMA PET with respect to the time to metastasis [ Time Frame: Time from the start of treatment to evidence of systemic disease on bone scan or CT/MRI, up to 100 months ]
  • Measure predictive accuracy of the change in PSMA PET with respect to overall survival time. [ Time Frame: Time from the start of treatment to date of death from any cause, assessed up to up to 100 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prostate-Specific Membrane Antigen (PSMA) PET Scans in People Prostate Cancer
Official Title Serial PSMA PET Imaging in the Assessment of Treatment Response in Patients With Progressive Prostate Cancer
Brief Summary The purpose of this study is to determine if Prostate-Specific Membrane Antigen (PSMA) positron emission tomography (PET) scans used in this study accurate and better at imaging participants' prostate cancer than the usual methods.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering Cancer Center (MSK) in the Department of Medical Oncology, Radiology, Radiation Oncology or Surgery. Investigators will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study.
Condition
  • Prostate Cancer
  • Prostate Neoplasm
  • Prostate Adenocarcinoma
  • Prostate Cancer Metastatic
  • Metastatic Prostate Cancer
Intervention
  • Drug: 18F-DCFPyL-iPSMA
    Participants will be injected intravenously with a bolus of 7-10 mCi of 18F-DCFPyL.
  • Drug: 68Ga-HBED-iPSMA
    Participants will be injected intravenously with a bolus of 3-8 mCi of 68Ga-HBED-iPSMA
  • Diagnostic Test: PET/CT scan
    The baseline PSMA PET scan may be performed externally or at MSKCC, but all follow-up imaging must be performed at MSKCC. Approximately 60-90 minutes after intravenous injection of radiotracer, patients will be scanned from the mid-skull to the mid-thigh. Imaging will start with a low-dose CT for attenuation correction, followed by a PET scan. Upon completion of imaging and at the discretion of the investigator, the patient may be asked to void and get back in the scanner for 1 additional image of the pelvis.This additional image allows investigator's to see an unobstructed view of the prostate/prostate bed
Study Groups/Cohorts Prostate cancer
Participants with histologically confirmed prostate cancer, that is either newly diagnosed OR progressive as defined by standard PCWG3 criteria. Patients w ill remain on study until 30 days after their last PSMA imaging timepoint required by their companion therapeutic protocol.
Interventions:
  • Drug: 18F-DCFPyL-iPSMA
  • Drug: 68Ga-HBED-iPSMA
  • Diagnostic Test: PET/CT scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 22, 2019)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with histologically confirmed prostate cancer, that is either: newly diagnosed OR progressive as defined by standard PCWG3 criteria. note that metastatic disease is defined by either bone scintigraphy or by CT or MRI, or a combination of these tests, but not exclusively by molecular imaging criteria.

Patients with newly diagnosed localized or metastatic prostate cancer are eligible, provided standard imaging (either bone scintigraphy, CT or MRI) demonstrates evidence of radiographic disease

Patient with progressive disease that is non-metastatic are eligible by biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart

Patients with progressive disease that is metastatic are eligible either by biochemical progression or radiographic progression or both

Patients are permitted to have had up to 2 months of prior hormonal therapy before entering this trial (and many therapeutic trials) and therefore, their progression criteria would apply to their pre-treatment imaging and PSA parameters

  • Karnofsky performance status of >/= 50 (or ECOG/WHO equivalent)
  • Male (or transgender female) > 18 years of age
  • Patient must be able to understand and willing to sign a written informed consent document
  • Patient is anticipating starting a therapeutic strategy following imaging

Exclusion Criteria:

  • Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and non-invasive bladder cancer
  • Unable to lie flat, still or tolerate a PET scan
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Heiko Schoder, MD 212-639-2079 schoderh@mskcc.org
Contact: Deaglan McHugh, MD 631-212-6320 mchughd@mskcc.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04030338
Other Study ID Numbers 19-170
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Progenics Pharmaceuticals, Inc.
Investigators
Principal Investigator: Heiko Schoder, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date November 2020

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