| 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 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 |
| 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
|
| 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 |
Inclusion 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
Exclusion Criteria:
| Contact: Heiko Schoder, MD | 212-639-2079 | schoderh@mskcc.org | |
| Contact: Deaglan McHugh, MD | 631-212-6320 | mchughd@mskcc.org |
| 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 | |
| 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 |
|
||||||||
| 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 |
|
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| Intervention |
|
||||||||
| 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:
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
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 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
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | Memorial Sloan Kettering Cancer Center | ||||||||
| Study Sponsor | Memorial Sloan Kettering Cancer Center | ||||||||
| Collaborators | Progenics Pharmaceuticals, Inc. | ||||||||
| Investigators |
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| PRS Account | Memorial Sloan Kettering Cancer Center | ||||||||
| Verification Date | November 2020 | ||||||||