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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04030338
Collaborator
Progenics Pharmaceuticals, Inc. (Industry)
600
Enrollment
7
Locations
35.4
Anticipated Duration (Months)
85.7
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

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.

Study Design

Study Type:
Observational
Anticipated 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 :
Jul 19, 2019
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

ArmIntervention/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 [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 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 from the start of treatment to date of death from any cause, assessed up to up to 100 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1Memoral Sloan Kettering Basking RidgeBasking RidgeNew JerseyUnited States07920
2Memoral Sloan Kettering MonmouthMiddletownNew JerseyUnited States07748
3Memorial Sloan Kettering BergenMontvaleNew JerseyUnited States07645
4Memorial Sloan Kettering CommackCommackNew YorkUnited States11725
5Memorial Sloan Kettering WestchesterHarrisonNew YorkUnited States10604
6Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10021
7Memorial Sloan Kettering NassauUniondaleNew YorkUnited States11553

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center
  • Progenics Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Heiko Schoder, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT04030338
Other Study ID Numbers:
  • 19-170
First Posted:
Jul 23, 2019
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021