Serial PSMA PET Imaging in the Assessment of Treatment Response in Patients With Progressive Prostate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- 18F-DCFPyL-iPSMA
- Conditions
- Prostate Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 58
- Locations
- 7
- Primary Endpoint
- Measure predictive accuracy of the change in PSMA PET with respect to the time to biochemical progression
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
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 Note: This criterion pertains to patients with newly diagnosed, untreated disease. This criterion does not apply to those who were already on therapy for metastatic CRPC.
- •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
Arms & Interventions
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.
Intervention: 18F-DCFPyL-iPSMA
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.
Intervention: 68Ga-HBED-iPSMA
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.
Intervention: PET/CT scan
Outcomes
Primary Outcomes
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 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
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