Clinical trial NCT04030338: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Prostate Neoplasm
Prostate Adenocarcinoma
Prostate Cancer Metastatic
Metastatic Prostate Cancer
Keywords: prostate cancer
Metastatic Prostate Cancer
PCWG3
18 F-DCFPyL
68 Ga-PSMA
19-170
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2019-07-23
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Measure predictive accuracy of the change in PSMA PET with respect to the time to biochemical progression
timeFrame: start of treatment to the first PSA level above 0.2 ng/ml, up to 100 months
measure: Measure predictive accuracy of the change in PSMA PET with respect to the time to metastasis
timeFrame: Time from the start of treatment to evidence of systemic disease on bone scan or CT/MRI, up to 100 months
measure: Measure predictive accuracy of the change in PSMA PET with respect to overall survival time.
timeFrame: Time from the start of treatment to date of death from any cause, assessed up to up to 100 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Heiko Schoder, MD
role: PRINCIPAL_INVESTIGATOR
References: