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Active, Not Recruiting

NCT Number: NCT04030338

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-DCFPyL-iPSMA

Drug

Participants will be injected intravenously with a bolus of 7-10 mCi of 18F-DCFPyL.

68Ga-HBED-iPSMA

Drug

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

PET/CT scan

Diagnostic Test

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Progenics Pharmaceuticals, Inc.

Registry information

Official study title

Serial PSMA PET Imaging in the Assessment of Treatment Response in Patients With Progressive Prostate Cancer

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2019
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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