Serial PSMA PET Scans for the Imaging of Newly Diagnosed, Progressive, or Metastatic Prostate Cancer

Status: closed to accrual

This phase II/III trial studies how well serial PSMA PET scans work in imaging patients with prostate cancer that is newly diagnosed, growing, spreading, or getting worse (progressive), or has spread to other places in the body (metastatic). PSMA PET scans use radiation to make images of tumors. Serial PSMA PET scans may work better at showing the PSMA protein, which is located on many prostate cancer cells, and in assessing treatment response in patients with prostate cancer compared to the usual imaging methods.

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 * Patients 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 castration resistant prostate carcinoma (CRPC)
Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [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 OBJECTIVE:

I. To evaluate the predictive accuracy of the change in prostate-specific membrane antigen (PSMA) positron emission tomography (PET) with respect to the time to biochemical progression (as defined by Prostate Cancer Working Group [PCWG] 3), time to metastasis, and survival time.

SECONDARY OBJECTIVES:

I. To evaluate the predictive accuracy of the change in standard imaging modalities (computed tomography [CT], magnetic resonance imaging [MRI], bone scan) with respect to:

Ia. Time to biochemical (prostate specific antigen [PSA]) progression.

Ib. Time to metastasis.

Ic. Overall survival.

II. To estimate the association between the change in PSMA PET parameters and:

IIa. Change in CT, MRI and bone scan measures.

IIb. Biochemical (PSA) response to treatment.

III. Safety of repeated gallium Ga 68-labeled PSMA-11 (68Ga PSMA) or fluorine F 18 DCFPyL (18FDCFPyL) administration as categorized by Common Terminology Criteria for Adverse Events (CTCAE).

OUTLINE:

Within 6 weeks before beginning treatment for prostate cancer, patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) or fluorine F 18 DCFPyL IV. After 60-90 minutes, patients undergo PET/CT scan over 30-40 minutes. PSMA PET/CT scans repeat 4 weeks after starting treatment and at the end of treatment in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection during screening and follow-up.

Upon completion of study intervention, patients are followed up to 30 days.

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Serial PSMA PET Scans for the Imaging of Newly Diagnosed, Progressive, or Metastatic Prostate Cancer

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Trial Objectives and Outline

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