Fluorine F 18 DCFPy PET/CT in Imaging Patients with Metastatic or Locally Advanced Prostate Cancer

Status: complete

This phase I trial studies the side effects of fluorine F 18 DCFPy positron emission tomography (PET)/computed tomography (CT) and how well it works in imaging patients with prostate cancer that has spread to other parts of the body or to nearby tissue or lymph nodes. Fluorine F18 DCFPy is a radioactive material injected into the blood that is taken up by prostate cancer cells. PET is a procedure that takes detailed pictures of areas inside the body where the material is taken up. CT scans use x-rays and a computer to produce a 3-dimensional image of the body. Combining fluorine F 18 DCFPy PET and CT scans may help doctors better identify the location of prostate cancer and how far it has spread.

Inclusion Criteria

INCLUSION CRITERIA (INITIAL 10 PATIENTS WITH METASTATIC PROSTATE CANCER)
Histological confirmation of prostate cancer
Can be on androgen deprivation therapy if dose is stable for >= 1 week
Platelet count > 50,000/mm^3
Neutrophil count > 1,000/mm^3
Patient is judged by the investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures
INCLUSION CRITERIA (NEXT 60 PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER): Histological confirmation of prostate cancer
INCLUSION CRITERIA (NEXT 60 PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER): Pathologically confirmed clinically localized intermediate risk or higher prostate cancer (clinical stage >= T2b or Gleason sum >= 7 or PSA >= 10 ng/mL)
INCLUSION CRITERIA (NEXT 60 PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER): Scheduled to undergo surgical resection with radical prostatectomy and lymphadenectomy
INCLUSION CRITERIA (NEXT 60 PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER): Patient is judged by the investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
INCLUSION CRITERIA (NEXT 60 PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER): Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures

Exclusion Criteria

EXCLUSION CRITERIA (ALL PATIENTS)
Karnofsky performance status of < 60
Inadequate venous access (a single antecubital or equivalent venous access sites are required for study drug injection)
Patient received a permanent prostate brachytherapy implant within the last 3 months (for palladium [Pd]-103 implants) or 12 months (for iodine [I]-125 implants)
Administered a radioisotope within 5 physical half-lives prior to study enrollment
Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration (washout is one half-life of the drug or 2 weeks, whichever is longest)
Prior history of any other malignancy within 3 years, other than skin basal cell carcinoma

PRIMARY OBJECTIVES:

I. To determine safety, biodistribution and radiation dosimetry of fluorine F 18 DCFPy (18F-DCFPyL) in patients with metastatic prostate cancer (initial 10 patients only).

SECONDARY OBJECTIVES:

I. Estimate the tumor to normal organ (signal to noise ratio) uptake of the imaging tracer at four time points: approximately 10, 25, 55 and 120 minutes post injection of less than or equal to 9 mCi of 18F-DCFPyL (initial 10 patients only).

II. At the patient level, estimate the probability that 18F-DCFPyL prostate-specific membrane antigen (PSMA)-based PET will detect an area of local, nodal and/or distant prostate cancer spread.

III. Accounting for intra-cluster correlation (the patient is considered the cluster), estimate the proportion of index lesions found on conventional imaging modalities (CIM) or bone scintigraphy that are 18F-DCFPyL PET positive and give the 95% confidence interval. Estimate the intra-cluster correlation.

IV. Accounting for intra-cluster correlation, estimate the mean maximum standardized uptake value (SUVmax) and average standardized uptake value (SUVmean) of index lesions and give the 95% confidence interval. Estimate the intra-cluster correlation.

V. Estimate the median and average number of new sites per patient detected with 18F-DCFPyL PET.

VI. Estimate the inter-observer agreement between two independent readers for the visual assessment of uptake.

VII. Adjusting for intra-cluster correlation, explore the association between the levels of serum prostate-specific antigen (PSA) (high vs. low) and the frequency of areas of tumor spread identified with 18F-DCFPyL PET. Similarly, explore the association between the levels of serum PSA and SUV parameters.

VIII. Correlate PET/CT findings with postoperative PSA levels and time to biochemical recurrence (defined as PSA > 0.2 ng/dL).

OUTLINE:

Patients receive fluorine F 18 DCFPyL intravenously (IV) and then undergo 3-dimensional (3D) PET/CT at 90 minutes and low dose x-ray CT followed by four PET scans at 120 minutes post-injection (metastatic prostate cancer patients) or undergo 3D PET/CT at 60 minutes post-injection (National Comprehensive Cancer Network [NCCN] high or very high-risk prostate cancer patients).

After completion of study, patients are followed up at 1-2 days and then every 3 to 6 months for 2 years (clinically localized intermediate risk or higher) or at 30 days (metastatic prostate cancer patients).

Have a question?
We're here to help

Chat with us: LiveHelp
Call us: 1-800-4-CANCER
(1-800-422-6237)

Which trials are right for you?

Use the checklist in our guide to gather the information you’ll need.

Fluorine F 18 DCFPy PET/CT in Imaging Patients with Metastatic or Locally Advanced Prostate Cancer

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

Have a question?We're here to help

Which trials are right for you?

Have a question?
We're here to help