F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate Cancer

NCT ID: NCT03501940

Last Updated: 2022-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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This study provides fluorine F 18 DCFPyL positron emission tomography/computed tomography (PET/CT) to participants with prostate cancer that has come back. Diagnostic procedures, such as fluorine F 18 DCFPyL PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.

Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate fluorine F 18 DCFPyL (18F-DCFPyL) PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated prostate-specific antigen (PSA).

OUTLINE:

Participants receive fluorine F 18 DCFPyL intravenously (IV). After 60-120 minutes, participants undergo whole body PET/CT. Immediately after the first scan, participants may undergo a second PET/CT without receiving fluorine F 18 DCFPyL.

After completion of study, participants are followed up at 24-72 hours.

Conditions

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Prostate Adenocarcinoma PSA Level Greater Than 0.2 PSA Level Greater Than or Equal to Two PSA Progression Recurrent Prostate Carcinoma

Interventions

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Computed Tomography

Undergo 18F-DCFPyL PET/CT

Intervention Type PROCEDURE

Fluorine F 18 DCFPyL

Given IV

Intervention Type RADIATION

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Positron Emission Tomography

Undergo 18F-DCFPyL PET/CT

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography computerized tomography CT CT SCAN tomography 18F-DCFPyL Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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Inclusion Criteria

* Biopsy proven prostate adenocarcinoma
* Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)

* Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation

* PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy
* Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
* Post-radiation therapy - American Society for Radiation Oncology (ASTRO) - Phoenix consensus definition

* A rise of PSA measurement of 2 or more ng/mL over the nadir
* Able to provide written consent
* Karnofsky performance status of \> 50 (or Eastern Cooperative Oncology Group \[ECOG\] / World Health Organization \[WHO\] equivalent)

Exclusion Criteria

* Unable to provide informed consent
* Inability to lie still for the entire imaging time
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Andrei Iagaru

OTHER

Sponsor Role lead

Responsible Party

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Andrei Iagaru

Associate Professor of Radiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrei Iagaru

Role: PRINCIPAL_INVESTIGATOR

Stanford Cancer Institute Palo Alto

Locations

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Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Site Status

Countries

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United States

References

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Baratto L, Song H, Duan H, Hatami N, Bagshaw HP, Buyyounouski M, Hancock S, Shah S, Srinivas S, Swift P, Moradi F, Davidzon G, Iagaru A. PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2021 Nov;62(11):1545-1549. doi: 10.2967/jnumed.120.259630. Epub 2021 Mar 5.

Reference Type DERIVED
PMID: 33674398 (View on PubMed)

Other Identifiers

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NCI-2018-00479

Identifier Type: REGISTRY

Identifier Source: secondary_id

PROS0083

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-42701

Identifier Type: -

Identifier Source: org_study_id

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