Clinical trial NCT03501940: F18 DCFPyL PET/CT in Imaging Participants With Recurrent Prostate Cancer
Official title: 18F-DCFPyL PET/CT in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer and Non-Contributory CT Scans
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Prostate Adenocarcinoma
PSA Level Greater Than 0.2
PSA Level Greater Than or Equal to Two
PSA Progression
Recurrent Prostate Carcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-04-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cancer Institute Palo Alto
state: California
Study officials:
affiliation: Stanford Cancer Institute Palo Alto
name: Andrei Iagaru
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.