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

Primary Purpose

Prostate Adenocarcinoma, PSA Level Greater Than 0.2, PSA Level Greater Than or Equal to Two

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Computed Tomography
Fluorine F 18 DCFPyL
Laboratory Biomarker Analysis
Positron Emission Tomography
Sponsored by
Andrei Iagaru
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Cancer Institute Palo Alto

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 10, 2018
Last Updated
January 6, 2022
Sponsor
Andrei Iagaru
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1. Study Identification

Unique Protocol Identification Number
NCT03501940
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrei Iagaru

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma, PSA Level Greater Than 0.2, PSA Level Greater Than or Equal to Two, PSA Progression, Recurrent Prostate Carcinoma

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Intervention Description
Undergo 18F-DCFPyL PET/CT
Intervention Type
Radiation
Intervention Name(s)
Fluorine F 18 DCFPyL
Other Intervention Name(s)
18F-DCFPyL
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo 18F-DCFPyL PET/CT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Iagaru
Organizational Affiliation
Stanford Cancer Institute Palo Alto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Cancer Institute Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33674398
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.
Results Reference
derived

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

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