NCT03515577

Brief Summary

This phase II trial compares how well gallium 68-labeled PSMA-11 positron emission tomography/computed tomography (PET/CT) works compared to fluciclovine F18 PET/CT in imaging participants with prostate cancer after surgery that has come back. PET is an established imaging technique that uses small amounts of radioactivity and CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. Diagnostic procedures, such as PET/CT with gallium 68-labeled PSMA-11, may work better than PET/CT with fluciclovine F18 in helping find out how far the prostate cancer has spread.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

April 12, 2019

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2019

Completed
Last Updated

October 14, 2020

Status Verified

June 1, 2019

Enrollment Period

13 days

First QC Date

April 20, 2018

Last Update Submit

October 12, 2020

Conditions

Recurrent Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Gallium 68-labeled PSMA-11 ([68]Ga-PSMA-11) and fluciclovine F18 (Axumin) detection rates

    Will compare rates for the identification of tumor location(s), assessed by patient and region based analysis. This will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using the Wilson score method. Detection rate in the per-participant analysis is defined as number of participants with PET positive disease, independent of pathology or imaging/clinical follow-up. Detection rate in the per-region analysis is defined as number of regions (prostate bed, pelvic lymph-nodes, extra-pelvic lymph-nodes, bone metastases, other soft tissue) resulted PET positive, independent of pathology or imaging/clinical follow-up.

    Up to 15 months: through data analysis completion (anonymized central imaging read), an estimation of 3 months after enrollment completion.

Secondary Outcomes (3)

  • Detection rates on a per-patient basis of 68^Ga-PSMA-11 PET and Axumin PET

    Up to 1 year after completion of PET/CT with 68^Ga-PSMA-11

  • Sensitivity and PPV by-participant and region-based analysis of 68^Ga-PSMA-11 PET and Axumin PET for detection of tumor location(s)

    Up to 1 year after completion of PET/CT with 68^Ga-PSMA-11

  • Inter-observer (reader) agreement

    Up to 15 months: through data analysis completion (anonymized central imaging read), an estimation of 3 months after enrollment completion.

Study Arms (1)

Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)

EXPERIMENTAL

Participants receive (68)Ga-PSMA-11 IV and 60-90 minutes later, undergo PET/CT imaging over 3 hours. Participants also undergo best standard of care Axumin PET/CT within 2 weeks before or after (68)Ga-PSMA-11 PET/CT.

Procedure: Computed TomographyDrug: Fluciclovine F18Drug: Gallium Ga 68-labeled PSMA-11Other: Laboratory Biomarker AnalysisProcedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)
Fluciclovine F18DRUG

Given fluciclovine F18

Also known as: (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC, Anti-(18f)FABC, Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid, Anti-[18F] FACBC, Axumin, Fluciclovine (18F), FLUCICLOVINE F-18, GE-148 (18F), GE-148 F-18
Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)
Gallium Ga 68-labeled PSMA-11DRUG

Given IV

Also known as: (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, 68Ga-HBED-CC-PSMA, 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, 68Ga-PSMA-11, [68Ga] Prostate-specific Membrane Antigen 11, [68Ga]GaPSMA-11, Ga-68 labeled PSMA-11, Gallium Ga 68 PSMA-11, Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, PSMA-HBED-CC GA-68
Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)
Positron Emission TomographyPROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)

Eligibility Criteria

Age19 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histopathologically proven prostate cancer (PCa)
  • Radical prostatectomy as definitive treatment for PCa
  • Proven biochemical recurrence as defined by American Urological Association (AUA) recommendation: PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after radical prostatectomy
  • PSA values ranging from 0.2 ng/mL to 2 ng/mL
  • No prior salvage therapies (including salvage radiotherapy and/or salvage lymph node dissection)
  • Axumin PET/CT scan already performed or scheduled as best standard of care procedure for suspected disease relapse within 2 weeks before or after intended 68Ga-PSMA-11 PET/CT
  • Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization \[WHO\] equivalent)
  • Ability to understand a written informed consent document and the willingness to sign it

You may not qualify if:

  • Any change in prostate cancer treatment between Axumin and 68Ga-PSMA PET/CT scan
  • Unable to lie flat, still or tolerate a PET scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • Calais J, Ceci F, Eiber M, Hope TA, Hofman MS, Rischpler C, Bach-Gansmo T, Nanni C, Savir-Baruch B, Elashoff D, Grogan T, Dahlbom M, Slavik R, Gartmann J, Nguyen K, Lok V, Jadvar H, Kishan AU, Rettig MB, Reiter RE, Fendler WP, Czernin J. 18F-fluciclovine PET-CT and 68Ga-PSMA-11 PET-CT in patients with early biochemical recurrence after prostatectomy: a prospective, single-centre, single-arm, comparative imaging trial. Lancet Oncol. 2019 Sep;20(9):1286-1294. doi: 10.1016/S1470-2045(19)30415-2. Epub 2019 Jul 30.

    PMID: 31375469RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fluciclovine F-18gallium 68 PSMA-11Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Johannes Czernin, M.D.

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2018

First Posted

May 3, 2018

Study Start

April 12, 2019

Primary Completion

April 25, 2019

Study Completion

April 25, 2019

Last Updated

October 14, 2020

Record last verified: 2019-06

Locations

US(1)