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Recurrent Prostate CarcinomaPhase 2PSMA vs AXUMINNCT03515577

Gallium Ga 68-labeled PSMA-11 PET/CT and Fluciclovine F18 PET/CT in Imaging Participants With Recurrent Prostate Cancer After Surgery

A Phase 2 study testing Computed Tomography, Fluciclovine F18 and Gallium Ga 68-labeled PSMA-11 in people with Recurrent Prostate Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older, men only
Conditions the study is for
Recurrent Prostate Carcinoma
What is being tested?
Computed Tomography, Fluciclovine F18 and Gallium Ga 68-labeled PSMA-11
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
12 Apr 2019to 25 Apr 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Prospective Single Center Trial to Compare 68Ga-PSMA-11 and Axumin PET/CT (18F-Fluciclovine) for Restaging Prostate Cancer Patients With Biochemical Recurrence After Radical Prostatectomy

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the detection rates of gallium 68-labeled PSMA-11 ([68]Ga-PSMA-11) PET/CT and fluciclovine F18 (Axumin) PET/CT for the identification of tumor location(s), by patient and region based analysis.

SECONDARY OBJECTIVES:

  1. Detection rate on a per-patient basis of (68)Ga-PSMA-11 PET/CT and Axumin PET/CT, stratified by prostate-specific antigen (PSA) value (0.2 - < 0.5; 0.5 - < 1.0; 1.0 - < 2.0).

II. Sensitivity and positive predictive value (PPV) on a per-patient basis, of (68)Ga-PSMA-11 PET/CT and Axumin PET/CT for the detection of tumor location(s), confirmed by histopathology/biopsy and/or clinical and conventional imaging follow-up.

III. Agreement among the readers, separate for (68)Ga-PSMA-11 PET/CT versus Axumin PET/CT.

OUTLINE:

Participants receive (68)Ga-PSMA-11 intravenously (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.

After completion of the PET/CT scan, participants are followed up between 1 and 3 days and up to 12 months.

Being tested
Computed Tomography, Fluciclovine F18, Gallium Ga 68-labeled PSMA-11, Laboratory Biomarker Analysis, Positron Emission Tomography
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computerized Axial Tomography, computerized tomography

    Undergo PET/CT

  • Fluciclovine F18Drug

    Also called (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC

    Given fluciclovine F18

  • Gallium Ga 68-labeled PSMA-11Drug

    Also called (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

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET/CT

Study groups in NCT03515577
Study groupRoleWhat they receive
Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)ExperimentalParticipants 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.
Receives: Procedure: Computed Tomography; Drug: Fluciclovine F18; Drug: Gallium Ga 68-labeled PSMA-11; Other: Laboratory Biomarker Analysis; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

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

    This will be stratified by prostate-specific antigen (PSA) value (0.2 - < 0.5, 0.5 - < 1.0, 1.0 - < 2.0, 2.0 - < 5.0, ≥ 5.0) and will be summarized in tabular format and compared between PSA using chi-square analysis. Detection rate is defined as number of participants with PET positive disease, independent of pathology, imaging or clinical follow-up.

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

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

    The sensitivity and positive predictive values (PPV) 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. Only participants having histopathology/biopsy and/or clinical and conventional imaging follow-up will be analyzed

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

  3. Inter-observer (reader) agreement

    Agreement will be calculated separately for 68^Ga-PSMA-11 PET/CT versus Axumin PET/CT. For binary data, agreement among central readers will be evaluated using Fleiss' k. For non-binary data with more than ten observations, agreement among central readers will be evaluated by interclass correlation coefficient (ICC). Ninety-five percent confidence intervals (CIs) will be reported for k and ICC values. Interpretation of k and ICC will be based on a classification provided by Landis and Koch: 0.0, poor; 0.0-0.20, slight; 0.21-0.40, fair; 0.41-0.60, moderate; 0.61-0.80, substantial; 0.81-1.00, almost-perfect reproducibility.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2018
  2. Study start12 Apr 2019
  3. Primary completion25 Apr 2019
  4. Study completion25 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03515577
Sponsor's protocol ID
17-001885
Other IDs
NCI-2018-00546, 17-001885
Acronym
PSMA vs AXUMIN
Status last verified
Jun 2019
First submitted
20 Apr 2018
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 31375469

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Computed Tomography, Fluciclovine F18 and Gallium Ga 68-labeled PSMA-11 in people with Recurrent Prostate Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gallium 68-labeled PSMA-11 ([68]Ga-PSMA-11) and fluciclovine F18 (Axumin) detection rates (time frame: Up to 15 months: through data analysis completion (anonymized central imaging read), an estimation of 3 months after enrollment completion.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03515577, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.

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