68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients With Prostate Cancer

September 29, 2021 updated by: Jonsson Comprehensive Cancer Center

Impact of 68GA-PSMA-11 PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer

This phase II trial studies the impact of 68GA-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan on treatment strategies for patients with prostate cancer. Diagnostic imaging procedures, such as 68GA-PSMA-11 PET/CT scan, may help doctors plan the best treatment for prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the impact of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET/CT on initial and subsequent treatment strategies of patients with prostate cancer.

OUTLINE:

Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.

After completion of study, patients are followed up within 3-12 months.

Study Type

Interventional

Enrollment (Actual)

937

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients who fulfill criteria for initial staging or restaging as outlined below:

    • Initial treatment strategy decisions (initial staging): All patients with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high prostate-specific antigen (PSA) levels (> 50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies:

      • Surgery
      • External radiation therapy (RT)
      • Other focal therapies
      • Systemic medical treatment
      • Watchful waiting

    • Assessment for subsequent treatment strategy (restaging), any of the following:

      • Patients with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following:

        • Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP
        • Post-radiation therapy: Nadir + greater than or equal to 2 ng/mL rise in PSA
      • Patients with known prostate cancer who undergo restaging because of new symptoms
      • Patients with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging
      • Patients with known prostate cancer who are treated medically or with radioligand therapy (RLT) in whom response to treatment is assessed
      • Note: Patients may be reenrolled in the study, if 68Ga-PSMA PET/CT is performed for subsequent management decision
  • Capability to provide written informed consent
  • Able to remain still for duration of each imaging procedure (about 30 minutes)

Exclusion Criteria:

  • 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 concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
  • Inability to provide written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diagnostic (68Ga-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision.
Other: Questionnaire Administration
Ancillary studies
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • tomography
  • computerized tomography
  • CT SCAN
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Drug: Gallium Ga 68-labeled PSMA-11
Given IV
Other Names:
  • (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)Glu-urea-Lys(Ahx)-HBED-CC
  • 68Ga-DKFZ-PSMA-11
  • 68Ga-HBED-CC-PSMA
  • 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC
  • 68Ga-PSMA
  • 68Ga-PSMA-11
  • 68Ga-PSMA-HBED-CC
  • [68Ga] Prostate-specific Membrane Antigen 11
  • [68Ga]GaPSMA-11
  • Ga PSMA
  • Ga-68 labeled DKFZ-PSMA-11
  • Ga-68 labeled PSMA-11
  • Gallium Ga 68 PSMA-11
  • Gallium-68 PSMA
  • Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
  • GaPSMA
  • PSMA-HBED-CC GA-68

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intended and implemented management changes after gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT)
Time Frame: Up to 3-6 months after completion of imaging
A separate analysis of initial versus subsequent management will be performed. Will be evaluated using descriptive statistics for both the treatment modality analysis and the disease stage based management analysis. Questionnaires will be collected to determine the intended patient management before and intended management changes after PET/CT, and to determine whether intended management changes were implemented. The outcome measure is the rate of change (%) as assessed by the questionnaires before and after PET.
Up to 3-6 months after completion of imaging

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for biochemical progression-free survival (PFS)
Time Frame: From inclusion to date until PSA progression or death (whichever occurs first), assessed up to 12 months
From inclusion to date until PSA progression or death (whichever occurs first), assessed up to 12 months
Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for radiographic PFS
Time Frame: From inclusion to date until first site of disease is found to progress or death (whichever occurs first), assessed up to 12 months
Nodal and visceral disease will be evaluated on cross-sectional imaging using Response Evaluation Criteria in Solid Tumors 1.1/Prostate Cancer Working Group 3 (PCWG3) criteria. Bone metastases will be evaluated using bone scintigraphy and new lesions have to be confirmed on a second scan (2+2 rule) using PCWG3 criteria.
From inclusion to date until first site of disease is found to progress or death (whichever occurs first), assessed up to 12 months
Prognostic value of the 68Ga-PSMA-11 PET/CT miTNM classification for overall survival
Time Frame: From inclusion to date of death, assessed up to 12 months
From inclusion to date of death, assessed up to 12 months
Positive predictive value (PPV) on a per-patient and per-region basis of 68Ga-PSMA-11 PET for detection of tumor location
Time Frame: Up to 12 months
Confirmed by histopathology/biopsy or follow-up assessed separately for initial staging and restaging. 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. PPV will be reported for each of the three blinded readers independently. Detection rates on a per-patient basis of 68Ga-PSMA-11 PET stratified by prostate-specific antigen (PSA) value will be summarized in tabular format and compared between PSA strata using chi-square analysis. Detection rate is defined as number of patients with PSMA positive disease, independent of pathology, imaging or clinical follow-up. A detection rate will be reported for each reader independently stratified by PSA.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 2, 2018

Primary Completion (ACTUAL)

September 27, 2021

Study Completion (ACTUAL)

September 27, 2021

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (ACTUAL)

August 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-001336
  • NCI-2019-04439 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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