Retrospective Analysis of 68Ga-PSMA-PET in Patients With Prostate Cancer: Experience From Brazil (PET-PSMA)

February 19, 2024 updated by: Latin American Cooperative Oncology Group
Gallium-68-prostate-specific membrane antigen (68Ga-PSMA) positron emission tomography (PET) has been increasingly used in the management of PCa in Brazil. Thus, the detection of metastatic lesions is improved over traditional methods e.g. MRI and the diagnosis of mCSPC patients has been proportionally increasing. Due to a lack of guidelines and clinical trials including 68Ga-PSMA-PET imaging, the management of these patients is extrapolated from data based on conventional imaging. Treatment decision and duration of treatment for mCSPC patients based on 68Ga-PSMA-PET imaging is currently unknown. 68Ga-PSMA-PET allows a diagnosis of a different set of low volume oligo-metastatic prostate cancer patients. Based on that, a new gap has been built up, since there are no standards of how those patients are managed and how they respond to conventional therapies, to metastasis direct therapy or even if they could be spared of any treatment, reducing costs and toxicities. This patient population has not been included in clinical trials and its critical to generate information on the diagnosis, treatment and outcome of these patients in clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil, 22.793-080
        • Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90.035-000
        • HMV - Hospital Moinhos de Vento
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90.610-000
        • CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with localized or biochemical recurrence prostate cancer with no detection of extra-prostatic disease in traditional imaging (bone scan and abdominal and pelvic CT or MRI) who underwent 68Ga-PSMA-PET imaging between October 2015 and January 202.

Description

Inclusion Criteria:

  1. Age of at least 18 years at study entry;
  2. Histologically confirmed adenocarcinoma of the prostate;
  3. 68Ga-PSMA-PET exam performed between October 2015 and January 2021;

  4. 68Ga-PSMA-PET performed in one of the following situations:

    • localized disease at diagnosis in patients with no detection of extra-prostatic disease in traditional imaging such as CT scan, MRI and bone scan;
    • biochemical recurrence (according to PCWG3 or defined by the investigator) in patients with no detection of prostatic or extra-prostatic disease in traditional imaging such as CT scan, MRI and bone scan;
  5. Traditional imaging (pelvic and abdominal CT or MRI and bone scan) with negative results (no extra-prostatic disease, for localized and biochemical recurrence disease; no prostatic for biochemical recurrence disease) performed within 8 weeks before 68Ga-PSMA-PET;
  6. Site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records.

Exclusion Criteria:

  1. Patients with no disease characteristics accessible in medical records;
  2. Cancer diagnosis other than prostate cancer in the last 5 years;
  3. Disease detected by traditional imaging techniques (bone scan, CT and/or MRI), meaning extra-prostatic disease, for localized and biochemical recurrence disease; or prostatic disease for biochemical recurrence disease.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Subjects with locally or biochemical recurrence prostate cancer
Radiation: 68Ga-PSMA-PET
Gallium-68-prostate-specific membrane antigen (68Ga-PSMA) positron emission tomography (PET)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The rate of patients with 68Ga-PSMA-PET positive lesions
Time Frame: January 2021
The rate of patients with 68Ga-PSMA-PET positive lesions [defined as the presence of lesions with 68Ga-PSMA uptake in the prostate (biochemical recurrence) and in extra-prostatic sites (localized disease and biochemical recurrence) in patients with no detected lesions in conventional imaging (no extra prostatic disease, for localized and biochemical recurrence disease; or prostatic disease for biochemical recurrence disease)]
January 2021

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
68Ga-PSMA-PET prostate cancer confirmed detection rate
Time Frame: January 2021
Defined as the proportion of patients with prostate cancer confirmed by histopathology or with PSA response (reduction ≥ 50% on PSA levels from baseline) in those treated with lesion-directed therapy without ADT in day + 90)
January 2021
Treatment patterns in evaluable patients based on 68Ga-PSMA-PET diagnostic status
Time Frame: January 2021
January 2021
The percentage of change in initial treatment plan considering the results of 68Ga-PSMA-PET in negative traditional imaging
Time Frame: January 2021
January 2021
To describe the type of disease monitoring imaging technique (i.e., CT scan, MRI, 68Ga-PSMA-PET) methods after initial diagnosis with 68Ga-PSMA-PET
Time Frame: January 2021
January 2021
Clinical effectiveness of first-line treatment based on 68Ga-PSMA-PET diagnostic status
Time Frame: January 2021
(no extra-prostatic disease - localized disease or local recurrence); nodal positive/metastasis negative (regional disease) and metastasis positive (distant disease)
January 2021
Treatment duration of first-line treatment based on 68Ga-PSMA-PET diagnostic status
Time Frame: January 2021
January 2021

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Latin American Cooperative Oncology Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrey Soares, Latin American Cooperative Oncology Group

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LACOG 0121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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