A Study of 68Ga-GRP PET/CT for Imaging in Low and Intermediate Risk Prostate Cancer

October 10, 2021 updated by: Xiangya Hospital of Central South University

Patients with primary low and intermediate risk prostate cancer (PCa) for whom radical prostatectomy are indicated, will be invited to participate to the present study.

The aim of this study is to investigate the clinical value of 68Ga-GRP positron emission tomography / computed tomography (PET/CT) compared to 68Ga-PSMA PET/CT in patients with low and intermediate risk PCa.

Study Overview

Status

Status

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

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.

Detailed Description

Prostate cancer (PCa) is the second-most common cancer among men across the world, and a significant cause of death in many regions. Different stages of PCa directly affect both the therapeutic schedule and patient prognosis.

Recommended imaging modalities for initial staging include computerized tomography (CT) scan, bone scan, and Magnetic Resonance Imaging (MRI). In addition to initial work-up, Gallium-68 prostate-specific membrane antigen positron emission tomography/computer tomography (68Ga-PSMA PET/CT) is a relatively new nuclear imaging modality, showing high sensitivity and specificity. Recently, several studies have investigated the role of 68Ga-PSMA PET/CT in a first-line diagnostic setting, especially in patients with high-risk and biochemically recurrent PCa.

Therefore, PET imaging with 68Ga-PSMA may participate to optimize work-up in the staging of high-risk patients.

Another family of radiopharmaceuticals aimed to target the Gastrin-Releasing Peptide Receptor (GRP-R) which is overexpressed in early stage PCa. Various radiolabeled GRP analogues have been developed and shown encouraging results as related to the detection of primary PCa in preclinical study. However, 68Ga-GRP failed to detect some bone metastases in hormone-refractory patients. A prospective study identified that GRPR expression is not associated with Gleason score (GS) and PSMA expression, suggesting that 68Ga-GRP and 68Ga-PSMA PET/CT may be complementary in various risks of PCa diagnosis.

The aim of this pilot study is to compare 68Ga-PSMA PET/CT to 68Ga-GRP PET/CT in patients with PCa of low and intermediate risk to better understand how 68Ga-PSMA and 68Ga-GRP PET/CT could performed a primary lesion mapping and how 68Ga-PSMA and 68Ga-GRP PET/CT could be used (or combined) in clinical practice.

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.
Interventional

Enrollment (Anticipated)

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.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Name: Yongxiang Tang, PhD, MD
  • Phone Number: +86 13549654360
  • Email: xyyf0401@qq.com

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 41008
        • Recruiting
        • Department of PET Center,Xiangya Hospital,Central South University
        • Contact:

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • patients divided in :

    • Patients with low risk prostate cancer (Gleason score ≤ 6 and cT1-T2a and Prostate Specific Antigen (PSA) value < 10 ng/mL);
    • Patients with intermediate risk prostate cancer (Gleason score 7 or cT2b or PSA value 10-20 ng/mL);
    • Patients with high risk prostate cancer (Gleason > 7 or cT2c or PSA value > 20 ng/mL);
    • Candidate for radical prostatectomy after discussion in multidisciplinary committee;
    • Written informed consent willingly obtained.

Exclusion Criteria:

  • Any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc…);
  • Patient not candidate for radical prostatectomy and/or unable to benefit from surgery;
  • Patient under legal protection or unable to express its own consent;
  • Patient within exclusion period from another clinical trial;
  • Claustrophobia (unable to accept PET/CT scanning).

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Other: 68Ga-PSMA PET/CT Imaging
Injection of the radioligand 68Ga-PSMA; Device: PET/CT; Following injection of 68Ga-PSMA, the participants will be subjected to whole body PET/CT.
Diagnostic test: 68Ga-PSMA PET/CT
Exploratory, Single-institution Study, Comparing 68Ga-GRP PET/CT Versus 68Ga-PSMA PET/CT in Patients Diagnosed With Prostate Cancer of Low and Intermediate Risk for Radical Prostatectomy
Other: 68Ga-GRP PET/CT Imaging
Injection of the radioligand 68Ga-GRP; Device: PET/CT; Following injection of 68Ga-GRP, the participants will be subjected to whole body PET/CT.
Diagnostic test: 68Ga-GRP PET/CT
Exploratory, Single-institution Study, Comparing 68Ga-GRP PET/CT Versus 68Ga-PSMA PET/CT in Patients Diagnosed With Prostate Cancer of Low and Intermediate Risk for Radical Prostatectomy

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
Median Standardized Uptake Value (SUV)
Time Frame: Day 0 (inclusion) or Day 2 to 21
Median Standardized Uptake Value (SUV) of 68Ga-GRP
Day 0 (inclusion) or Day 2 to 21
Median Standardized Uptake Value (SUV)
Time Frame: Day 0 (inclusion) or Day 2 to 21
Median Standardized Uptake Value (SUV) of 68Ga-PSMA
Day 0 (inclusion) or Day 2 to 21

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
Gleason score of lesion reported from pathological findings
Time Frame: Day 3 to 60
Gleason score was used to rank prostate cancer risk and was associated with SUV
Day 3 to 60
Immunoreactive of lesion
Time Frame: Day 3 to 60
Immunoreactive analysis of PSMA and GRPR
Day 3 to 60

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation analysis between SUV and Gleason score
Time Frame: Day 3 to 60
Correlation analysis
Day 3 to 60

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.
Xiangya Hospital of Central South University

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.
  • Study Director: Shuo Hu, PhD, MD, Department of PET Center,Xiangya Hospital,Central South University

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 (Anticipated)

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.
October 11, 2021

Primary Completion (Anticipated)

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.
December 31, 2022

Study Completion (Anticipated)

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.
December 31, 2022

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).
September 28, 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.
September 28, 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.
October 11, 2021

Study Record Updates

Last Update Posted (Actual)

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.
October 19, 2021

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.
October 10, 2021

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.
September 1, 2021

More Information

Terms related to this study

Keywords

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.
  • 202110113

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

product manufactured in and exported from the U.S.

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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Conditions

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