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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05073653
Recruitment Status : Recruiting
First Posted : October 11, 2021
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Diagnostic Test: 68Ga-PSMA PET/CT Diagnostic Test: 68Ga-GRP PET/CT Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study of 68Ga-GRP PET/CT for Imaging in Low and Intermediate Risk Prostate Cancer
Estimated Study Start Date : October 11, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Median Standardized Uptake Value (SUV) [ Time Frame: Day 0 (inclusion) or Day 2 to 21 ]
    Median Standardized Uptake Value (SUV) of 68Ga-GRP

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


Secondary Outcome Measures :
  1. 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

  2. Immunoreactive of lesion [ Time Frame: Day 3 to 60 ]
    Immunoreactive analysis of PSMA and GRPR


Other Outcome Measures:
  1. Correlation analysis between SUV and Gleason score [ Time Frame: Day 3 to 60 ]
    Correlation analysis


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05073653


Contacts
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Contact: Shuo Hu, PhD, MD +86 15874210819 hushuo_xy@163.com
Contact: Yongxiang Tang, PhD, MD +86 13549654360 xyyf0401@qq.com

Locations
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China, Hunan
Department of PET Center,Xiangya Hospital,Central South University Recruiting
Changsha, Hunan, China, 41008
Contact: Yongxiang Tang, PhD, MD    13549654360    xyyf0401@qq.com   
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
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Study Director: Shuo Hu, PhD, MD Department of PET Center,Xiangya Hospital,Central South University
More Information
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Publications of Results:

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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT05073653    
Other Study ID Numbers: 202110113
First Posted: October 11, 2021    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Xiangya Hospital of Central South University:
Prostate Cancer
68Ga-GRP PET/CT
68Ga-PSMA PET/CT
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
 Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Gallium 68 PSMA-11
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action