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

Sponsor
Xiangya Hospital of Central South University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05073653
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
14.7
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: 68Ga-PSMA PET/CT
  • Diagnostic Test: 68Ga-GRP PET/CT
N/A

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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Oct 11, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Median Standardized Uptake Value (SUV) [Day 0 (inclusion) or Day 2 to 21]

    Median Standardized Uptake Value (SUV) of 68Ga-GRP

  2. Median Standardized Uptake Value (SUV) [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 [Day 3 to 60]

    Gleason score was used to rank prostate cancer risk and was associated with SUV

  2. Immunoreactive of lesion [Day 3 to 60]

    Immunoreactive analysis of PSMA and GRPR

Other Outcome Measures

  1. Correlation analysis between SUV and Gleason score [Day 3 to 60]

    Correlation analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1Department of PET Center,Xiangya Hospital,Central South UniversityChangshaHunanChina41008

Sponsors and Collaborators

  • Xiangya Hospital of Central South University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier:
NCT05073653
Other Study ID Numbers:
  • 202110113
First Posted:
Oct 11, 2021
Last Update Posted:
Oct 19, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2021