NCT05073653

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 19, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

September 28, 2021

Last Update Submit

October 10, 2021

Conditions

Prostate Cancer

Keywords

Prostate Cancer68Ga-GRP PET/CT68Ga-PSMA PET/CT

Outcome Measures

Primary Outcomes (2)

  • Median Standardized Uptake Value (SUV)

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

    Day 0 (inclusion) or Day 2 to 21

  • Median Standardized Uptake Value (SUV)

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

    Day 0 (inclusion) or Day 2 to 21

Secondary Outcomes (2)

  • Gleason score of lesion reported from pathological findings

    Day 3 to 60

  • Immunoreactive of lesion

    Day 3 to 60

Other Outcomes (1)

  • Correlation analysis between SUV and Gleason score

    Day 3 to 60

Study Arms (2)

68Ga-PSMA PET/CT Imaging

OTHER

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

68Ga-GRP PET/CT Imaging

OTHER

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

Interventions

68Ga-PSMA PET/CTDIAGNOSTIC_TEST

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-PSMA PET/CT Imaging
68Ga-GRP PET/CTDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • Claustrophobia (unable to accept PET/CT scanning).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of PET Center,Xiangya Hospital,Central South University

Changsha, Hunan, 41008, China

RECRUITING

Related Publications (7)

  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.

    PMID: 33433946RESULT

  • Fenton JJ, Weyrich MS, Durbin S, Liu Y, Bang H, Melnikow J. Prostate-Specific Antigen-Based Screening for Prostate Cancer: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2018 May 8;319(18):1914-1931. doi: 10.1001/jama.2018.3712.

    PMID: 29801018RESULT

  • Perera M, Papa N, Roberts M, Williams M, Udovicich C, Vela I, Christidis D, Bolton D, Hofman MS, Lawrentschuk N, Murphy DG. Gallium-68 Prostate-specific Membrane Antigen Positron Emission Tomography in Advanced Prostate Cancer-Updated Diagnostic Utility, Sensitivity, Specificity, and Distribution of Prostate-specific Membrane Antigen-avid Lesions: A Systematic Review and Meta-analysis. Eur Urol. 2020 Apr;77(4):403-417. doi: 10.1016/j.eururo.2019.01.049. Epub 2019 Feb 14.

    PMID: 30773328RESULT

  • Mansi R, Fleischmann A, Macke HR, Reubi JC. Targeting GRPR in urological cancers--from basic research to clinical application. Nat Rev Urol. 2013 Apr;10(4):235-44. doi: 10.1038/nrurol.2013.42. Epub 2013 Mar 19.

    PMID: 23507930RESULT

  • Wieser G, Mansi R, Grosu AL, Schultze-Seemann W, Dumont-Walter RA, Meyer PT, Maecke HR, Reubi JC, Weber WA. Positron emission tomography (PET) imaging of prostate cancer with a gastrin releasing peptide receptor antagonist--from mice to men. Theranostics. 2014 Feb 1;4(4):412-9. doi: 10.7150/thno.7324. eCollection 2014.

    PMID: 24578724RESULT

  • Zhang J, Niu G, Fan X, Lang L, Hou G, Chen L, Wu H, Zhu Z, Li F, Chen X. PET Using a GRPR Antagonist 68Ga-RM26 in Healthy Volunteers and Prostate Cancer Patients. J Nucl Med. 2018 Jun;59(6):922-928. doi: 10.2967/jnumed.117.198929. Epub 2017 Nov 9.

    PMID: 29123014RESULT

  • Touijer KA, Michaud L, Alvarez HAV, Gopalan A, Kossatz S, Gonen M, Beattie B, Sandler I, Lyaschenko S, Eastham JA, Scardino PT, Hricak H, Weber WA. Prospective Study of the Radiolabeled GRPR Antagonist BAY86-7548 for Positron Emission Tomography/Computed Tomography Imaging of Newly Diagnosed Prostate Cancer. Eur Urol Oncol. 2019 Mar;2(2):166-173. doi: 10.1016/j.euo.2018.08.011. Epub 2018 Sep 22.

    PMID: 31017093RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Shuo Hu, PhD, MD

    Department of PET Center,Xiangya Hospital,Central South University

    STUDY DIRECTOR

Central Study Contacts

Shuo Hu, PhD, MD

CONTACT

+86 15874210819hushuo_xy@163.com

Yongxiang Tang, PhD, MD

CONTACT

+86 13549654360xyyf0401@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 11, 2021

Study Start

October 11, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

October 19, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)