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Prostate CancerNCT05073653

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

A study testing 68Ga-PSMA PET/CT and 68Ga-GRP PET/CT in people with Prostate Cancer, run by Xiangya Hospital of Central South University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
68Ga-PSMA PET/CT and 68Ga-GRP PET/CT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
11 Oct 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Shuo Hu, PhD, MD contact

+86 15874210819

hushuo_xy@163.com

Yongxiang Tang, PhD, MD contact

+86 13549654360

xyyf0401@qq.com

China1 site, 1 recruiting

  • Department of PET Center,Xiangya Hospital,Central South University

    Changsha, Hunan, 41008

    Yongxiang Tang, PhD, MD, 13549654360, xyyf0401@qq.com

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
68Ga-PSMA PET/CT, 68Ga-GRP PET/CT
Keywords
Prostate Cancer, 68Ga-GRP PET/CT, 68Ga-PSMA PET/CT
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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-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

Study groups in NCT05073653
Study groupRoleWhat they receive
68Ga-PSMA PET/CT ImagingOtherInjection of the radioligand 68Ga-PSMA; Device: PET/CT; Following injection of 68Ga-PSMA, the participants will be subjected to whole body PET/CT.
Receives: Diagnostic Test: 68Ga-PSMA PET/CT
68Ga-GRP PET/CT ImagingOtherInjection of the radioligand 68Ga-GRP; Device: PET/CT; Following injection of 68Ga-GRP, the participants will be subjected to whole body PET/CT.
Receives: Diagnostic Test: 68Ga-GRP PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Standardized Uptake Value (SUV)

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

    Measured: Day 0 (inclusion) or Day 2 to 21

  2. Median Standardized Uptake Value (SUV)

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

    Measured: Day 0 (inclusion) or Day 2 to 21

Secondary outcomes (2)

  1. Gleason score of lesion reported from pathological findings

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

    Measured: Day 3 to 60

  2. Immunoreactive of lesion

    Immunoreactive analysis of PSMA and GRPR

    Measured: Day 3 to 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2021
  2. Study start11 Oct 2021 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05073653
Sponsor's protocol ID
202110113
Status last verified
Sep 2021
First submitted
28 Sep 2021
Last updated
19 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33433946

  • 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.

    PubMed 29801018

  • 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.

    PubMed 30773328

  • 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.

    PubMed 23507930

  • 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.

    PubMed 24578724

  • 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.

    PubMed 29123014

  • 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.

    PubMed 31017093

  • Tang W, Qi L, Chen M, Zhang Y, Tang Y, Hu S, Gao X, Cai Y. Additive Value of [68Ga]Ga-RM26 PET/CT to [68Ga]Ga-PSMA-617 PET/CT in Detecting Pelvic Lymph Node Metastasis in Prostate Cancer: A Prospective, Single-Center, Phase II Study. J Nucl Med. 2025 May 1;66(5):719-725. doi: 10.2967/jnumed.124.269189.

    PubMed 40113221

Questions about this trial

What is this clinical trial studying?

A study testing 68Ga-PSMA PET/CT and 68Ga-GRP PET/CT in people with Prostate Cancer, run by Xiangya Hospital of Central South University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shuo Hu, PhD, MD (+86 15874210819, hushuo_xy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Standardized Uptake Value (SUV) (time frame: Day 0 (inclusion) or Day 2 to 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05073653, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.

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