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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073653
• Other study ID #: 202110113
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Xiangya Hospital of Central South University
• Contact: Shuo Hu, PhD, MD
• Phone: +86 15874210819
• Email: hushuo_xy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 68Ga-PSMA PET/CT in patients with low and intermediate risk PCa.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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
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

Locations

Country	Name	City	State
China	Department of PET Center,Xiangya Hospital,Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (7)

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/ja — View Citation

Mansi R, Fleischmann A, Mäcke 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. Review. — View Citation

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, — View Citation

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. Erratum in: CA Cancer J Clin. 2021 Jul;71(4):359. — View Citation

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 — View Citation

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. — View Citation

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 (68)Ga-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation analysis between SUV and Gleason score	Correlation analysis	Day 3 to 60
Primary	Median Standardized Uptake Value (SUV)	Median Standardized Uptake Value (SUV) of 68Ga-GRP	Day 0 (inclusion) or Day 2 to 21
Primary	Median Standardized Uptake Value (SUV)	Median Standardized Uptake Value (SUV) of 68Ga-PSMA	Day 0 (inclusion) or Day 2 to 21
Secondary	Gleason score of lesion reported from pathological findings	Gleason score was used to rank prostate cancer risk and was associated with SUV	Day 3 to 60
Secondary	Immunoreactive of lesion	Immunoreactive analysis of PSMA and GRPR	Day 3 to 60