NCT06355843

Brief Summary

The goal of this study type: observational study (prospective study) is to study prostate cancer occurrence and recurrence, to specifically identify and localize tumor foci at the molecular level at an early stage, to evaluate the prognosis of patients, and to accurately stage not only intermediate- and high-risk prostate cancer patients with a primary diagnosis, but also detect recurrent foci in patients with biochemical recurrence, to restage those who have developed metastases, to assess tumor load, and to ultimately assist in determining the personalized treatment plans. The main question it aims to answer is whether 68Ga-PSMA PET/CT (PET/MR) examination is beneficial for assessing the

  • Accurate staging of patients with intermediate- and high-risk prostate cancer at first diagnosis;
  • Detecting recurrent lesions in patients with recurrent tumors for re-staging;
  • Assessment of tumor load;
  • Assessment of patient prognosis. Participants will sign an informed consent form, undergo 68Ga-PSMA PET/CT (PET/MR) before surgery or biopsy, and have regular follow-up after obtaining pathological results of surgical resection or puncture biopsy, 6 weeks after surgery or biopsy, and then every 3 months; the follow-up will include: blood PSA, whole-body bone imaging, etc.

Trial Health

53
Monitor

Trial Health Score

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

Trial recruitment is currently suspended
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
11mo left

Started Apr 2022

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
suspended

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

Study Progress82%
Apr 2022Mar 2027

Study Start

First participant enrolled

April 28, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Expected
Last Updated

April 9, 2024

Status Verified

September 1, 2023

Enrollment Period

1.4 years

First QC Date

January 23, 2024

Last Update Submit

April 3, 2024

Conditions

Prostate CancerPet-ct

Keywords

PSMAPET/MRIProstate Cancer

Outcome Measures

Primary Outcomes (2)

  • Measuring the value of 68Ga-PSMA PET/MRI in the diagnosis and staging of primary prostate cancer and comparing it with mp-MRI and PET/CT

    68Ga-PSMA-11 PET/MRI and multiparametric MRI images of participants with suspected prostate cancer were collected and compared with 68Ga-PSMA-11 PET/MRI, 68Ga-PSMA-11 PET and multiparametric MRI for the diagnosis of prostate cancer, using histopathological findings as the "gold standard". Accuracy, sensitivity, specificity, positive and negative predictive values were calculated. The diagnostic efficacy of the three was analyzed by plotting the working characteristic curves of the subjects.

    up to 28 months

  • Exploring whether 68Ga-PSMA PET/MRI can be used as a method for diagnostic efficacy

    68Ga-PSMA-11 PET/MRI images of prostate cancer patients were collected, and the histopathological findings were used as the "gold standard". The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of 68Ga-PSMA-11 PET/MRI for diagnosing T, N, and M stages of prostate cancer were calculated. The working characteristic curves of the subjects were plotted and their diagnostic efficacy was calculated by the area under the curve.

    up to 32 months

Study Arms (1)

68Ga-FAPI PET/MRI scan

EXPERIMENTAL

68Ga-PSMA PET/CT (PET/MR) before surgery or biopsy

Drug: 68Ga-PSMA

Interventions

68Ga-PSMADRUG

PSMA is located in prostate epithelial cells and is converted to a membrane-bound protein in prostate cancer, and PSMA expression is approximately 100 to 1000 times higher in prostate cancer tissue compared to normal prostate tissue. PSMA is expressed at high levels in 95% of prostate cancer patients and is upregulated in castration-resistant prostate cancer (CRPC) and metastatic prostate cancer. PSMA expression was also increased after androgen deprivation therapy (ADT). The use of positronuclide 68Ga-labelled PSMA small molecule inhibitors can be specifically combined with prostate cancer cells, and it is important for the diagnosis of prostate cancer and its metastatic foci through PET/CT and PET/MR visualisation. With the popularity of integrated PET/MR imaging, combining the higher resolution and morphological performance of MR imaging with the N-staging and M-staging of PET, the specificity of primary prostate cancer diagnosis can be greatly improved.

68Ga-FAPI PET/MRI scan

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years ≤ 75 years of age;
  • Patients with clinical suspicion of prostate cancer;
  • No recent invasive tests or treatments were performed;
  • Blood count: leukocytes\>4×109/L, neutrophils\>2×109/L, haemoglobin\>90g/L, platelets\>100×109/L;
  • Cardiac function: left ventricular ejection fraction \>50%;
  • Pulmonary function tests: FEV1 ≥1.2L, FEV1% ≥50% and DLCO ≥50%;
  • Liver function: total bilirubin \<1.5 times upper limit of normal (ULN); AST and ALT \<1.5 times ULN;
  • Renal function: serum creatinine ≤ 1.5 times ULN, or glomerular filtration rate \> 60 ml/min;
  • Participants agreed to participate in this clinical trial and signed an informed consent form;
  • Good compliance and commitment to follow the study procedures and to cooperate in the implementation of the full study;
  • No birth plans for six months.

You may not qualify if:

  • Those with severe psychiatric symptoms, or those who are too confused to cooperate with the examination;
  • Those with poor compliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First affiliated hospital of anhui university

Hefei, Anhui, 230032, China

Location

Related Publications (21)

  • Pishgar F, Ebrahimi H, Saeedi Moghaddam S, Fitzmaurice C, Amini E. Global, Regional and National Burden of Prostate Cancer, 1990 to 2015: Results from the Global Burden of Disease Study 2015. J Urol. 2018 May;199(5):1224-1232. doi: 10.1016/j.juro.2017.10.044. Epub 2017 Nov 9.

    PMID: 29129779RESULT

  • Schoder H, Larson SM. Positron emission tomography for prostate, bladder, and renal cancer. Semin Nucl Med. 2004 Oct;34(4):274-92. doi: 10.1053/j.semnuclmed.2004.06.004.

    PMID: 15493005RESULT

  • Brawer MK, Ploch NR, Bigler SA. Prostate cancer tumor location as predicted by digital rectal examination transferred to ultrasound and ultrasound-guided prostate needle biopsy. J Cell Biochem Suppl. 1992;16H:74-7. doi: 10.1002/jcb.240501217.

    PMID: 1289676RESULT

  • Jadvar H. Prostate cancer: PET with 18F-FDG, 18F- or 11C-acetate, and 18F- or 11C-choline. J Nucl Med. 2011 Jan;52(1):81-9. doi: 10.2967/jnumed.110.077941. Epub 2010 Dec 13.

    PMID: 21149473RESULT

  • Choueiri TK, Dreicer R, Paciorek A, Carroll PR, Konety B. A model that predicts the probability of positive imaging in prostate cancer cases with biochemical failure after initial definitive local therapy. J Urol. 2008 Mar;179(3):906-10; discussion 910. doi: 10.1016/j.juro.2007.10.059. Epub 2008 Jan 22.

    PMID: 18207194RESULT

  • Heidenreich A, Bastian PJ, Bellmunt J, Bolla M, Joniau S, van der Kwast T, Mason M, Matveev V, Wiegel T, Zattoni F, Mottet N; European Association of Urology. EAU guidelines on prostate cancer. part 1: screening, diagnosis, and local treatment with curative intent-update 2013. Eur Urol. 2014 Jan;65(1):124-37. doi: 10.1016/j.eururo.2013.09.046. Epub 2013 Oct 6.

    PMID: 24207135RESULT

  • Barentsz JO, Weinreb JC, Verma S, Thoeny HC, Tempany CM, Shtern F, Padhani AR, Margolis D, Macura KJ, Haider MA, Cornud F, Choyke PL. Synopsis of the PI-RADS v2 Guidelines for Multiparametric Prostate Magnetic Resonance Imaging and Recommendations for Use. Eur Urol. 2016 Jan;69(1):41-9. doi: 10.1016/j.eururo.2015.08.038. Epub 2015 Sep 8. No abstract available.

    PMID: 26361169RESULT

  • Sivaraman A, Sanchez-Salas R. Re: can clinically significant prostate cancer be detected with multiparametric magnetic resonance imaging? A systematic review of the literature. Eur Urol. 2015 Oct;68(4):738. doi: 10.1016/j.eururo.2015.06.033. No abstract available.

    PMID: 26334122RESULT

  • Grivas N, Lardas M, Espinos EL, Lam TB, Rouviere O, Mottet N, van den Bergh RCN; Members of the EAU-EANM-ESTRO-ESUR-ISUP-SIOG Prostate Cancer Guidelines Panel. Prostate Cancer Detection Percentages of Repeat Biopsy in Patients with Positive Multiparametric Magnetic Resonance Imaging (Prostate Imaging Reporting and Data System/Likert 3-5) and Negative Initial Biopsy. A Mini Systematic Review. Eur Urol. 2022 Nov;82(5):452-457. doi: 10.1016/j.eururo.2022.07.025. Epub 2022 Aug 18.

    PMID: 35985901RESULT

  • Hovels AM, Heesakkers RA, Adang EM, Jager GJ, Strum S, Hoogeveen YL, Severens JL, Barentsz JO. The diagnostic accuracy of CT and MRI in the staging of pelvic lymph nodes in patients with prostate cancer: a meta-analysis. Clin Radiol. 2008 Apr;63(4):387-95. doi: 10.1016/j.crad.2007.05.022. Epub 2008 Feb 4.

    PMID: 18325358RESULT

  • Gorin MA, Rowe SP, Denmeade SR. Clinical Applications of Molecular Imaging in the Management of Prostate Cancer. PET Clin. 2017 Apr;12(2):185-192. doi: 10.1016/j.cpet.2016.11.001. Epub 2017 Jan 16.

    PMID: 28267452RESULT

  • Jani AB, Schreibmann E, Rossi PJ, Shelton J, Godette K, Nieh P, Master VA, Kucuk O, Goodman M, Halkar R, Cooper S, Chen Z, Schuster DM. Impact of 18F-Fluciclovine PET on Target Volume Definition for Postprostatectomy Salvage Radiotherapy: Initial Findings from a Randomized Trial. J Nucl Med. 2017 Mar;58(3):412-418. doi: 10.2967/jnumed.116.176057. Epub 2016 Sep 8.

    PMID: 27609792RESULT

  • Park SY, Zacharias C, Harrison C, Fan RE, Kunder C, Hatami N, Giesel F, Ghanouni P, Daniel B, Loening AM, Sonn GA, Iagaru A. Gallium 68 PSMA-11 PET/MR Imaging in Patients with Intermediate- or High-Risk Prostate Cancer. Radiology. 2018 Aug;288(2):495-505. doi: 10.1148/radiol.2018172232. Epub 2018 May 22.

    PMID: 29786490RESULT

  • Lutje S, Heskamp S, Cornelissen AS, Poeppel TD, van den Broek SA, Rosenbaum-Krumme S, Bockisch A, Gotthardt M, Rijpkema M, Boerman OC. PSMA Ligands for Radionuclide Imaging and Therapy of Prostate Cancer: Clinical Status. Theranostics. 2015 Oct 18;5(12):1388-401. doi: 10.7150/thno.13348. eCollection 2015.

    PMID: 26681984RESULT

  • Demirkol MO, Acar O, Ucar B, Ramazanoglu SR, Saglican Y, Esen T. Prostate-specific membrane antigen-based imaging in prostate cancer: impact on clinical decision making process. Prostate. 2015 May;75(7):748-57. doi: 10.1002/pros.22956. Epub 2015 Jan 18.

    PMID: 25598074RESULT

  • Liu T, Wu LY, Fulton MD, Johnson JM, Berkman CE. Prolonged androgen deprivation leads to downregulation of androgen receptor and prostate-specific membrane antigen in prostate cancer cells. Int J Oncol. 2012 Dec;41(6):2087-92. doi: 10.3892/ijo.2012.1649. Epub 2012 Oct 4.

    PMID: 23041906RESULT

  • Eder M, Schafer M, Bauder-Wust U, Hull WE, Wangler C, Mier W, Haberkorn U, Eisenhut M. 68Ga-complex lipophilicity and the targeting property of a urea-based PSMA inhibitor for PET imaging. Bioconjug Chem. 2012 Apr 18;23(4):688-97. doi: 10.1021/bc200279b. Epub 2012 Mar 13.

    PMID: 22369515RESULT

  • Weineisen M, Simecek J, Schottelius M, Schwaiger M, Wester HJ. Synthesis and preclinical evaluation of DOTAGA-conjugated PSMA ligands for functional imaging and endoradiotherapy of prostate cancer. EJNMMI Res. 2014 Dec;4(1):63. doi: 10.1186/s13550-014-0063-1. Epub 2014 Nov 25.

    PMID: 26116124RESULT

  • Benesova M, Schafer M, Bauder-Wust U, Afshar-Oromieh A, Kratochwil C, Mier W, Haberkorn U, Kopka K, Eder M. Preclinical Evaluation of a Tailor-Made DOTA-Conjugated PSMA Inhibitor with Optimized Linker Moiety for Imaging and Endoradiotherapy of Prostate Cancer. J Nucl Med. 2015 Jun;56(6):914-20. doi: 10.2967/jnumed.114.147413. Epub 2015 Apr 16.

    PMID: 25883127RESULT

  • Afshar-Oromieh A, Zechmann CM, Malcher A, Eder M, Eisenhut M, Linhart HG, Holland-Letz T, Hadaschik BA, Giesel FL, Debus J, Haberkorn U. Comparison of PET imaging with a (68)Ga-labelled PSMA ligand and (18)F-choline-based PET/CT for the diagnosis of recurrent prostate cancer. Eur J Nucl Med Mol Imaging. 2014 Jan;41(1):11-20. doi: 10.1007/s00259-013-2525-5. Epub 2013 Sep 27.

    PMID: 24072344RESULT

  • Afshar-Oromieh A, Hetzheim H, Kratochwil C, Benesova M, Eder M, Neels OC, Eisenhut M, Kubler W, Holland-Letz T, Giesel FL, Mier W, Kopka K, Haberkorn U. The Theranostic PSMA Ligand PSMA-617 in the Diagnosis of Prostate Cancer by PET/CT: Biodistribution in Humans, Radiation Dosimetry, and First Evaluation of Tumor Lesions. J Nucl Med. 2015 Nov;56(11):1697-705. doi: 10.2967/jnumed.115.161299. Epub 2015 Aug 20.

    PMID: 26294298RESULT

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

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

Study Officials

  • Huiqin Xu

    The First Affiliated Hospital of Anhui Medical University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 23, 2024

First Posted

April 9, 2024

Study Start

April 28, 2022

Primary Completion

September 30, 2023

Study Completion (Estimated)

March 31, 2027

Last Updated

April 9, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Locations

CN(1)