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Clinical Applications of Integrated PET/MR and PET/CT in the Diagnosis and Treatment of Prostate Cancer.

NCT06355843 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-04-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

68Ga-PSMA

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.

Sponsors & Collaborators

  • National Natural Science Foundation of China

    collaborator OTHER_GOV

  • The First Affiliated Hospital of Anhui Medical University

    lead OTHER

Principal Investigators

  • Huiqin Xu · The First Affiliated Hospital of Anhui Medical University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2023-09-30
Completion
2027-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06355843 on ClinicalTrials.gov