TheranosticTrials.org

Clinical Trial · NCT06355843

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

Overview

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.

Sponsor

The First Affiliated Hospital of Xiamen University

Phase

N/A

Contacts

Huiqin Xu (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06355843

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

Eligibility

Inclusion

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

Exclusion

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