Clinical trial · Interventional
Clinical Applications of Integrated PET/MR and PET/CT in the Diagnosis and Treatment of Prostate Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The 68Ge/68Ga generator is currently at the end of its lifespan. We are trying to purchase new equipment, which will take about half a year.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pet-ct | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-FAPI PET/MRI scan
- description
- 68Ga-PSMA PET/CT (PET/MR) before surgery or biopsy
- interventionNames
- Drug: 68Ga-PSMA
Primary outcomes (2)
- measure
- 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
- timeFrame
- up to 28 months
- description
- 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.
- measure
- Exploring whether 68Ga-PSMA PET/MRI can be used as a method for diagnostic efficacy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18 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. Exclusion Criteria: * Those with severe psychiatric symptoms, or those who are too confused to cooperate with the examination; * Those with poor compliance.
References
Publications (21)
- RESULTPishgar 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 29129779
- RESULTSchoder 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 15493005
- RESULTBrawer 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 1289676
- RESULTJadvar 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 21149473
- RESULTChoueiri 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 18207194
- RESULTHeidenreich 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 24207135
- RESULTBarentsz 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.