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Prostatic Neoplasms

Genital Neoplasms, Male

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Genital Diseases, Male

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Gallium 68 PSMA-11

Patients will receive a single administration of 99mTc-QULIC-5-P1

Each subject receives a single intravenous injection of 99mTc-QULIC-5-P1.

99mTc-QULIC-5-P1

Xiaoyang Zhang, PhD

99mTc-QULIC-5-P1 is a new radiotracer targeting PSMA, which is promising as an excellent imaging agent applicable to PSMA positive prostate cancer. This study will investigate the safety, biodistribution and potential usefulness of 99mTc-QULIC-5-P1 SPECT imaging for the diagnosis of lesions in PSMA positive prostate cancer.

99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer

99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer and Compared With 68Ga-PSMA-11 PET

The sensitivity, specificity, and accuracy of 99mTc-QULIC-5-P1 SPECT

First Affiliated Hospital of Chongqing Medical University

Principal Investigator

Adenocarcinoma

Central Nervous System Depressants

Anesthetics

Those patients' Multiparametric Prostate Magnetic Resonance (MPMR) imaging's have been assessed by a genitourinary radiologist to guide the surgeon who performs cognitive prostate biopsy

Those patients' Multiparametric Prostate Magnetic Resonance (MPMR) imaging's have not been assessed by a genitourinary radiologist to guide the surgeon who performs cognitive prostate biopsy. Surgeon assesses the Multiparametric Prostate Magnetic Resonance (MPMR) imaging's by him/herself

All patients will undergo prostate biopsy under local or general anesthesia with transrectal ultrasonography by a single surgeon after mapping extracted by a single genitourinary radiologist in the Department of Radiology of our hospital.

Performing cognitive prostate biopsy with a radiologist's guidance with map

All patients will undergo cognitive prostate biopsy under local or general anesthesia with transrectal ultrasonography by a single surgeon after reported by a single genitourinary radiologist in the Department of Radiology of our hospital.

Performing cognitive prostate biopsy without a radiologist's guidance with map

Yunus Emre Genc, MD.

Haydar Kamil Cam, Professor

Murat Kars, M.D.

Haydar Kamil Cam, Prof.

Today, many centers still perform Magnetic Resonance Imaging (MRI) cognitive prostate biopsy. The efficacy of detecting clinically significant prostate cancer, which is thought to be due to the experience of the urologist who performed the sampling and the difference in experience of the radiologists who performed the Multiparametric Prostate Magnetic Resonance (MPMR) evaluation, has been reported between 25% and 34% in the literature.

In order to eliminate this reporting and sampling difference, The goal of this interventional study is to compare the effectiveness of Multiparametric Prostate Magnetic Resonance (MPMR) Imaging routinely taken before biopsy with a single-center randomized and prospective study and prostate biopsies to be performed by the same urologist with the mapping technique created by a single genitourinary radiologist working in our center with standard cognitive prostate biopsy and to contribute to the literature Type of study: Clinical trial participant population: Male patients with elevated serum Prostate Specific Antigen (PSA) or indicated prostate biopsy by Magnetic Resonance Imaging (MRI) imaging and underwent Multiparametric Prostate Magnetic Resonance (MPMR) before the procedure Participants will undergo transrectal prostate biopsy with or without mapping, Researches will compare to see if the cancer detection rates differ

In this preliminary clinical study, 200 patients who underwent cognitive prostate biopsy under the guidance of transrectal ultrasonography between 01.03.2023 and 01.09.2023 by Marmara University Department of Urology, Department of Urooncology due to serum Prostate Specific Antigen (PSA) elevation and/or abnormal rectal examination findings will be included in the study. All patients will undergo prostate biopsy under local or general anesthesia with transrectal ultrasonography by a single surgeon after mapping or report is extracted by a single genitourinary radiologist in the Department of Radiology of our hospital.

In the power analysis, 200 patients were included in the study with the prediction that the efficacy difference would be calculated as 5%. All patients will be randomized to two equal groups by the flip-flip method.

1. Multiparametric Prostate Magnetic Resonance Imaging and reports of the mapped patients will be examined and cognitive prostate biopsy will be performed by looking at the map (Sample Figure 1,2) created by the same urologist and the same radiologist (Sample Figure 1,2). Standard 12 core (6 peripheral zones from both lobes) will be sampled and 4 extra biopsies will be taken from Prostate Imaging-Reporting and Data System (PI-RADS) Category 3-4-5 areas in the mapping.
2. Based on the Multiparametric Prostate Magnetic Resonance Imaging reports and images, without mapping by the radiologist, only the standard 12 core (6 from each peripheral zone from both lobes) determined cognitively by the urologist and 4 extra biopsies from the Prostate Imaging-Reporting and Data System (PI-RADS) Category 3-4-5 areas described in the report will be taken.

And then the biopsy results will be compared to see the efficacy of mapping

The Efficacy Of Mapping For Cognitive Prostate Biopsy

The Efficacy Of Mapping For Cognitive Prostate Biopsy: A Prospective, Randomized Study

Detection of any kind or any grade of prostate cancer on the pathological specimen of Transrectal Ultrasound Guided Prostate Biopsy:

* Detection of prostate adenocarcinoma of any ISUP (grade 1, grade 2, grade 3, grade 4 or grade 5) / Gleason score (Gleason score 6-10)
* Detection of non-adenocarcinoma cancers of prostate (small cell carcinoma, neuroendocrine tumor, sarcomatous carcinoma, signet ring cell, basaloid carcinoma, pseudohyperplastic carcinoma, lymphoepithelioma-like carcinoma, adenosquamous cell carcinoma)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
99mTc-QULIC-5-P1 SPECT Imaging in Patients With Prostate Cancer	NCT06419348	Prostate Cancer... PSMA SPECT	99mTc-QULIC-5-P...	18 Years -	First Affiliated Hospital of Chongqing Medical University
The Efficacy Of Mapping For Cognitive Prostate Biopsy	NCT05902637	Prostate Cancer Prostate Adenoc... Prostatic Neopl... Prostate Diseas... Prostate Cancer...	Performing cogn... Performing cogn...	40 Years - 90 Years	Marmara University

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