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Prostatic Neoplasms clinical trials

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NCT ID: NCT06362577 Not yet recruiting - Clinical trials for Localized Prostate Cancer

Clinical Study of HIFU for Localized Prostate Cancer

HIFU
Start date: April 15, 2024
Phase:
Study type: Observational

In this study, the safety and effectiveness data of Sonablate system, a transrectal high-intensity focused ultrasound therapeutic instrument, in the treatment of localized prostate cancer were collected, and the treatment conditions of patients with other methods (such as radical prostatectomy) were compared and analyzed. Observe the differences in treatment effect, survival rate, postoperative PSA, recurrence and complications. To analyze and compare the clinical outcome, postoperative complications and tumor control of HIFU and robot-assisted laparoscopic radical prostatectomy for localized prostate cancer, and to explore the effectiveness and safety of HIFU in the treatment of localized prostate cancer, so as to provide an alternative treatment for localized prostate cancer.

NCT ID: NCT06360523 Not yet recruiting - Prostate Cancer Clinical Trials

To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence

Start date: May 1, 2024
Phase:
Study type: Observational

It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 102 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.

NCT ID: NCT06359964 Not yet recruiting - Prostate Cancer Clinical Trials

Infective Complications in TP Biopsy Without Antibiotic Prophylaxis

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This study is a prospective cohort study to delineate the infective outcomes and incidence after transperineal prostate biopsy with no antibiotic prophylaxis, compared to the existing data on outcomes on patients receiving transperineal prostate biopsy with antibiotic prophylaxis.

NCT ID: NCT06359821 Not yet recruiting - Clinical trials for Metastatic Prostate Cancer

Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry in Metastatic Castration Resistant Prostate Cancer

Start date: April 9, 2024
Phase: Early Phase 1
Study type: Interventional

A Study to Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry of ZA-001, an Alpha-particle-emitting Radiopharmaceutical, in metastatic castration resistant prostate cancer

NCT ID: NCT06355050 Not yet recruiting - Prostate Cancer Clinical Trials

Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer

ultraHART
Start date: June 30, 2024
Phase:
Study type: Observational

In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered with by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively.

NCT ID: NCT06353386 Not yet recruiting - Clinical trials for Prostatic Neoplasms, Castration-Resistant

Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)

Start date: May 10, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01). The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.

NCT ID: NCT06353321 Not yet recruiting - Prostate Cancer Clinical Trials

Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1

Start date: September 1, 2024
Phase:
Study type: Observational

To qualitatively determine the imaging performance of PET-CT imaging subsystem of the RefleXion X1 System Device in patients undergoing standard-of-care (SOC) [68Ga]-PSMA-11 PET-CT using Illuccix on the same day.

NCT ID: NCT06343038 Not yet recruiting - Clinical trials for Castration-resistant Prostate Cancer

Targeted Radionuclide Therapy in Metastatic Prostate Cancer Using a New PSMA Ligand Radiolabelled With Terbium-161 (161Tb-SibuDAB) - Dose Identification/Escalation Phase Ia/b Study

PROGNOSTICS
Start date: June 2024
Phase: Phase 1
Study type: Interventional

Researchers will test a new treatment for prostate cancer. This treatment uses an antibody tagged with a small amount of radioactive material. Researchers believe the new antibody might work better than those used before. In the first part of the study researchers will compare the new treatment to the old one on prostate cancer patients using very low doses, not strong enough to treat nor to cause strong adverse reactions. Each patient will eventually receive both treatments, but one at a time. The aim of the second part of the study is to find the best dose of the new treatment for patients. This means finding the dose that offers the most benefits with the fewest side effects. The performance of different prostate cancer diagnostic methods is also in scope of the study.

NCT ID: NCT06335914 Not yet recruiting - Clinical trials for Advanced Prostate Cancer

Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future.

NCT ID: NCT06334120 Not yet recruiting - Clinical trials for Metastatic Hormone-sensitive Prostate Cancer

An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea

Start date: September 1, 2024
Phase:
Study type: Observational

This is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). nmCRPC is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mHSPC is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels. This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to prescribe to men with nmCRPC or mHSPC. It works by attaching to the special molecules called androgen receptors (AR) within prostate cells and blocks hormones called androgens from attaching to AR, which helps delay cancer growth. To learn more about the safety of Darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants. During this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors. Each participant will be in this study for 1 year. The whole study will last about 6 years. During this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. At these visits, the doctors will do scans to check the patients' cancer and take blood samples. The patients will answer questions about any medications they are taking and whether they have any adverse events.