A Randomized, Pragmatic, Adaptive Trial of Metformin for Glucose Intolerance or Increased Body Mass Index in Prostate Cancer Patients
Metformin is used widely in the treatment of type 2 diabetes. It has off-label indications for use in the prevention of diabetes and in hyperinsulinar obesity. In medical practices, the implementation of metformin for these off-label indications is variable, often at the level of the provider. Multiple retrospective investigations have also shown a clinical benefit in men with prostate cancer who are incidentally treated with metformin. This pragmatic study will test the feasibility of enrolling patients who have glucose intolerance (as defined by HbA1c of 5.7-6.4%) and/or who have increased BMI (BMI greater than or equal to 25 kg/m2) to a randomized pragmatic study of metformin plus lifestyle modification information versus lifestyle modification information only. For purposes of the scope of this project and the study's feasibility, this will be implemented in a group of prostate cancer patients, who may have additional benefits from metformin.
NCT05515978 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05515978/
Automatic Detection in MRI of Prostate Cancer: DAICAP
Prostate cancer is the most common cancer in France and the 3rd most common cancer death in humans. The introduction of pre-biopsy MRI has considerably improved the quality of prostate cancer (PCa) diagnosis by increasing the detection of clinically significant PCa , and by reducing the number of unnecessary biopsies.However the diagnostic performance of Prostate MRI is highly dependent on reader experience that limits the population based delivery of high quality multiparametricMRI (mpMRI) driven PCa diagnosis. The main objective of this study is the development and the test of diagnostic accuracy of an AI algorithm for the detection of cancerous prostatic lesions from mpMRI images. The secondary objective is the development and the test of diagnostic accuracy of an AI algorithm to predict tumor aggressiveness from mpMRI images.
NCT05513820 — Detection and Characterization of Prostate Cancer Based on Artificial Intelligence
Status: Recruiting
http://inclinicaltrials.com/other/NCT05513820/
Safety and Accuracy of Artificial Intelligence-aided Precision MRI Assessment for the Optimization of Prostate Biopsy in Men With Suspicion of Prostate Cancer: a Multicenter Randomized Controlled Trial.
One-fifth of all men will develop clinically significant prostate cancers (CsPC) in their lifetime. An estimated 268,490 new prostate cancer (PCa) cases and 34,500 deaths are expected in the United States during the year 2022, making PCa the second most common cause of cancer-related deaths in men. MRI with the Prostate Imaging Reporting and Data System (PI-RADS) is a current widely used communicative tool for both CsPC detection and guiding targeted prostate biopsy. The high level of expertise required for accurate interpretation and persistent inter-reader variability has limited consistency and it has hindered the widespread adoption of PI-RADS. Artificial intelligence (AI) shows a broad prospect for medical interpretation and triage in various challenging tasks , including the PCa detection and staging with MRI. While rapid technical advances are furthering the application of AI medical imaging, their implementation in clinical practice remains a major hurdle. Besides, the prospect of data-derived AI tool is to assist human experts rather than replace them, and whether AI can match or exceed the human experts is still a matter of debate. Therefore, despite strong potential, there is urgent need for research to better quantify the accuracy, generalizability and clinical applicability before the clinical use of an AI in a real-world clinical setting.
NCT05513638 — the Application of Artificial Intelligence in the Diagnosis of Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/the-application-of-artificial-intelligence-in-the-diagnosis-of-prostate-cancer/NCT05513638/
A Pilot Study Evaluating Safety and Efficacy of Transperineal Focal Irreversible Electroporation (IRE) of Anterior Prostate Cancer in Patients With an Intermediate Risk.
Most prostate cancer treatment research in the last decade has been focused on trying to improve quality of life, while maintaining a high level of cancer control. However, the concept of Focal treatment is proposed as an intermediate option between active surveillance and treatment of the whole prostate. Focal ablation aims to efficiently treat the localized cancer while reducing complications related to standard treatments, including the risks of incontinence and impotence. Focal Irreversible Electroporation (IRE) delivered by NanoKnife System is composed of the NanoKnife Generator and NanoKnife Single Electrode Probes. With IRE, an electrical current is delivered between a pair of probes in a series of pulses. These pulses create irreversible pores in cell membranes and lead to cell death which allow for only the tissue between these probes being destroyed. The aim of this study is to analyze the safety and efficacy of transperineal IRE treatments in intermediate risk anteriorly localized prostate cancer patients.
NCT05512663 — Prostate Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05512663/
A Phase 2 Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer
This is a multicenter, single-arm, two-stage open-label phase 2 study of the combination of cabozantinib + nivolumab in subjects with advanced castration-resistant prostate cancer (CRPC).
NCT05502315 — Metastatic Cancer
Status: Recruiting
http://inclinicaltrials.com/metastatic-cancer/NCT05502315/
Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer
This is a study to evaluate the safety and clinical activity of the combination of olaparib and high-dose IV ascorbate, as second or later line of therapy, in castration resistant prostate cancer patients with no known DNA repair gene mutations (DDRm). In brief, the primary endpoint is PSA50 response , defined by a 50% reduction in PSA from baseline . The secondary endpoints are assessing the PSA doubling time, radiographic and PSA PFS, safety and tolerability as defined by the incidence of grade 3 to 5 toxicities, and measuring overall survival.
NCT05501548 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05501548/
Targeted Cryoablation of Prostate Cancer Lesions: An Investigator-initiated Trial
This clinical trial is to provide a minimally invasive treatment option in which the targeted prostate cancer tissue is killed by cryoablation at extremely low temperatures only in the specific area of cancer "that should be treated for saving of life"; while, leaving a portion of the normal prostate tissue that is not cancerous. It is a treatment, named by "focal therapy" for "clinically localized prostate cancer". As this new treatment is aiming to treat only specific prostatic area of cancer, it is different from the invasive conventional treatment to remove the entire prostate gland. The goal is to achieve both to control of known cancer by treating only the cancerous area and to maintain of QOL (Quality-of-life) by leaving of the other normal prostate tissue and its surrounding organs intact resulting in prevention of urinary-leakage and sexual-dysfunction as the complications.
NCT05500846 — Prostate Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05500846/
MR Fingerprinting of the Prostate - Towards Improved Patient Care With High Speed Quantitative Imaging
The diagnostic pathway for suspected prostate cancer relies greatly on radiological imaging. Establishment of magnetic resonance fingerprinting (MRF) has the potential to significantly improve patient experience and outcomes. MRF is a novel and innovative approach to a long-standing challenge of recording and reconstructing MR image The aim is to conduct a clinical pilot study in which patients will be scanned using the newly refined MRF sequence in addition to the conventional scanning protocols.
NCT05498623 — Prostate Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05498623/
177-Lutetium-PSMA Neoadjuvant to Ablative Radiotherapy for Oligorecurrent Prostate Cancer (Lunar)
This phase II trial tests whether 177-Lutetium-PSMA given before stereotactic body radiotherapy (SBRT) works to improve cancer control rate in patients with 1-5 prostate cancer tumors that have come back after prior treatment (oligorecurrent). Radioactive drugs, such as 177-Lutetium-PSMA, may carry radiation directly to tumor cells and not harm normal cells. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving 177-Lutetium-PSMA before SBRT may make the SBRT more effective.
NCT05496959 — Prostate Adenocarcinoma
Status: Active, not recruiting
http://inclinicaltrials.com/prostate-adenocarcinoma/NCT05496959/
Artificial Intelligence and Radiologists at Prostate Cancer Detection in MRI: The PI-CAI Challenge
The PI-CAI challenge aims to validate the diagnostic performance of artificial intelligence (AI) and radiologists at clinically significant prostate cancer (csPCa) detection/diagnosis in MRI, with respect to histopathology and follow-up (≥ 3 years) as reference. The study hypothesizes that state-of-the-art AI algorithms, trained using thousands of patient exams, are non-inferior to radiologists reading bpMRI. As secondary end-points, it investigates the optimal AI model for csPCa detection/diagnosis, and the effects of dynamic contrast-enhanced imaging and reader experience on diagnostic accuracy and inter-reader variability.
NCT05489341 — Prostate Cancer
Status: Completed
http://inclinicaltrials.com/prostate-cancer/NCT05489341/