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Prostate Cancer clinical trials

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NCT ID: NCT05187949 Not yet recruiting - Prostate Cancer Clinical Trials

Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer

PROSHADE
Start date: July 2022
Phase:
Study type: Observational

In this project, the investigators aim to evaluate the most appropriate design and implementation strategy of a decision-aid to promote shared-decision making in prostate cancer screening.

NCT ID: NCT05060835 Not yet recruiting - Breast Cancer Clinical Trials

ONCOlogy-targeted NLP-powered Federated Hyper-archItecture and Data Sharing Framework for Health Data Reusability

ONCO-FIRE
Start date: June 2023
Phase:
Study type: Observational

ONCO-FIRE proposes to build a novel hyper-architecture and a common data model (CDM) for oncology, as well as a rich, modular toolset enabling significantly increased interoperability, exploitability, use and reuse of diverse, multi-modal health data available in electronic Health Records (EHR) and cancer big data repositories to the benefit of health professionals, healthcare providers and researchers; this will eventually lead to more efficient and cost-effective health care procedures and workflows that support improved care delivery to cancer patients encompassing support for cancer early prediction, diagnosis, and follow-up. The applicability, usefulness and usability of the proposed hyper-architecture, CDM and toolset for oncology and the high exploitability of health data will be demonstrated in diverse data exploitation scenarios related to breast and prostate cancer involving a number of Virtual Assistants (VAs) and advanced services offering to health care professionals (HCPs), hospital administration/healthcare providers and researchers data-driven decision-support and easy navigation across large amounts of cancer-related information. Through the above mentioned outcomes and the (meta)data interoperability achieved, ONCO-FIRE contributes to the exploitation of large volumes, highly heterogeneous (meta)data in EHR and data repositories including imaging data, structured data (e.g. demographics, laboratory, pathological data), as well as diverse formats of unstructured clinical reports and notes (e.g. text, pdf), including (but not limited to) temporal information related to the patient care pathway and genomics data currently "hidden" in unstructured medical reports, and more. Importantly, ONCO-FIRE interconnects, following a federated approach, large, distributed cancer imaging repositories, currently used for AI tools training and validation, with patient registries and EHRs of cancer-related data and supports exploitation of relevant unstructured data through novel Natural Language Processing (NLP) tools. The ultimate goal is to establish a patient-centric, federated multi-source and interoperable data-sharing ecosystem, where healthcare providers, clinical experts, citizens and researchers contribute, access and reuse multimodal health data, thereby making a significant contribution to the creation of the European Health Data Space.

NCT ID: NCT05046782 Not yet recruiting - Prostate Cancer Clinical Trials

Abbreviated Biparametric MRI (RSI + T2WI) for Prostate Cancer Detection: Correlation With Histopathology

Start date: March 31, 2024
Phase: Phase 2
Study type: Interventional

Multiparametric MRI of the prostate (mpMRI) plays an integral role in contemporary prostate cancer management. It involves the acquisition of both anatomical sequences (T1- and T2-weighted images) as well as 'functional' imaging sequences (diffusion weighted imaging (DWI) and dynamic contrast enhanced (DCE) imaging), the latter sequences being those which image water diffusivity and tissue perfusion, respectively. Advantages of mpMRI include ability to risk stratify patients prior to biopsy, enhanced detection of clinically significant cancer and reduced diagnosis of insignificant cancers, the identification of active surveillance candidates and improved local staging for subsequent surgical and radiotherapy planning. However, there are ongoing challenges encountered with prostate mpMRI in terms of patient acceptance, image acquisition technical challenges, interpretive expertise and cost. These challenges have motivated recent investigations employing tailored MRI protocols, i.e. faster and less expensive MR exams that eliminate one or more aspects of current mpMRI technique considered redundant, while retaining the essential imaging parameters needed for equivalent diagnostic interpretation. Among these is non-contrast biparametric MRI, which involves anatomic T2 weighted images along with diffusion weighted images (DWI) as the only retained functional sequence. Both single center studies and meta analyses have demonstrated no added value for DCE compared to the combination of T2WI and DWI, Overall cancer detection rates have been found to be equivalent for bpMRI compared to mpMRI, independent of reader experience, with comparable efficacy to guide cognitive targeted, MRI-targeted and MRI-US fusion guided biopsy. Equivalence between bpMRI and mpMRI for cancer detection has also been corroborated in two recently published meta analyses. Based upon our institution's experience with prostate mpMRI, avoidance of gadolinium and DCE imaging would be associated with a 30 percent reduction in scan cost and 40 percent reduction in total time (i.e. scan time plus patient preparatory time).

NCT ID: NCT05025527 Not yet recruiting - Prostate Cancer Clinical Trials

Biparametric MRI in Prostate Cancer Screening: a Noninferior Randomized Controlled Study

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

This is a single centre non-inferiority randomized controlled trial in comparison of the bpMRI between the traditional pathway in prostate cancer screening

NCT ID: NCT04993508 Not yet recruiting - Prostate Cancer Clinical Trials

Randomized Prospective Multi Center Cohort Study for Primary Diagnosis of Clinically Significant Prostate Cancer With Combination of PSA/DRE and Multi Parametric Magnetic Resonance Imaging

PRIMA
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This randomized prospective multi center study is designed to confirm a new diagnostic pathway in primary diagnosis of clinically significant prostate cancer by combination of serum levels of prostate specific antigen (PSA), digitorectal examination (DRE), and multiparametric magnetic resonance imaging (mpMRI). Men at the age of 50 to 75 with an elevated PSA (>= 4 ng/ml) and /or suspicious DRE receive an upfront multi parametric MRI. Only men with MRI results suspicious of clinically significant prostate cancer will be biopsied. Those will be randomized into arm A and arm B. Arm A undergoes only targeted MRI/US fusion-guided biopsies (= TB with a maximum of 3 targets and 2 cores per target). Arm B receives systematic biopsies (= SB with 12 biopsy cores) and TB. Men with normal mpMRI will be observed in a structured manner but will not be biopsied (arms C and D). The primary objective comprises the demonstration of non-inferiority of the detection clinically significant prostate cancer (ISUP grade group 1) of TB (arm A) compared to TB+SB (arm B). Overall, our study aims to improve patient care by reducing the number of patients biopsied, by reducing the number of biopsy cores per patient, and by lowering the risk of overdiagnosis of indolent prostate cancer. The results of this study will directly influence clinical practice, will have a positive impact on patients' lives, and will lower the financial burden due to reduced overdiagnosis and over treatment.

NCT ID: NCT04953351 Not yet recruiting - Prostate Cancer Clinical Trials

MRI-Ultrasound Fusion or Cognitive Registration in MR-targeted Prostate Biopsy

PROMUC
Start date: August 2021
Phase: N/A
Study type: Interventional

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-ultrasound fusion targeted biopsy compared to cognitive registration targeted biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.

NCT ID: NCT04889742 Not yet recruiting - Prostate Cancer Clinical Trials

Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

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

This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.

NCT ID: NCT04783636 Not yet recruiting - Prostate Cancer Clinical Trials

To Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers

Start date: March 11, 2021
Phase: Phase 1
Study type: Interventional

The purpose of study is to compare the safety and pharmacokinetics of PT105 with PT105R in healthy postmenopausal female volunteers

NCT ID: NCT04775602 Not yet recruiting - Prostate Cancer Clinical Trials

Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients With Prostate Cancer.

F-PSMA
Start date: May 2021
Phase: Phase 2
Study type: Interventional

Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.

NCT ID: NCT04736108 Not yet recruiting - Prostate Cancer Clinical Trials

Neoadjuvant Therapy of Abiraterone Plus ADT for Intraductal Carcinoma of the Prostate

Start date: May 2021
Phase: Phase 2
Study type: Interventional

Neoadjuvant treatment before radical prostatectomy has been proven to provide benefits on peri-operation results, especially on reduction of tumor volume and minimization of biochemical recurrence. This study will evaluate the efficacy and safety of abiraterone acetate Plus androgen deprivation therapy(ADT)in high-risk localized prostate cancer with intraductal carcinoma of the prostate(IDC-P).