A Prospective, Multi-arm, Multi-center Clinical Trial on Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer
This is a prospective, multicenter, multi-arm, non-randomized, open-label clinical trial to evaluate the efficacy and safety of neoadjuvant intense endocrine therapy for high-risk or locally advanced prostate cancer.
NCT05406999 — Neoadjuvant Therapy
Status: Recruiting
http://inclinicaltrials.com/neoadjuvant-therapy/NCT05406999/
A Multi-stage Study to Improve Informed Decision-making for Precision Oncology in Veterans With Advanced Prostate Cancer
This clinical trial explores and implements methods to improve informed decision making (IDM) regarding precision oncology tests amongst veterans with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Precision oncology, the use of germline genetic testing and tumor-based molecular assays to inform cancer care, has become an important aspect of evidence-based care for men with advanced prostate cancer. Veterans with metastatic castrate-resistant prostate cancer may not be carrying out IDM due to unmet decisional needs. An informed decision is a choice based on complete and accurate information. The information gained from this study will help researchers develop a decision support intervention (DSI) and implement the intervention. A DSI may serve as a valuable tool to reduce ongoing racial disparities in genetic testing and encourage enrollment to precision oncology trials.
NCT05396872 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05396872/
An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum
In Europe, prostate cancer (PCa) is the second most frequent type of cancer in men and the third most lethal. Current clinical practices, often leading to overdiagnosis and overtreatment of indolent tumors, suffer from lack of precision calling for advanced AI models to go beyond SoA by deciphering non-intuitive, high-level medical image patterns and increase performance in discriminating indolent from aggressive disease, early predicting recurrence and detecting metastases or predicting effectiveness of therapies. To date efforts are fragmented, based on single-institution, size-limited and vendorspecific datasets while available PCa public datasets (e.g. US TCIA) are only few hundred cases making model generalizability impossible. The ProCAncer-I project brings together 20 partners, including PCa centers of reference, world leaders in AI and innovative SMEs, with recognized expertise in their respective domains, with the objective to design, develop and sustain a cloud based, secure European Image Infrastructure with tools and services for data handling. The platform hosts the largest collection of PCa multi-parametric (mp)MRI, anonymized image data worldwide (>17,000 cases), based on data donorship, in line with EU legislation (GDPR). Robust AI models are developed, based on novel ensemble learning methodologies, leading to vendor-specific and -neutral AI models for addressing 8 PCa clinical scenarios. To accelerate clinical translation of PCa AI models, we focus on improving the trust of the solutions with respect to fairness, safety, explainability and reproducibility. Metrics to monitor model performance and a causal explainability functionality are developed to further increase clinical trust and inform on possible failures and errors. A roadmap for AI models certification is defined, interacting with regulatory authorities, thus contributing to a European regulatory roadmap for validating the effectiveness of AI-based models for clinical decision making.
NCT05384002 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05384002/
Outcome Of Treatment Of Prostate Cancer at Sohag University Hospital Between 2017 to 2021
Worldwide, prostate cancer is the most commonly diagnosed male cancer and the fourth leading cause of cancer death in men. Risk stratification is according to cancer stage, Gleason score, and PSA level . Definitive treatment of localized disease ( low and favorable intermediate risk) includes watchful waiting , active surveillance , radiation therapy , radical prostatectomy and cryotherapy .Primary treatment of unfavorable intermediate risk , high risk localized disease and locally advanced prostate cancer , includes both radical prostatectomy (RP) and EBRT + long-term androgen deprivation therapy (ADT) .Treatment options of metastatic prostate cancer include pain medications, bisphosphonates, hormonal treatment, chemotherapy, radiotherapy, immunotherapy, focused radiation, and other targeted therapies .
NCT05382182 — Prostate Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05382182/
Prospective Evaluation of Patient Preferences for Outcomes of Hormonal Agents and Chemotherapy in Combination With Androgen Deprivation Therapy
The purpose of this study is to quantify and publish participants' relative preferences for outcomes of chemotherapy and novel oral hormonal agents when added to androgen deprivation therapy (ADT) for participants with locally-advanced and metastatic hormone-sensitive prostate cancer (mHSPC). This study will also quantify the importance of administration factors related to convenience relative to treatment outcomes.
NCT05381311 — Prostate Cancer
Status: Completed
http://inclinicaltrials.com/prostate-cancer/NCT05381311/
An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum
Currently, in the clinical landscape of PCa, much of the AI work is limited to single-centre, single AI-architecture analyses and critically, on small data sets. ProCAncer-I will create a vast, diversified and multidisciplinary repository, fed by a large collection of mp-MRI. The participating clinical partners will congregate mp-MRI and clinical data, retrospectively and prospectively, from more than 17.000 PCa patients (11.000 retrospective and 6.000 prospective mp-MRI cases), including baseline examinations and follow up studies to form the ProstateNET dataset, counting more than 1.5 million image representations of the prostate (cancerous, non-cancerous and benign cases). ProCAncer-I aims to address the unmet clinical needs in PCa regarding precision diagnosis and personalised disease management with a disruptive paradigm change in clinical research, exploiting a novel multi centre collaboration, comprising a master-global model, boosted with MRI and AI modelling methodology. ProCAncer-I will deal with both retrospective and prospective data. Retrospective data will be collected and will be used to implement and train AI algorithms by other partners of the Consortium. Similarly, prospective data will be collected for the development of vendor specific models and external validation of AI models.
NCT05380518 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05380518/
A Prospective Clinical Study of the Safety and Efficacy of Pamiparib Combined With Abiraterone Acetate in Neoadjuvant Treatment of High-risk or Very High-risk Localized Prostate Cancer
To evaluate the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy
NCT05376722 — Neoadjuvant Therapy
Status: Recruiting
http://inclinicaltrials.com/neoadjuvant-therapy/NCT05376722/
Angelica Herbal Supplement AGN-CognI.Q Acute Dose Safety and Pharmacokinetics (PK) Dose-Response in Prostate Cancer Patients (PK Dose Trial)
This study is to obtain acute dose safety and pharmacokinetics/pharmacodynamics (PK/PD) data in a dose-response trial in prostate cancer patients.
NCT05375539 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05375539/
Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer
Prostate cancer is the most frequent malignancy in the male population of developed countries and has a substantial socio-economic impact. Focal therapies, including focal laser ablation (FLA), are gaining ground as a novel strategy to treat organ-confined low- to intermediate risk PCa while preserving healthy tissue and reduce treatment-related morbidity associated with radical treatments. This project has the goal to perform a feasibility study on magnetic resonance imaging (MRI)-guided focal laser ablation using the TRANBERG®|Thermoguide Therapy System including TRANBERG®Thermoguide Workstation for MR thermometry developed by the company CLS AB.
NCT05370482 — Prostate Neoplams, Magnetic Resonance Imaging, Laser Ablation
Status: Recruiting
http://inclinicaltrials.com/prostate-neoplams-magnetic-resonance-imaging-laser-ablation/NCT05370482/
MR-guided Tumour Boost With Stereotactic Body Radiotherapy in Prostate Cancer
This is a single-arm feasibility study that is recruiting 40 patients with histologically-proven localized prostate cancer and MRI-defined lesion(s). Participants in this study will get MR-guided radiotherapy boost to MRI visible tumour before or after whole gland radiation. Participants will be followed-up as per standard of care schedule up to 5 years post-treatment.
NCT05364229 — Prostate Cancer
Status: Recruiting
http://inclinicaltrials.com/prostate-cancer/NCT05364229/