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NCT07189598
The aim of this clinical trial is to evaluate the efficacy of adaptive prostate Stereotatic Body RadioTherapy (SBRT), which integrates both Whole Pelvic RadioTherapy (WPRT) and dose escalation on the Dominant Intraprostatic Lesion (DIL), compared with standard radiotherapy. This will be assessed using a 5-year cost-utility analysis based on data from the clinical trial and the National Health Data System (NHDS).
NCT07393867
This research study is for men with intermediate- or high-risk prostate cancer who are planning to receive hormone therapy and radiation treatment. The purpose of the study is to see whether a special type of diagnostic imaging done during hormone therapy can help doctors more accurately target remaining cancer with radiation, while avoiding areas that may no longer need extra treatment. All participants will receive standard hormone therapy and radiation therapy, along with three imaging scans, over a six-month period. The information gained from this study may help make prostate cancer radiation treatment more precise and reduce side effects for future patients.
NCT07208240
This is a multi-disciplinary collaboration between urologists, oncologists and nuclear medicine physicians from Beilinson hospital at Rabin Medical Center to address the major therapeutic challenge of locally advanced prostate cancer. Our aim is to evaluate the use of a novel treatment (Tb-PSMA) prior to the surgical removal of the prostate. This treatment has already shown initial promising results in patients with metastatic prostate cancer but has never been tested for locally advanced disease before surgery.
NCT06949254
Prostate Cancer (PCa) is the second most common malignancy and the 5th common cause of cancer-related mortality in men worldwide. The majority of patients with PCa is diagnosed with potentially curable disease and its management includes different approaches, such as surgery, Radiation Therapy (RT) and Androgen Deprivation Therapy (ADT), for exclusive use or in combination each other. Randomized clinical trials have shown that moderate hypofractionated RT (i.e., 2.5-4 Gy per fraction) has become a valid alternative to conventionally fractionated RT in patients with PCa. The rationale of hypofractionation is based on the strong radiobiological evidence of the low α/β ratio of PCa cells (1.5-2 Gy) and the greater sensitivity to high dose per fraction. Data suggests that prostate Stereotactic Body Radiation Therapy (SBRT) is an alternative treatment strategy for localized PCa with promising results in terms of disease control and toxicity, not inferior to conventionally fractionated RT. A systematic review of over 6000 men underwent prostate SBRT on prospective studies has demonstrated that this treatment provides favorable patient's quality of life, excellent disease control, and results in minimal serious acute or late toxicity. Almost all the published studies, investigated the role of SBRT for organ-confined low- and intermediate favorable-risk disease. However, the HYPO-RT-PC trial addressed the role of SBRT in the context of unfavorable localized PCa. In this non-inferiority, phase III multicenter trial 1200 patients with either intermediate or high risk PCa were enrolled. The aim of the study was to demonstrate that SBRT (42.7 Gy in 7 fractions, 3 days per week, for 2.5 weeks) is non-inferior to conventional fractionation (78 Gy in 39 fractions, 5 days per week for 8 weeks) regarding failure-free survival, without significant differences in late normal tissues complications. Failure-free survival at 5 years was 84% in both treatment arms; adjusted HR was 1.002, hence ultra-hypofractionation was found to be non-inferior to conventional fractionated RT (given HR limit = 1.338). These results paved the way for the use of SBRT even in patients with unfavorable PCa. One controversial issue is the role of ADT in the setting of SBRT for localized PCa: in conventionally fractionated schedules, short term (4-6 months) and long term (1.5-3 years) ADT are considered the standard of care for unfavorable intermediate and high-risk PCa, respectively. However, in a systematic review/meta-analysis no benefit was found for ADT added to SBRT and similar results were reported also by King et al. in a retrospective study on over 1000 patients. The PACE C trial is one of three cohort of PACE that is multicenter, international phase 3 randomized controlled study. PACE C is set to explore the efficacy of SBRT in combination with ADT for patients with unfavorable intermediate and high-risk PCa and will recruit 1182 patients who will be randomized to receive either hypofractionated RT (60 Gy in 20 fractions) or SBRT delivered with 36.25 Gy in 5 fractions. In this scenario, our study aims to evaluate the safety and efficacy of SBRT (40 Gy in 5 fractions every other day) coupled with ADT (relugolix 18-24 monthsaccording to clinical care) in patients with localized high-risk PCa.
NCT05406999
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.
NCT03537391
Prostate cancer (PC) is the most common cancer among men and one quarter of diagnosed PC are metastatic at the time of diagnosis. Accurate staging is paramount as the stage is the most important factor when treatment decisions are made. The stage is also the single most important prognostic factor. Currently, traditional imaging methods for detection of PC metastasis, including bone scan (BS) and contrast enhanced whole-body computer tomography (CT), are rather inaccurate. Respectively, novel imaging techniques are evolving and novel imaging modalities are emerging in PC diagnostics and staging, but their clinical relevance is unclear and lacking prospective studies comparing traditional imaging with novel imaging. This prospective single-institutional study compares the diagnostic accuracy of novel imaging modalities to traditional imaging modalities aiming to find the most appropriate staging modality in high-risk PC at the time of initial staging.
NCT03340272
The general aim of the study is to describe the use of elective pelvic node irradiation (ENI) in Italy, in patients with intermediate/high/very high-risk prostate cancer patients submitted to adjuvant or radical Radiation Therapy (RT) with or without concomitant Androgen Deprivation hormone Therapy (ADT). The study aims at the definition of survival, toxicity and QoL data in a representative sample of intermediate, high and very high risk prostate cancer patients consecutively recruited in Italian Radiation Oncology Center over two years.
NCT04236752
HDR brachytherapy in conjunction with pelvic SABR in high tier intermediate and high risk prostate cancer patients can provide a safe and effective means of radiotherapy dose escalation. Utilizing multiparametric MRI to focally boost the dominant intraprostatic lesion during HDR brachytherapy is safe and feasible.