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Prostatic Neoplasms clinical trials

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NCT ID: NCT05346848 Recruiting - Prostate Cancer Clinical Trials

Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer

DARIUS
Start date: February 24, 2023
Phase: Phase 2
Study type: Interventional

Randomized non-comparative phase II trial to assess the preliminary signs of antitumor activity of darolutamide plus radiation therapy in patients with unfavorable intermediate risk prostate cancer.

NCT ID: NCT05345444 Recruiting - Prostate Cancer Clinical Trials

Radiation Therapy and IRreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)

RTIRE
Start date: May 26, 2022
Phase: N/A
Study type: Interventional

This is a single-site trial for 42 subjects with intermediate risk prostate cancer who undergo Irreversible Electroporation (IRE) followed by Magnetic Resonance guided Radiotherapy MRgRT. The investigators hypothesize that the combined therapy will feasible and be safe to perform with low morbidity. Ultimately, RTIRE may provide optimal treatment for intermediate risk prostate cancer patients.

NCT ID: NCT05344235 Recruiting - Prostate Cancer Clinical Trials

Observational Study on Extreme Hypofractionation for Localized Prostate Cancer

OBELIX PCa
Start date: April 25, 2022
Phase:
Study type: Observational [Patient Registry]

Radiotherapy (RT) is an established treatment option for localized prostate cancer (PCa), with cure rates similar to those of radical prostatectomy. In the last decade, conventionally fractionated RT (1.8-2.0 Gy per fraction to 78-80 Gy) has been replaced by moderately hypofractionated RT (2.3-3.65 Gy per fraction to 56-70 Gy). The rationale behind this change is the scientific level 1 evidence that a higher dose per fraction may improve the cost-benefit of RT due to the specific radiobiology of PCa (a lower alpha/beta than that of adjacent healthy tissues). Additionally, there is a practical advantage both for patients and the radiation department due to a reduced number of fractions. More recently, extreme hypofractionation or stereotactic body radiotherapy (SBRT) (7-9.5 Gy per fraction to 36-43 Gy in 4-7 fractions) has been introduced as RT modality, and proved to be an effective and safe treatment option for patients with low and intermediate clinically-localized PCa, with similar incidence of late toxicity and 5-year disease free survival outcomes when compared to hypofractionated and conventional radiotherapy regimens. International guidelines endorse extreme hypofractionated SBRT as routine treatment option for low and intermediate risk PCa patients. For high-risk prostate cancer, preliminary results of ongoing prospective studies are promising, but these data are not yet mature enough to recommend extreme hypofractionated SBRT in high-risk prostate cancer. Upon this, ongoing prospective trials handle strict eligibility criteria hereby selecting patients with few comorbidities. This may not necessarily fully reflect the real life patient population. Indeed, patients with a large prostate size, a history of transurethral resection of the prostate (TURP), or 'significant' urinary baseline symptoms may be at risk for experiencing increased toxicity. Based on this concern, these patients were excluded from ongoing clinical trials. However, whether these patients will really develop more toxicity, is a theoretical concern, not yet based on clinical evidence. It is our hypothesis that using modern radiotherapy such as volumetric arc therapy (VMAT) and image-guided radiotherapy (IGRT) - both standard technologies at the Radiation-Oncology department in Leuven University Hospitals - extreme hypofractionated SBRT can be successfully implemented in the treatment of intermediate risk and a select group of high-risk PCa patients and/or patients with pre-existing urinary morbidity.

NCT ID: NCT05343936 Recruiting - Prostate Cancer Clinical Trials

Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population

Start date: August 19, 2022
Phase:
Study type: Observational [Patient Registry]

In this study, the investigators aim to form a Brazilian national prospective active surveillance cohort of patients with low-risk prostate cancer in the public health system. The investigators aim to demonstrate data on the pathological reclassification rate, treatment-free survival, among others. This cohort aim to evaluate and validate the active surveillance strategy in Brazil.

NCT ID: NCT05340374 Recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer

LuCAB
Start date: July 14, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial will evaluate the safety of Cabazitaxel in combination with 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer.

NCT ID: NCT05336786 Recruiting - Prostate Carcinoma Clinical Trials

Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

Start date: June 15, 2022
Phase: Phase 3
Study type: Interventional

This phase III trial investigates if perflutren lipid microspheres with ultrasound can be used to diagnose prostate cancer non-invasively. Definity (perflutren lipid microspheres) is an ultrasound contrast agent that is typically used for ultrasound bubble studies that involve the heart. Definity appears on ultrasound images as tiny gas-filled microbubbles. These microbubbles are about the size of a red blood cell and do not stay in a patient's body for more than several minutes, where they are excreted from the lungs and exhaled back into the air when breathing. Definity may enhance ultrasound images of the prostate and help doctors identify prostate cancer on ultrasound images.

NCT ID: NCT05335967 Recruiting - Prostatic Neoplasms Clinical Trials

Effectiveness Evaluation of a Self-management Program for Prostate Cancer Survivors

Start date: May 20, 2022
Phase: N/A
Study type: Interventional

Objectives: This project aims to develop a self-management program for survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy and determine its effectiveness. Methods: The investigators will develop a self-management program and conduct a pilot study on survivors with prostate cancer experiencing urinary incontinence following radical prostatectomy. And the investigators will test the effectiveness of the self-management program. After completing a pretest, participants will be randomly assigned to the experimental or control group. The self-management group will receive the self-management program for 12 weeks, whereas the information group will receive an information package on a healthy diet. Posttests will be administered 12 and 16 weeks after the pretest. The study variables will include physical symptoms and bothers, cancer-related self-efficacy, social participation, demoralization, and resilience.

NCT ID: NCT05334069 Recruiting - Melanoma Clinical Trials

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

Start date: August 1, 2022
Phase:
Study type: Observational

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.

NCT ID: NCT05331638 Recruiting - Prostate Cancer Clinical Trials

Prostate Cancer Genius App Education and Home-based PSA Screening for African American Men

PCGA
Start date: February 24, 2023
Phase: N/A
Study type: Interventional

Prostate cancer is the most diagnosed cancer in African American men and the second-leading cause of cancer-related death. The prostate-specific antigen (PSA) test is an early detection screening measure for prostate cancer. Greater PSA uptake among African Americans may reduce the disproportionate mortality burden of this disease. However, knowledge about prostate cancer and uptake of PSA screening remain low among African American men. To address this inequity, innovative team science approaches are required. This project proposes to develop and test the first-of-its-kind Prostate Cancer Genius App to improve knowledge of prostate cancer risk and symptoms, and deliver tailored navigation to complete a home-based PSA test. The primary goal of this study is to evaluate the feasibility of the Prostate Cancer Genius App in a 30-day pilot randomized control trial compared to an existing app developed by the U.S. Department of Health & Human Services (Prevention Taskforce App). African American men from Oklahoma, aged between 55 and 69 (N = 80), eligible for the PSA test will be randomly assigned 1:1 to receive either app. Three dimensions of app feasibility will be assessed: (1) preliminary efficacy, evaluated via post-intervention differences in prostate cancer knowledge, (2) app engagement and accessibility, measured via self-report questionnaires, and (3) app acceptability, explored via semi-structured qualitative interviews. Finally, the investigative team will explore post-intervention PSA screening rates and identify predictors of screening/not screening across both arms. The successful demonstration of feasibility for the Prostate Cancer Genius App within Oklahoma will support expanding this intervention to African Americans nationwide.

NCT ID: NCT05328505 Recruiting - Prostate Cancer Clinical Trials

Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer

MIDAS-Prostate
Start date: August 5, 2022
Phase: N/A
Study type: Interventional

This is a Phase II prospective sing-arm trial that is recruiting 60 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by PSMA PET. Participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. Participants will be follow-up as per standard of care up to 5 years post-treatment.