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NCT ID: NCT03734757 Recruiting - Prostate Cancer Clinical Trials

Interest of Trimodality PET-CT Choline MRI Before Radiotherapy in High Risk Prostate Cancer

DEMETER
Start date: October 16, 2018
Phase: N/A
Study type: Interventional

The initial staging of locally advanced prostate cancer is made with Computed Tomography scan (CT), Magnetic Resonance Imaging (MRI), and bone scan (BS). For this type of cancer, reference treatment is radiotherapy combined with hormone therapy. The added value of MRI in the delineation of volumes for radiotherapy is known, especially for the definition of extra-prostatic extensions and prostatic apex. However, its regular use is difficult. Indeed, acquisition of Magnetic Resonance Imaging parameters for diagnostic are not adapted to be fused with the planning Computed Tomography. The literature shows that Positron Emission Tomography-Computed Tomography with Fluorocholine is better in terms of diagnostic performance compared to bone scan for bone metastases and to pelvic Magnetic Resonance Imaging for nodal extension. It would therefore improve staging for these patients with a high risk of locoregional and metastatic invasion even if its use is currently not recommended in the initial staging. Thanks to Magnetic Resonance Imaging acquisition parameters adapted to Radiotherapy and additional functional information, an acquisition in tri-modality Positron Emission Tomography/computed Tomography/ Magnetic Resonance Imaging could have an impact on the volumes definition for radiotherapy or even on the therapeutic strategy. The aim of the study is to evaluate the volume modifications obtained on the trimodality evaluation, compared to the standard initial staging (geometric comparison). In addition, it would be a preliminary study for a project using Prostate-specific membrane antigen (PSMA) in trimodality, and / or for a therapeutic interventional study.

NCT ID: NCT03730324 Recruiting - Prostate Cancer Clinical Trials

Predicting Prostate Biopsy Results With Biomarkers and mpMRI.

ProBioM
Start date: November 5, 2018
Phase: N/A
Study type: Interventional

Current standard prostate biopsy techniques, used to definitively diagnose prostate cancer (PC), utilises an ultrasound guided biopsy approach, that offers unsatisfactory specificity and sensitivity for clinical significant PC. This often leads to harmful unnecessary biopsies. To improve the overall detection of clinical significant PC, multiparametric magnetic resonance imaging (mpMRI) has emerged as a new technique that might be useful in selecting the appropriate patient for biopsy. Nevertheless, mpMRI fail to detect cancer in some circumstances and the exact role of mpMRI is undetermined. Currently, the majority of PC is diagnosed either incidentally or by unsystematic screening with prostate specific antigen (PSA). PSA suffers from being an organ specific, but cancer unspecific serum biomarker. PSA testing may neither rule out or confirm the presence of prostate cancer. Newer biomarkers have shown promise in curbing some of this sensitivity and specificity gap, but still needs refinement. In the present study, the investigators will use mpMRI and a new set of urine and plasma biomarkers in combination, prior to performing standard biopsies in order to develop a prediction model for the biopsy outcome. If proven successful the model would offer excellent risk stratification and possibly mitigating the need for biopsies.

NCT ID: NCT03725761 Recruiting - Prostate Cancer Clinical Trials

IMMU-132 in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy

Start date: October 24, 2018
Phase: Phase 2
Study type: Interventional

This study will investigate the safety and efficacy of IMMU-132 in patients with metastatic castration-resistant prostate cancer progressing on abiraterone or enzalutamide.

NCT ID: NCT03724253 Recruiting - Breast Cancer Clinical Trials

[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)

NeoFIND
Start date: July 6, 2018
Phase: Phase 2
Study type: Interventional

To characterize preliminary targeting properties of [68Ga]-NeoBOMB1 in patients with malignancies known to overexpress GRPR.

NCT ID: NCT03706508 Recruiting - Prostate Cancer Clinical Trials

Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy

Start date: August 9, 2013
Phase:
Study type: Observational

Robot-assisted laparoscopic radical prostatectomy (RALRP) is a surgical technique for the treatment of prostate cancer. The aim of this study was to report our initial experience with RALRP, by applying the concept of pentafecta. Pentafecta consists of the five main outcomes in the postoperative period of RALRP: erectile dysfunction, urinary incontinence, postoperative complications, surgical margins and biochemical failure.

NCT ID: NCT03703778 Recruiting - Prostate Cancer Clinical Trials

Real-life Evaluation of the Effect of ADT in Prostate Cancer Patients in Asia (READT Asia Study)

READT
Start date: May 22, 2016
Phase:
Study type: Observational

The prostate gland is a clinically important male accessory sex gland and vital for its production of semen. Prostate cancer (PCa) is now ranked 3th in annual incidence of male cancer and ranked 5th for cancer-related death in men in Hong Kong which accounts for about 10.9 deaths per 100,000 persons. Its incidence is rising rapidly, almost tripled in the past 10 years. Despite the improvement in awareness of the disease and also increasing use of serum prostate specific antigen, many patients still presented at a late stage that beyond cure by local therapy. Together with those patients suffered recurrent disease after local therapy, many PCa patients required the use of androgen deprivation therapy (ADT) for the control of disease. However, unlike other malignancy, PCa is characterized by its slow progression nature and even for metastatic disease the 5-year survival is upto 20%. Therefore, while ADT can provide effective control of disease, there are increasing evidences suggesting that it can also result in many adverse effects in the patients, and these effects are particular important due to the long survival of these patients. From the western literature, the adverse effects can be quite diverse. Classical side effects after ADT include mood changes, hot flushes, change in cognitive function, loss of libido, erectile dysfunction, osteoporosis and pathological fracture, insulin resistance and increase in risk of cardiovascular related mortality. Unfortunately information regarding the side effects of ADT in Asian population is scanty and inconclusive. Therefore, there is a need to have more information on the adverse effect profiles related to ADT in Asian population. This is a multicentre, prospective, observational, non-interventional study to assess the clinical effectiveness, cardiometabolic and skeletal effects of the various type of ADT - bilateral orchidectomy, GnRH agonist, and GnRH antagonist - in men with advanced prostate cancer over a minimum of 1-year observation period.

NCT ID: NCT03694483 Recruiting - Prostate Cancer Clinical Trials

Prostasomes as Diagnostic Tool for Prostate Cancer Detection

Start date: October 3, 2018
Phase:
Study type: Observational

Prostate cancer is the most frequently diagnosed cancer among men over 50 years old in Western societies, with an incidence that is steadily increasing in most countries. The current, most commonly used biomarker for prostate cancer is prostate specific antigen (PSA), which has well known limitations in accuracy and requires additional testing. However, prostate cancer cells secrete exosomes, also known as prostasomes, which are only detectable in the blood of prostate cancer patients. The presence of prostasomes in the blood is in itself a prostate cancer diagnosis. However, the assay that has been designed for the purification of prostasomes requires additional testing for evaluating its robustness and usefulness in the clinical setting. Additionally, the evaluation of the cargo of the purified prostasomes may provide more information on the nature of the prostate cancer, which may help develop a molecular assay for a prostate cancer liquid biopsy rather than a tissue biopsy. Therefore, the purpose of this study is two-fold: a validation phase where the purification of prostasomes will be tested on plasma collected from prostate cancer patients and a molecular testing phase where the contents of the purified prostasomes will be evaluated on their ability to determine the grade of the prostate tumors.

NCT ID: NCT03689582 Recruiting - Prostate Cancer Clinical Trials

Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer

Start date: December 15, 2018
Phase: Phase 2
Study type: Interventional

The purpose of the study is to find out whether imaging of the prostate with a new molecule called 68Ga-PSMA can find prostate cancer. 68Ga-PSMA has been shown in a large number of patients to be useful to find recurring prostate cancer following initial cancer treatment. This study is performed to test 68Ga-PSMA whether it can be used to find prostate cancers that would be considered in need for treatment.

NCT ID: NCT03687918 Recruiting - Prostate Cancer Clinical Trials

External Validation of Prostate MRI QCAD/Lyon

DIJON-CAD
Start date: June 1, 2018
Phase:
Study type: Observational

Multiparametric magnetic resonance imaging (mpMRI) of the prostate combines T2-weighted imaging, diffusion-weighted imaging and dynamic contrast-enhanced imaging. Correlation with radical prostatectomy specimens has demonstrated that mpMRI has excellent sensitivity in detecting prostate cancers (PCa) with a Gleason score ≥7 and cancers with a Gleason 6 and a volume ≥0.5 cc. Nevertheless, its specificity is poor and there is large overlapping between the appearances of benign and malignant prostate lesions. As a result, the use of a 5-point subjective score has been widely encouraged to describe the level of suspicion of prostate lesions. This so-called 'Likert score' is a highly significant predictor of the malignant nature of prostate focal lesions. However, because there are no descriptions of specific criteria to be used in the scoring process, the Likert score relies heavily on the reader's experience. In an attempt to standardize mpMRI interpretation, the European Society of Urogenital Radiology and the American College of Radiology recently endorsed the so-called Prostate Imaging-Reporting and Data System (PIRADS) score. The second version of this scoring system (PI-RADS v2 score) gave good results in characterizing prostate focal lesions. However, Inter-reader agreement remains moderate at best, even after training, and there is still a high-rate of false positives. These results have led some authors to suggest that there might be structural limits to the ability of any score based on MR imaging to allow detection of prostate cancer with high specificity. Using quantitative magnetic resonance (MR) image features to characterize prostate lesions seen on mpMRI could improve interpretation standardization, and recently, several computer-aided diagnosis (CAD) systems combining various image features have shown promising results in characterizing prostate tissues. However, most CAD systems have been trained and evaluated on images from the same MR scanner. Unfortunately, quantification in MR imaging is limited by substantial inter-manufacturer variability in the calculation of quantitative image parameters. The quantitative thresholds defined for one manufacturer may therefore not be valid for another manufacturer. Of the many reported CAD systems, only few have shown robust results at cross-validation in datasets from different manufacturers. We developed in Lyon a mpMRI CAD system for discriminating Gleason ≥7 cancers in the peripheral zone (PZ). That CAD system was trained using mpMRI from patients treated by radical prostatectomy. It combines the 10th percentile of the apparent diffusion coefficient (ADC_10th) and the time to the peak of enhancement (TTP) at dynamic contrast-enhanced (DCE) imaging. It provided good results when cross-validated in two datasets from two different manufacturers (General Electric and Philips). We then tested the CAD on a cohort of 130 patients who underwent mpMRI (General Electric or Philips MR unit) before prostate biopsy. Each MR lesion targeted at biopsy had prospectively received a Likert score of likelihood of malignancy at the time of the biopsy. Retrospective analysis of these MR lesions with the CAD showed that the stand-alone CAD outperformed the Likert score in predicting the presence of Gleason ≥7 cancer at biopsy (Area under the receiver operating characteristic curve (AUC): 0.94 (95% confidence interval (95CI): 0.90-0.98 versus 0.81 (95CI: 0.75-0.88), p<0.0002)). These good results encourage us to perform an external validation of the CAD testing its performance on mpMRI from another manufacturer (Siemens) and another institution. The principal objective of the DIJON-CAD study is to evaluate the performances of the QCAD developed in Lyon (QCAD/Lyon) in a cohort of consecutive patients treated by prostatectomy and who underwent preoperative mpMRI on a Siemens 3 Tesla MR imager at the Dijon University Hospital center or at the Dijon Cancer Center (both institutions share the same MR unit). This study is the first step of the external validation of the QCAD/Lyon system. It is only aimed at verifying that the diagnostic performance of the system is not very poor on external mpMRI (which is a substantial risk). If the results are good, a proper multicentric prospective validation study will be planned.

NCT ID: NCT03682146 Recruiting - Prostate Cancer Clinical Trials

Laparoscopic and Robot-Assisted Radical Prostatectomy - a Comparative Study

LAP-01
Start date: November 2014
Phase: N/A
Study type: Interventional

Men with localized prostate cancer are analyzed. Purpose: This randomized study compares outcomes between robotic-assisted radical prostatectomy and laparoscopic radical prostatectomy