View clinical trials related to Prostate Cancer.
Filter by:This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion.
Nowadays robot-assisted radical prostatectomy (RARP) has become the standard surgical treatment for localised prostate cancer. The robotic approach has been proven superior to open retropubic prostatectomy (ORP) in terms of surgical-related morbidity: RARP has in fact been associated with significantly lower estimated blood loos (EBL), lower transfusion rate, less length of stay, shorter catheterization time, lower risk of Clavien-Dindo grade II and III complications, lower risk of vesicourethral anastomotic stricture and less post-operative pain. The optimal anatomical visualisation and the extraordinary maneuverability, along with the tamponade effect of the pneumoperitoneum, are surely to be deemed responsible of this statistically significant differences. However, to this day no study has ever investigated the prognostic significance of haematological parameters in terms of predicting perioperative bleeding risk in patients undergoing RARP. Therefore, the investigators conducted a retrospective non-interventional cohort study to gather evidence concerning the impact of anemia and thrombocytopenia on bleeding risk following this surgical procedure. Furthermore, the investigators evaluated associations between demographical, pathological and surgical factors and hemorrhagic complications. The investigators retrospectively evaluated all the patients that underwent robot-assisted radical prostatectomy in our Urology Unit from the 1st of January 2017 to the 31th of December 2020. The investigators collected demographic, clinical and pathological data from the medical records of these patients, with particular attention to other known risk-factors for RARP-associated bleeding (e.g.: volume of the prostate, body mass index, smoking status, nerve sparing technique). Complications were analyzed according to the Clavien- Dindo classification. Bleeding was assessed by considering both the hemoglobin (Hb) drop after surgery and the fluid intraoperatively collected in the suction canister, with all the due adjustments. Moreover, post-operative haemorrhagic complications were evaluated. The investigators included patients not younger than 18 years old, of which records of a pre-operative full blood count in the 30 days prior to the surgery along with a full blood count the day after were available. Criteria for exclusion were a history of congenital coagulopathies and/or congenital thrombocytopenia and patients that underwent salvage radical prostatectomy after radiation therapy. Statistics: EBL and operative time learning curve is studied. Clinical, pathological, intraoperative risk factors analysis for higher EBL is performed by linear regression modelling. Factors are evaluated independently and jointly. Association between each factor above and post-operative outcomes (i.e. post-op bleeding, need of transfusion and hematuria) is also assessed.
This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) . The aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard.
This is a single center, blinded (the mpMRI will be read by expert personnel not aware of the patient's diagnosis ), retrospective study. A total of 200 patients with suspicious prostate cancer (PCa) who underwent, between January 2014 and January 2022, mpMRI of the prostate and subsequent prostate biopsy will identified. All mpMRI images will be retrospectively collected and evaluated using the Quantib Prostate software. In particular, 200 mpMRI with endorectal coil will be read by the expert radiologist and by the Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software, thus evaluating the predictive characteristics of Quantib Prostate for the identification of suspicious lesions. The sensitivity, specificity, negative predictive value, positive predictive value and accuracy of Quantib Prostate vs. radiologist in detecting csPCa will be evaluated using the biopsy report as reference standard.
The purpose of this study is to evaluate if a VR headset and/or aromatherapy can be used to reduce patient pain, anxiety, and embarrassment during a transperineal biopsy (TPBx) compared to standard of care (SOC). The primary objective is to evaluate differences in self-reported pain, fear, or embarrassment during and after the procedure between the VR Group, Aromatherapy Group, VR+Aromatherapy Group, and the Control group.
Evaluate the protein expression of lactate dehydrogenase enzyme (LDHA) and MCT-1/-4 transporters, involved in lactate synthesis and transport, in prostate carcinoma tissues from severely overweight/obese (BMI > 27.5) and non-severely overweight/normoweight (BMI < 27.5) patients affected by prostate carcinoma. ii. Characterize the immune infiltrate in the prostate carcinoma of the aforementioned patients. iii. Assess the association between intra-tumoral lactate accumulation (using LDHA and MCT-4 protein expression levels as readouts) and alterations in the tumor immune microenvironment and/or deregulation of relevant oncogenic pathways.
Trial design: A single centre phase II non-randomised study Trial population: Men with intermediate risk localised prostate cancer Recruitment target: 20 patients in total Trial objectives: - Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects - Secondary - To assess levels of acute GU and GI toxicity (CTCAE) - To assess levels of late GU and GI toxicity (CTCAE) - To assess late sexual quality of life (expanded EPIC, IIEF-5) - To assess biochemical relapse-free survival at 2 years Trial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.
This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. Novel radiotracers and a genomic classifier (Decipher) will be used to guide treatment decisions, instead of standard imaging which is limited by lower sensitivity and specificity. The hypothesis for the study is that treatment intensification based on a positive PSMA PET/ CT scan or Decipher high score (> 0.6) improves time to new metastases detected on PSMA PET/ CT in high-risk PCa. In patients who are PSMA PET/ CT negative with a low/ intermediate Decipher score (≤ 0.6), it is hypothesized that treatment de-intensification will improve patient quality of life while maintaining a good oncological outcome. The study will be conducted at multiple centers across Europe. Participation in the study will comprise a screening period, where the screening assessments must be completed before subjects are enrolled and randomized (only for Phase 3 subjects). Eligible, consenting subjects will then undergo treatment according to their assigned study phase and treatment group, to occur over up to 96 weeks (24 months) with a post-treatment follow-up period to monitor safety and efficacy. The study will be closed when 96 events have been registered for the primary endpoint, which is expected to be at 7-8 years from the time of randomization of the first subject.
The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI (MRI pathway).
The goal of this intervention study is for patients on active surveillance for prostate cancer, to demonstrate that use of regular MRI scans is better able to detect cancer progression over 5 years compared to the current NICE defined strategy. Research Question P - In patients who are on active surveillance for low to medium risk prostate cancer, I - is the use of regular MRI scans C - compared to current NICE defined standard of care, O - better at detecting cancer progression with less cost to the NHS (fewer PSA tests, biopsies and clinic visits)? Patients will be allocated in a 1.1 ratio to either MRI scans or the current NICE defined standard. Randomisation will be blocked (random block size) and stratified by MRI visibility of lesions (3 categories [ no visible lesion, diffuse changes, discrete visible lesion]), cancer Grade Group (GG1, GG2) and time since diagnosis. This study will not be blinded to patients or physicians.