NeoAdjuvant Theranostic Lutetium Study: The Nautilus Trial
Prostate CancerTo learn if the proposed dose of 177Lu rhPSMA-10.1 is safe. Phase 2 will open if the Phase 1 dose is found to be safe. To learn about the safety and effects of 177Lu rhPSMA-10.1 alone and with androgen deprivation therapy (ADT) on patients with high-risk, localized prostate cancer before they have surgery to remove the disease.
Focal Laser Ablation of Prostate Cancer: A Feasibility Study Using MRI/US Image Fusion for Guidance...
Prostate CancerThis is an open-label feasibility/pilot study to evaluate the safety and feasibility of the FocalPoint System with UnfoldAI. In this study, we intend to use the UnfoldAI software to identify cancer margins and create ablation treatment plans and use the FocalPoint System to deploy and monitor thermal energy in cancerous regions of the prostate. Subjects will be assessed at 1 week, 1 month, and every 3 months until one-year post-FLA treatment(s) to be monitored for adverse events and complete quality-of-life questionnaires.
A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone...
High-Risk Prostate CancerThe purpose of this study is to learn about how an investigational drug intervention completed before doing prostate surgery (specifically, radical prostatectomy with lymph node dissection) may help in treatment of high risk localized prostate cancers that are most resistant to standard treatments. This is a phase II research study. For this study, capivasertib, the study drug, will be taken with intensified androgen deprivation drugs (iADT; abiraterone and leuprolide) prior to radical prostatectomy. This study drug treatment will be evaluated to see if it is effective in shrinking and destroying prostate cancer tumors prior to surgery and to further evaluate its safety prior to prostate cancer surgery.
Contribution of Canine Detection in the Diagnostic Strategy of High-risk Prostate Cancer (Prostate-K9-Detect)...
High-risk Prostate CancerThe sense of smell allows both humans and dogs to carry out a chemo-sensory analysis of their environment. Volatile organic compounds enter the nasal cavities and bind to receptors in the nasal mucosa. Neuroepithelium cells perform chemoelectric transduction of olfactory information. The latter is supported by one of the fibers of the olfactory nerve which crosses the cribriform plate of the ethmoid to arrive in the olfactory bulb of the brain. Incorporating this information can lead to behavioral responses. The dog has a sense of smell 100,000 times more sensitive than humans, it is able to detect one particle among 1 trillion. The use of detection dogs involves learning the behavioral response to an olfactory stimulus. Prostate cancer represents 25% of male cancers, it is the second deadliest cancer in France with 10,000 deaths per year. Diagnosis of prostate cancer requires a Prostate Specific Antigen (PSA) blood test and a digital rectal examination. In the event of an abnormality in one of these parameters, a prostate MRI is indicated, supplemented by prostate biopsies in the event of an abnormal MRI. However, one situation remains open to discussion: what should be done when faced with a normal MRI despite an abnormal PSA level or digital rectal examination? In this situation and according to current recommendations, the practitioner has the choice between performing prostate biopsies, i.e. an invasive procedure with a high risk of being negative, and simple monitoring, this time with the risk of missing the diagnosis of prostate cancer. Several studies have shown the effectiveness of dogs in detecting very specific volatile organic compounds. Can the investigators train them to detect the catabolites of prostate tumours?
Improving Germline Testing in At-Risk Patients With Prostate Cancer
Prostate CancerA quality improvement initiative to improve rates of germline testing among men with prostate cancer through the use of an in-clinic educational session.
High-Risk prostatE Cancer radiatiOn Versus surgERy
Prostate CancerProstate AdenocarcinomaProspective cohort study comparing robot-assisted radical prostatectomy and external beam radiotherapy combined with androgen deprivation therapy for high-risk non-metastatic prostate cancer in terms of health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival and distant metastasis-free survival.
Efficacy of Ra-223 in PSMA PET Optimally Selected Patients
Castration-Resistant Prostate CarcinomaMetastatic Malignant Neoplasm in the Bone1 moreThis phase II trial studies how well prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans (in combination with bone scans) work in selecting patients for Ra-223 radiation therapy that have castration-resistant prostate cancer that has spread from where it first started (primary site) to the bones (bone metastasis). Ra-223 is a type of therapy that emits radiation. Radiation gives off energy which can kill tumor cells and other cells that may support the tumor cells. Ra-223 is given by infusion into the veins, where it is absorbed by the bones. PSMA PET is a type of scan used to detect prostate cancer tumors. PSMA is a radioactive tracer that binds to a specific protein that is found on prostate tumor cells. The PSMA tracer shows the areas on the PET scan where tumor cells are active. A PET scan uses a special camera to detect the energy given off from radioactive tracers (such as PSMA) to make detailed pictures of areas where the tracer accumulates in the body. The PET scan is often combined with a magnetic resonance imaging (MRI) or computed tomography (CT) scan, which helps to map the locations where PSMA has accumulated. PSMA PET scans may be able to select patients that will benefit the most from Ra-223 treatment.
Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk of Prostate Cancer...
Prostate CancerThe goal of this observational study is to conduct an active surveillance without prostate biopsy for patients with low-risk of prostate cancer based on USTC diagnostic model in participant population. The main questions it aims to answer is: • The safety and feasibility of conducting biopsy free active monitoring in patients with low-risk prostate cancer evaluated by the USTC diagnostic model. Participants will need to detect serum PSA every 3 months. Dynamic change of PI-RADS score and biopsy results will be recorded too.
Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
Prostatic NeoplasmsThe main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with darolutamide to participants with prostate cancer that has spread after initial treatment. Participation may last up to 32 months.
To Evaluate LUTS and Complications Between Indwelling Catheter and Temporary Prostatic Stent in...
Lower Urinary Tract SymptomsProstatic Hyperplasia2 moreThe goal of this single-centre prospective randomized clinical trial is to compare the post-operative use of temporary prostatic stent (Group 1) vs indwelling catheter (Group 2) in patients undergoing cryotherapy for targeted therapy of localized prostate cancer, transurethral water vapor energy ablation (REZUM) or transperineal laser ablation of the prostate with EchoLaser™ system for the treatment of benign prostatic hyperplasia (BPH) The main questions are: Difference in quality of life, Lower Urinary Tract Symptoms (scored with IPSS, International Prostate Symptom Score), urinary continence symptoms (scored with International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, ICIQ-UI-SF) and patient satisfaction between indwelling catheter and temporary prostatic stent (Exime®) score with a non-validated questionnaire (Stent/catheter-related urinary symptoms questionnaire) Difference in side effects and complications between indwelling catheter and temporary prostatic stent (Exime®) A total 120 of patients will be enrolled (Group 1: 60; Group 2: 60) with a 1:1 randomization ratio. The follow-up duration will be 6 months.