View clinical trials related to Prostatic Neoplasms.
Filter by:The study is an open label, multi-centre, randomized phase III study. The patients will be randomised in a 1:1 ratio to treatment consisting of - Arm A: MD-SBRT in addition to standard treatment - Arm B: Standard treatment Study population: Patients with hormone sensitive prostate cancer (HSPC) with oligometastatic disease detected by PSMA-PET/DT. This includes patients with de novo oligometastatic HSPC and recurrent HSPC after primary RT or prostatectomy. Primary endpoint: Failure free survival Secondary endpoints: - Predictive value of investigated biomarkers in blood and imaging - Acute and late toxicity after MD-SBRT - PROM at 3 months, 1, 3 and 5 years - Castration resistant prostate cancer, CRPC - Overall survival - Differences in outcome between patients by strata Stratification: To avoid imbalance between treatment arms the minimisation method will be used to achieve balance between de novo oligo-metastatic and oligo-recurrent patients, as well as treatment site. Safety evaluation: Adverse events and side effects graded according to CTCAE v5.0 will be collected every 6th month. Serious Adverse Events are to be reported within 24 hours throughout the study duration. Statistical methods: Survival endpoints will be calculated using the Kaplan-Meier method with differences compared using the stratified log-rank test. Randomization time is set as baseline time. Pre-planned subgroup analysis will occur based on pre-specified stratification variables. A Cox multivariable regression model will be used to determine factors predictive of survival. Safety analysis will be performed with Mann-Whitney U-test or Fishers exact test. Criteria for evaluation: Per protocol (patients that have started study treatment) and Intention to treat (all included patients). Planned sample size: 118 patients Analysis plan: The primary end point will be analysed after pre-specified number of events have occurred. All patients randomised to SBRT will be followed minimum 60 months for toxicity. Safety analysis of acute toxicity will take place after median follow up of 6 months. Safety analysis of late toxicity will be analysed after study closure. Duration of the study: Three to five years inclusion. 72 months of follow-up after randomization of the last patient.
Prostate biopsy is the definitive test to establish the diagnosis of prostate cancer. The standard of care biopsy needles do not predictably obtain full cores of tissue and what tissue obtained is often fragmented, making pathologic review a challenge. The VMCore Biopsy System has a geometry in the tip of its biopsy needles that capture more tissue in a single sample. This study is to compare the characteristics of tissue captured by either standard of care needles and the VMCore needle.
This phase III trial compares the effects of robot-assisted radical prostatectomy (RARP) with or without vesicopexy on urinary continence (a person's ability to control their bladder) and quality of life in patients with cancer of the prostate. RARP is the most adopted surgical approach for treatment of prostate cancer that has not spread to other places in the body (non-metastatic). Urinary incontinence (inability to control the bladder) is one of the most common complications of RARP, impacting patients' quality of life and psychological well-being. Different techniques have been proposed to improve urinary continence following RARP. Vesicopexy is one technique that restores the bladder to its normal position in the body after RARP. This study aims to evaluate whether RARP with vesicopexy may improve urinary continence and quality of life after surgery in prostate cancer patients.
The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools.
This is a single-centre prospective, non-randomized trial to investigate the efficacy of cryotherapy in patients with localized prostate cancer.The aim of study is to investigate the safety profile of cryotherapy in the treatment of prostate cancer and to evaluate the oncological control of prostate cancer by means of cryotherapy focal treatment.
Efficacy of 68Ga PSMA PET / CT in the diagnosis of lymph node metastasis in patients with prostate cancer: a single center prospective randomized controlled trial. To identify and compare the diagnostic efficacy of 68Ga-PSMA PET/CT and mpMRI for lymph nodes in patients with newly diagnosed prostate cancer.
This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of prostate cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors.
Primary objective: i.The primary objective is to compare the diagnostic positivity in progression of 68Ga-PSMA PET and Bone scan. Secondary objectives: i.The correlation between PET osseous tumor burden index and Alk-P level ii.The correlation between PET osseous tumor burden index and PSA level
This phase II trial studies the effect of androgen ablation therapy with or without niraparib after standard of care radiation therapy in treating patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread to nearby tissue or lymph nodes (locally advanced). Androgen ablation therapy (also known as hormone therapy) lowers the levels of male hormones called androgens in the body. Androgens stimulate prostate cancer cells to grow. There are 2 types of androgen ablation therapy given in this study: AAP + ADT and Apa + ADT. AAP + ADT is the treatment combination of the drugs abiraterone acetate and prednisone (AAP) given with androgen deprivation therapy (ADT, also known as androgen deprivation therapy or androgen suppression medication, which is used as standard of care to lower testosterone levels in men with high risk localized or metastatic prostate cancer). Apa + ADT is the treatment combination of the drug apalutamide (Apa) given with ADT. Androgen ablation therapy with or without niraparib after radiation therapy may help to control the disease in patients with prostate cancer.
This is a phase I/II study investigating the combination of 225Ac-J591 (a drug that can deliver radiation to prostate cancer cells) with pembrolizumab (immunotherapy, a drug that increases the immune system's ability to destroy cancer cells). This study will assess whether 225Ac-J591 + pembrolizumab + androgen receptor pathway inhibitor (ARPI) is more effective against prostate cancer than pembrolizumab + ARPI alone.