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Prostatic Neoplasms clinical trials

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NCT ID: NCT04108871 Recruiting - Prostate Cancer Clinical Trials

Whether Transperineal Prostate Biopsy Under Local-anaesthesia Using a Transperineal-access System is Non-inferior to Standard Transrectal Biopsy to Detect Prostate Cancer in Biopsy-naïve Men

Start date: October 3, 2018
Phase: N/A
Study type: Interventional

Tranperineal prostate biopsy(TPB) and Transrectal prostate biopsy(TRUSB) are now both routine diagnosis methods of prostate cancer in Queen Mary Hospital. The TRUSB has been the most common way to sample prostate tissue for decades. The TPB has been employed as one of our routine diagnosis methods in early 2018. The aim of this study is to evaluate whether Tranperineal prostate biopsy using a noval transperineal access system under local anaesthesia is non-inferior to standard 12-cores Transrectal prostate biopsy in detecting prostate cancer (PCa), in patients with clinical suspicion of PCa with no prior prostate biopsy.

NCT ID: NCT04105920 Recruiting - Prostate Cancer Clinical Trials

Evaluation of the Interest of Hyaluronic Acid in the Preservation of Sexual Function During Prostate Curietherapies

HYALEREC
Start date: October 5, 2021
Phase: N/A
Study type: Interventional

Prostate cancer is the most common cancer in humans, but low mortality, around 10 / 100,000 patients / year. It differs from other cancers by its high rate of cure, as well as a long term survival. Numerous treatment techniques are available and of comparable effectiveness: as a result it must be given importance to the short and long term side effects of these different treatments. Prostate brachytherapy with permanent implants is thus one of the standard techniques for the treatment of localized prostate cancers of favorable grades (WHO grade 1-2). In comparison with prostatectomy and RTE, brachytherapy allows low rates of long-term urinary toxicities, and comparable rates of erectile function preservation. With regard to erectile dysfunction, their pathophysiology after irradiation is complex and poorly understood, including damage to the erector apparatus, innervation, vascularization, and of course the level of libido. As an example, the radiotherapy team of the Lyon Sud hospital showed that the delivering a the lowest dose of radiation to the pudendal arteries and to the penile bulb during RTE, leads to erectile preservation rates comparable with those from the literature with nearly 85% of patients with erectile function retained at 2 years . They were also able to retrospectively show that a lower dose to the pudendal arteries correlated with better erectile function during brachytherapy. The brachytherapy procedure requires general anesthesia and endorectal ultrasound, which are optimal conditions for injecting hyaluronic acid between the prostate, rectum, and pudendal arteries. This gesture has shown to induce very few morbidity. They want to demonstrate that the injection of hyaluronic acid during prostate brachytherapy will reduce the radiation dose to the pudendal arteries and penile bulb, and thus improve the rate of preservation of erectile function in selected patients. This randomized phase III study comparing dyserection rates after CT performed with (Arm A) and without (Arm B) injection of HA, in a patient population without erectile dysfunction before treatment.

NCT ID: NCT04104893 Recruiting - Clinical trials for Metastatic Castration Resistant Prostate Cancer

A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation

CHOMP
Start date: February 20, 2020
Phase: Phase 2
Study type: Interventional

The primary objective is to assess the activity and efficacy of pembrolizumab, a checkpoint inhibitor, in Veterans with metastatic castration-resistant prostate cancer (mCRPC) characterized by either mismatch repair deficiency (dMMR) or biallelic inactivation of CDK12 (CDK12-/-). The secondary objectives involve determining the frequency with which dMMR and CDK12-/- occur in this patient population, as well as the effects of pembrolizumab on various clinical endpoints (time to PSA progression, maximal PSA response, time to initiation of alternative anti-neoplastic therapy, time to radiographic progression, overall survival, and safety and tolerability). Lastly, the study will compare the pre-treatment and at-progression metastatic tumor biopsies to investigate the molecular correlates of resistance and sensitivity to pembrolizumab via RNA-sequencing, exome-sequencing, selected protein analyses, and multiplexed immunofluorescence.

NCT ID: NCT04104776 Recruiting - Endometrial Cancer Clinical Trials

A Study of CPI-0209 in Patients With Advanced Solid Tumors and Lymphomas

Start date: September 18, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

First-in-human, open-label, sequential dose escalation and expansion study of CPI-0209 in patients with advanced solid tumors and lymphomas. CPI-0209 is a small molecule inhibitor of EZH2.

NCT ID: NCT04104607 Recruiting - Clinical trials for Castration-Resistant Prostatic Cancer

the Bispecific PSMAxCD3 Antibody CC-1 in Patients With Castration Resistant Prostate Carcinoma

PSMAxCD3
Start date: November 15, 2019
Phase: Phase 1
Study type: Interventional

This trial is a first in human (FIH) study in patients with castration resistant metastatic prostate cancer (CRPC) after failure of third-line therapy aiming to evaluate safety and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity developed within DKTK. CC-1 binds to human prostate-specific membrane antigen (PSMA) on prostate cancer cells as well as to tumor vessels of CRPC, thereby allowing for a dual mode of anti-cancer action. CC-1 was developed in a novel format which not only prolongs serum half-life but most importantly reduces off-target T cell activation with expected fewer side effects. Together with preemptive IL-6 receptor (IL-6R) blockade using tocilizumab, this allows for application of effective bsAb doses with expected high anticancer activity. The study comprises two phases. The first phase is a doseescalation phase with concomitant prophylactic application of tocilizumab to evaluate the maximally tolerated dose (MTD) of CC-1. This is followed by a dose-expansion phase (also with prophylactic IL-6R blockade using tocilizumab), as this approach has been shown to be efficient and beneficial for patients. A translational research program comprising, among others, analysis of CC-1 half-life and the induced immune response as well as molecular profiling in liquid biopsies will serve to better define the mode of action of CC-1 and to identify biomarkers for further clinical development.

NCT ID: NCT04104529 Recruiting - Prostate Cancer Clinical Trials

Clinico-biological Database in Patients Treated With Metabolic Radiotherapy in the Nuclear Medicine Department

BCB RIV
Start date: October 28, 2019
Phase: N/A
Study type: Interventional

Development of a prospective clinico-biological database allowing the provision of clinical data and corresponding biological materials to the medical and scientific community.

NCT ID: NCT04102904 Recruiting - Prostate Cancer Clinical Trials

The Prostate Liquid Study (PLiS)

PLiS
Start date: October 1, 2019
Phase:
Study type: Observational

A multi-site study to evaluate the potential use of the ChEC test of seminal fluid as an additional triage test in stratifying patients for further tests.

NCT ID: NCT04100174 Recruiting - Prostate Cancer Clinical Trials

Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy

fBTsRT
Start date: July 1, 2019
Phase: Phase 2
Study type: Interventional

To determine if fBT+sRT is superior to standard care in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL

NCT ID: NCT04086290 Recruiting - Clinical trials for Prostate Cancer Metastatic

National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients

Oligomet_DK
Start date: October 10, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A prospective, open label phase 2 clinical trial assessing safety, complications and feasibility of radical prostatectomy (RARP) plus local stereotactic body radiotherapy (SBRT) to bone metastases in combination with short-term medical castration to a select population of prostate cancer patients with oligometastatic disease.

NCT ID: NCT04083937 Recruiting - Prostate Cancer Clinical Trials

Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

PAROS
Start date: September 12, 2018
Phase: N/A
Study type: Interventional

As the most common male carcinoma, prostate cancer is a major tumor entity in oncology. In addition to definitive radiotherapy, surgical procedure is considered to be an oncologically equivalent therapeutic alternative for non-metastatic malignancies in the primary setting. However, a subsequent radiotherapy of the prostate bed is often necessary, which takes place as an "adjuvant" treatment immediately after surgery or in the course of a repeated increase in PSA and usually extends over several weeks. For the primary situation (without previous surgery), several randomized phase III clinical trials have shown that it is possible to shorten radiotherapy by increasing the single dose (called hypofractionation). In the context of two prospective Phase II studies, which were carried out in Heidelberg, it has since been shown that hypofractionation with both photons and protons is safe and feasible even in the postoperative situation. The current, prospective and randomized PAROS study is now intended to demonstrate a multicentric phase III study as an improvement in the quality of life caused by rectum toxicity (primary endpoint) by the use of protons. The oncological non-inferiority of hypofractionated radiotherapy after surgery is a secondary endpoint.