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Prostate Cancer clinical trials

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NCT ID: NCT03957252 Not yet recruiting - Prostate Cancer Clinical Trials

Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer

APCaRI-05
Start date: May 2019
Phase:
Study type: Observational

This study is designed to determine the accuracy of blood test ClarityDX Prostate to predict the results of prostate biopsies in men who have PSA (Prostate Specific Antigen) greater than 3 and no higher than 10 ng/mL.

NCT ID: NCT03936127 Not yet recruiting - Prostate Cancer Clinical Trials

Comparison of a Novel Transperineal Targeted Fusion Biopsy System to Conventional Transrectal Targeted Fusion Biopsy

Start date: May 2019
Phase: N/A
Study type: Interventional

This study is designed as a randomized control trial which intends to determine if transperineal (TP) targeted biopsy is not inferior to transrectal (TR) targeted biopsy for diagnosis of clinically significant prostate cancer while comparing post-procedural infection rates between the two techniques. The study will also look to compare patient reported pain scores related to the procedure, rates of other minor complications (e.g. bleeding, urinary retention) and procedure time. The expected sample size at The Ottawa Hospital is 360 men.

NCT ID: NCT03934840 Not yet recruiting - Prostate Cancer Clinical Trials

Phase 2 of Carbo, Taxel and Abi in Metastatic Castration Prostate Cancer

Start date: June 2019
Phase: Phase 2
Study type: Interventional

This is a phase II clinical trial in patients with metastatic castration sensitive prostate cancer. The objective of the study is to determine the efficacy and further define the safety of the treatment combination. This study will evaluate dose levels of carboplatin AUC 4 with cabazitaxel 20 mg/m2. Patients will be treated with the combination of ADT and carboplatin and cabazitaxel for 6 cycles. After 6 cycles of chemotherapy, they will start abiraterone with ADT. The primary objective is to determine the percent of subjects that have no PSA or radiographic progression at 1 year. Secondary objectives will include determining the progressionā€free survival, time to PSA nadir and time to PSA progression of carboplatin and cabazitaxel in combination with ADT.

NCT ID: NCT03927521 Not yet recruiting - Prostate Cancer Clinical Trials

Feasibility Study of PET-MRI/68Ga-PSMA Guidance of Focal Therapy by HIFU in Patients With Prostate Cancer Recurrence After Radiotherapy

PSMA
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

A significant proportion of patients with localized prostate cancer, and treated for curative intent by radiotherapy, have a local recurrence. Among these patients with local recurrence, few receive curative remedial treatment but most of them are treated with palliative hormonal therapy without any chance of long-term recovery. The use of Focused Ultrasound (HIFU) in focal treatment (only on recurrence) is an effective and not very morbid option, especially compared to surgery. The quality of this treatment is conditioned by both an early diagnosis of recurrence, a precise localization of recurrence in the prostate and a rigorous extension assessment for the detection of occult metastases. Innovations in medical imaging have led to the development of a new generation of "hybrid" machines that combine PET (Positron Emission Tomodensitometry) and MRI (Magnetic Resonance Imaging) technology. Associated with the use of 68Gallium-labeled PSMA (Prostate-Specific Membrane Antigen), a new tracer specific for prostate cancer, the investigators believe that this PET-MRI imaging technique can: 1. To identify at an early stage the metastatic patients and to allow a more adapted therapeutic management. 2. A better evaluation of the limits of local recurrence and therefore a more precise definition than with MRI alone of the tumor zone to be destroyed. Finally, the investigators believe that the PET-MRI / 68Ga-PSMA exam, used for the selection of patients eligible for focal HIFU treatment and used for the treatment itself, should allow obtaining an optimal control of the cancer recurrence with the least possible side effects.

NCT ID: NCT03921996 Not yet recruiting - Prostate Cancer Clinical Trials

Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer

Start date: July 1, 2019
Phase: Phase 3
Study type: Interventional

For patients with intermediate-risk prostate cancer plus a predicted risk of >5% for positive lymph nodes and with high-risk prostate cancer, international guidelines recommend ePLND along with the RP. Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. We hypothesize that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.

NCT ID: NCT03920033 Not yet recruiting - Prostate Cancer Clinical Trials

Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy

SHARE
Start date: May 1, 2019
Phase: Phase 3
Study type: Interventional

Patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 Gy, 26 fractions) and a control group of standard treatment group (66 Gy, 33 fractions). The criteria for stratification at randomization include 1) risk groups, 2) androgen deprivation therapy, and 3) PSA before salvage radiation therapy, which affect biochemical recurrence. It is expected that hypofractionated, accelerated high dose radiation therapy will have a superiority in terms of biochemical control to conventional radiation therapy, and the present study would like to confirm this. In addition, we aimed to evaluate and compare the toxicity and quality of life index of two radiation therapy regimens.

NCT ID: NCT03909893 Not yet recruiting - Prostate Cancer Clinical Trials

A Study of Adaptive Radiation Therapy for Pelvic Genitourinary Cancer

ARTGU
Start date: April 2019
Phase: N/A
Study type: Interventional

Radical radiation therapy for prostate cancer is a common treatment that has shown to improve clinical outcomes in a post-operative setting. However, radiation therapy after surgery poses a greater risk for bladder and rectum injury for patients with prostate or bladder cancer. For prostate cancer patients, the risk is further amplified when pelvic nodes are part of the target irradiated volume. For bladder cancer patients, the risk of injury increases when more of the bladder is part of the target volume. Using an adaptive radiation therapy approach allows for correcting any shifts in the target volume. ART approach uses images from treatment to adapt the treatment plan. This study will use Adaptive Radiation Therapy for patients who receive pelvic nodal radiotherapy for either prostate or bladder cancer. Their treatment plans will adapted using MRI scans and CBCT scans taken during their first week of radiotherapy to account for any shifts in the target volume. The purpose of this study is to evaluate the feasibility of ART approach and its and on treatment plan quality metrics for pelvic radiotherapy. Acute and late toxicities will also be evaluated. 40 participants (minimum of 10 bladder cancer patients) will be enrolled. The participants will be followed for a period of 5 years post radiation therapy, during which they will have PSA as per standard practice, along with follow-up questionnaires (EPIC for prostate cancer patients and BUSS for bladder cancer patients).

NCT ID: NCT03896178 Not yet recruiting - Prostate Cancer Clinical Trials

Prostate Cancer in Firemen: Is There a Diagnostic Bias?

Start date: September 1, 2019
Phase:
Study type: Observational [Patient Registry]

Firefighters, police, military personnel and pilots are all shown to have a higher incidence of prostate cancer than the general population. A possible explanation for this is that these four groups of employees need regular mandatory health-checkups. If these checkups increase the chances of having a PSA or DRE performed one could expect the workers in question to have a higher probability than the general population of being diagnosed with prostate cancer. If this is the case the four groups should have cancers that are lower grade and have better survival. The investigators wish to examine this by comparing the four groups with a control group made up of all other workers with regards to prognostic factors at the time of diagnosis and survival rates. This will be done by extracting data from the Cancer Registry of Norway, coupled with employment data from Statistics Norway. This study is also a part of a project on cancer in firefighters. If the prostate cancers in firefighters differ significantly from the other three specified groups, this could point to an exposure specific for firefighters, e.g. fire smoke, as an etiologic factor.

NCT ID: NCT03886493 Not yet recruiting - Prostate Cancer Clinical Trials

Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer

Start date: May 2019
Phase: Phase 2
Study type: Interventional

This is a single-center, single arm, open-label phase II study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant Dupixent given prior to radical prostatectomy.

NCT ID: NCT03878524 Not yet recruiting - Breast Cancer Clinical Trials

A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia

SMMART
Start date: March 14, 2019
Phase: Phase 1
Study type: Interventional

This Phase Ib study assesses feasibility and safety of a personalized medicine approach that utilizes a series of clinical study analytics to characterize the cancer based on DNA mutations, RNA and protein expression, physical and molecular architecture of the cancer tissue, and function of cells. This clinical study analytics will be considered by a tumor board to select therapeutic drug combinations tailored to each individual. The chosen drugs are intended to optimally inhibit and/or perturb biological pathways promoting the growth and/or survival of an individual participant's cancer. Serial biopsies and analytics will allow for the therapy to adapt as the patient's cancer adapts to biological perturbation. The study will include patients with advanced cancer of the breast (BCa), prostate (PCa), or pancreas (PanCa), or those with refractory acute myelogenous leukemia (AML).