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Prostate Cancer clinical trials

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NCT ID: NCT03620786 Enrolling by invitation - Prostate Cancer Clinical Trials

HIFU for Focal Ablation of Prostate Tissue: An Observational Study

Start date: June 26, 2018
Phase:
Study type: Observational

The Sonablate HIFU device was approved by the U.S.FDA for prostate tissue ablation in October, 2015. The purpose of this observational research study is to investigate the localized treatment of prostate cancer using HIFU through clinical data and health-related quality of life (HRQOL) questionnaires.

NCT ID: NCT03511235 Enrolling by invitation - Prostate Cancer Clinical Trials

Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing

URO-009 Low
Start date: March 12, 2018
Phase:
Study type: Observational

Medicare is requesting outcome data on patients who received Prolaris testing and were prescribed active surveillance (AS). In order to ensure appropriate patient care, it is important to understand how this added prognostic information influences the selection and durability of AS and corresponding clinical outcomes. To address this knowledge gap, this study will evaluate how frequently men with low disease-specific mortality (DSM) risk based on Prolaris CCR score and who meet NCCN low-risk criteria initially select AS (AS selection). This study also will assess how long Prolaris-tested men who initially select AS remain on this course before proceeding to definitive treatment (AS durability), and whether AS duration impacts biochemical recurrence (BCR) and metastasis risk in these men. This retrospective, observational and multi-site study will combine patient CCR scores with longitudinal clinical data to address these questions.

NCT ID: NCT03503643 Enrolling by invitation - Prostate Cancer Clinical Trials

Hemi-Gland Cryoablation for Prostate Cancer at UCLA

Start date: September 15, 2017
Phase:
Study type: Observational

This is a prospective data collection of men who are electing to undergo prostate hemi-gland cryoablation. The purpose of this observational research study is to investigate the localized treatment of prostate cancer using hemi-gland cryoablation. UCLA patients undergoing hemi-gland cryoablation are a unique cohort compared to prior research because all patients at UCLA have had a pre-treatment multi-parametric MRI and Ultrasound fusion targeted biopsy; they will be followed in a similar fashion. This results in more precise assessment of a target region of cancer for ablation which may, in turn, result in improved clinical outcomes.

NCT ID: NCT03459820 Enrolling by invitation - Prostate Cancer Clinical Trials

18F-DCFPyL PET/CT in Prostate Cancer

Start date: June 22, 2018
Phase: Phase 3
Study type: Interventional

This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.

NCT ID: NCT03439033 Enrolling by invitation - Prostate Cancer Clinical Trials

Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer

Start date: April 3, 2018
Phase: Phase 2
Study type: Interventional

This is a study primarily comparing Magnetic Resonance Imaging (MRI) alone to Positron Emission Tomography (PET)/MRI using an experimental tracer, 68Ga-PSMA-HBED-CC, among men with prostate cancer or prostatic cancer recurrence/metastasis. It is hypothesized that this comparison will demonstrate that PET using the tracer, 68Ga-PSMA-HBED-CC, is more sensitive than MRI alone. Potential subjects who cannot undergo MRI may undergo PET/CT instead.

NCT ID: NCT03423303 Enrolling by invitation - Prostate Cancer Clinical Trials

A Randomized Trial of Early Detection of Clinically Significant Prostate Cancer (ProScreen)

ProScreen
Start date: April 23, 2018
Phase: N/A
Study type: Interventional

A population-based randomised trial of prostate cancer screening will be carried out. A total of approximately 67,000 men aged 50-63 in Helsinki and Tampere are randomised to intervention (screening) or control arm. A reduction in harms of screening in the form of overdiagnosis is sought, while retaining as much as possible of the mortality benefit (reduction in prostate cancer mortality). Novel methods that have been shown to increase specificity for clinically relevant prostate cancer but never tested in a randomised setting will be employed in screening and diagnostics. The main end-point is prostate cancer mortality at 10 and 15 years of follow-up.

NCT ID: NCT03389451 Enrolling by invitation - Prostate Cancer Clinical Trials

68Ga PSMA PET for Patients With Biochemical Recurrence of Prostate Cancer

Start date: February 16, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker. To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

NCT ID: NCT03388346 Enrolling by invitation - Prostate Cancer Clinical Trials

68Ga PSMA in Preprostatectomy Patients

Start date: February 16, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This study investigates if a new drug (PSMA) makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker. To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

NCT ID: NCT03373006 Enrolling by invitation - Prostate Cancer Clinical Trials

A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Prostate Cancer

Start date: February 27, 2018
Phase: Phase 2
Study type: Interventional

To investigate the utility of fluciclovine F 18 for evaluation for metastatic disease in men undergoing laser focal therapy of prostate cancer and the impact on inclusion for a focal therapy cohort.

NCT ID: NCT03356912 Enrolling by invitation - Prostate Cancer Clinical Trials

CABAzitaxel With or Without Prednisone in Patients With Metastatic CAstration REsistant Prostate Cancer Progressed During or After a Previous Docetaxel-based Chemotherapy

Start date: November 22, 2017
Phase: Phase 2
Study type: Interventional

Patients with metastatic castration resistant prostate cancer (mCRPC) progressed during or after a previous docetaxel-based chemotherapy, for whom cabazitaxel has been scheduled as per clinical practice and label indication. In the "TROPIC" Trial, cabazitaxel, administered concomitantly with prednisone 10 mg daily, showed a significant advantage vs. mitoxantrone in both Overall Survival (OS) and Progression Free Survival (PFS) / radiographic PFS in patients failing docetaxel-based chemotherapy. Similar to docetaxel, cabazitaxel has been approved in combination with daily prednisone, but the benefits of adding daily corticosteroids to taxane chemotherapy remain to be proven. In fact, corticosteroids have a variety of biological effects, and a number of studies in large cohorts of patients show that they may have both favourable effects, mediated by adrenal androgen and cytokine suppression, and detrimental effects related to their adverse events associated with their long-term use as well to the potential promiscuous activation of the AR. In fact, prednisone and dexamethasone can activate some AR variants that make tumors sensitive to glucocorticoids even at low concentrations. It has been showed that point mutations of the AR, which appear to cluster in the ligand-binding domain, are rare in therapy naive patients but occur in 15- 45% of patients with castration-resistant disease and can increase AR affinity for a wide range of steroids. On the other hand, insofar as safety is concerned, omitting daily corticosteroids does not seem to increase toxicity (e.g. hypersensitivity reactions). In fact, in the CHARTEED trial, docetaxel was safely administered without daily corticosteroids. Safety data about the use of cabazitaxel without daily prednisone/prednisone alone are missing. The CABACARE study is designed to assess the effects in terms of efficacy, safety as well as quality of life of omitting daily corticosteroids in patients treated with cabazitaxel. Furthermore, the CABACARE study evaluates the mutational status of the RB gene as well as presence of AR-V7 variant. The AR-V7 status assessed in circulating tumor cells has a strong predictive value for abiraterone/enzalutamide effectiveness, but its role in patients receiving cabazitaxel requires to be defined.