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Prostatic Neoplasms clinical trials

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NCT ID: NCT05169372 Terminated - Prostate Cancer Clinical Trials

Retrospective Analysis of 68Ga-PSMA-PET in Patients With Prostate Cancer: Experience From Brazil

PET-PSMA
Start date: May 11, 2022
Phase:
Study type: Observational

Gallium-68-prostate-specific membrane antigen (68Ga-PSMA) positron emission tomography (PET) has been increasingly used in the management of PCa in Brazil. Thus, the detection of metastatic lesions is improved over traditional methods e.g. MRI and the diagnosis of mCSPC patients has been proportionally increasing. Due to a lack of guidelines and clinical trials including 68Ga-PSMA-PET imaging, the management of these patients is extrapolated from data based on conventional imaging. Treatment decision and duration of treatment for mCSPC patients based on 68Ga-PSMA-PET imaging is currently unknown. 68Ga-PSMA-PET allows a diagnosis of a different set of low volume oligo-metastatic prostate cancer patients. Based on that, a new gap has been built up, since there are no standards of how those patients are managed and how they respond to conventional therapies, to metastasis direct therapy or even if they could be spared of any treatment, reducing costs and toxicities. This patient population has not been included in clinical trials and its critical to generate information on the diagnosis, treatment and outcome of these patients in clinical practice.

NCT ID: NCT05124795 Terminated - Clinical trials for Metastatic Castration Resistant Prostate Cancer

IMU-935 in Patients With Progressive, Metastatic Castration Resistant Prostate Cancer

Start date: December 9, 2021
Phase: Phase 1
Study type: Interventional

Dose escalation study to evaluate the safety, tolerability and anti-tumor activity of single agent IMU-935 in patients with progressive, metastatic castration resistant prostate cancer (mCRPC).

NCT ID: NCT05010759 Terminated - Prostate Cancer Clinical Trials

Study of Focal Ablation of the Prostate With NanoTherm® Therapy System for Intermediate-Risk Prostate Cancer

Start date: November 30, 2021
Phase: N/A
Study type: Interventional

Stage 2B: NanoTherm ablation of focal prostate cancer in small lesions in Gleason 3+4 disease. The outcome of this ablation is validated by a transperineal biopsy at 4 months after ablation.

NCT ID: NCT04957290 Terminated - Clinical trials for Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

A Study of NOX66 and External Beam Radiotherapy in Patients With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors

Start date: October 25, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1b/Phase 2a, open-label, multicenter study to determine the safety, tolerability, recommended Phase 2 dose (RP2D), efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) properties of idronoxil when rectally administered as a suppository (NOX66) to patients with any solid tumor (Part 1) and patients with metastatic castration-resistant prostate cancer (mCRPC), breast cancer (BC) and non-small-cell lung cancer (NSCLC) (Part 2) who are eligible for low-dose external beam radiotherapy (EBRT) for at least one symptomatic or minimally symptomatic lesion (for the prevention of symptoms).

NCT ID: NCT04951492 Terminated - Clinical trials for Prostate Adenocarcinoma

Olaparib for the Treatment of Castration Resistant Prostate Adenocarcinoma

Start date: November 9, 2022
Phase: Phase 2
Study type: Interventional

This phase II trial investigates the effect of olaparib in treating patients with castration resistant prostate adenocarcinoma. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT04928820 Terminated - Clinical trials for Metastatic Prostate Carcinoma

68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy

Start date: June 16, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.

NCT ID: NCT04927559 Terminated - Clinical trials for Anatomic Stage III Breast Cancer AJCC v8

Health Literacy in Understanding Radiation Therapy Information in Patients Undergoing Definitive Radiation Therapy

Start date: December 18, 2020
Phase:
Study type: Observational

This study assesses the health literacy and understanding of radiation therapy information during consultation in patients with prostate or breast cancer undergoing definitive radiation therapy. Health literacy is defined as "the capacity to obtain, process, and understand health information and services to enable sound health decisions." Information gained from this study, may help researchers develop appropriate modalities to enhance comprehension of radiation therapy, and therefore allow for improved patient decision making with medical treatment.

NCT ID: NCT04907227 Terminated - Prostatic Neoplasms Clinical Trials

Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)-China Extension

Start date: September 23, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of Chinese men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.

NCT ID: NCT04873427 Terminated - Prostate Cancer Clinical Trials

In Situ Clonal Heterogeneity in Prostatic Diagnostic Biopsies

Start date: April 15, 2021
Phase:
Study type: Observational

This is a retrospective, proof of concept study, which aims at reconstructing the cellular heterogeneity of the tumor in multi-needle diagnostic prostate biopsy as well as any biopsy containing potentially pre-malignant tissue, to study its implications in the clinical history of the disease. For each patient, 2 or more samples will be prepared starting from the FFPE diagnostic material. The biopsy used for assigning the Gleason score will be sequenced, together with two or more of the local peri-proximal biopsies with a higher level of differentiation. Samples will undergo Whole Exome Sequencing with an average coverage of 300x at the Wellcome Sanger Institute (WSI, Hinxton, UK). Sequencing data will be analysed for single nucleotide variants, copy number variants and structural variants by using state-of-the-art data analysis pipeline at WSI. 1. Reconstruction of local PCa heterogeneity in multi-needle diagnostic biopsy with different Gleason scores (6-10) using high-coverage whole exome sequencing (WES) and DP-based clonal analysis; 2. Characterization of the relationships between pathological differentiation (Gleason score) and genomics-measured heterogeneity and malignancy features; 3. Assessment of clinical implications of clonal heterogeneity. The study will include an average of 150 prostatic diagnostic biopsies from a cohort of 20 early metastatic PC patients and 20 non-relapsing/non-metastatic patients with indolent malignant disease.

NCT ID: NCT04844749 Terminated - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Efficacy Evaluation of VERU-111 for mCRPC in Patients Who Have Failed at Least One Androgen Receptor Targeting Agent

VERACITY
Start date: June 24, 2021
Phase: Phase 3
Study type: Interventional

To demonstrate the efficacy of VERU-111 (Sabizabulin) in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent as measured by radiographic progression-free survival.