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Prostatic Neoplasms clinical trials

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NCT ID: NCT04812366 Recruiting - Prostate Cancer Clinical Trials

Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer

GUNS
Start date: September 21, 2021
Phase: Phase 2
Study type: Interventional

The objective of this study is to see if providing an appropriate therapy based on the genomic testing of prostate tumour tissue will result in an improved clinical response. Each participant will be treated with 8 weeks of a luteinizing hormone-releasing hormone agonist (LHRHa) plus apalutamide (APA) while genome sequence characterization is being done. Participants with biopsy specimens deemed unevaluable for genomic testing will remain on LHRHa plus APA for an additional 16 weeks. Participants with evaluable tissue will be assigned to one of the open-label sub-studies on the basis of genomic profiling results. Within each group, they will be randomized to a specific treatment arm either LHRHa plus APA alone or adding abiraterone acetate and prednisone, docetaxel or niraparib. The study will evaluate the response rate and outcomes after radical prostatectomy in each arm of the trial.

NCT ID: NCT04808427 Recruiting - Prostate Cancer Clinical Trials

Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer

Start date: November 20, 2023
Phase: N/A
Study type: Interventional

Background: The ability to treat early prostate cancer is still limited. Thermal ablation methods are being tested for focal prostate cancer therapy. Researchers want to improve on these methods. Objective: To understand if Transurethral UltraSound Ablation (TULSA) in combination with MRI guidance is useful to treat localized prostate cancer. Eligibility: English-speaking adults ages 18 and older with localized prostate cancer that can be seen on MRI and can be treated by thermal ablation. Design: Participants will be screened with the following: - Medical history - Physical exam - Digital rectal exam - Blood and urine tests - Electrocardiogram - Tumor biopsy - Questionnaire to assess urinary tract symptoms - MRI of the pelvis. The MRI scanner is a long, narrow tube. Participants will lie on a bed that moves in and out of the scanner. Participants may also be screened with the following: - Echocardiogram - Chest x-ray - Bone scan - Urodynamic studies to see how well the bladder, sphincters, and urethra hold and release urine - MRI of the brain - Transrectal ultrasound - Computer tomography (CT) scan of the chest, abdomen, and pelvis. A CT scan is a series of x-ray images taken of parts of the body. Some screening tests will be repeated during the study. Participants will have the TULSA procedure. They will have an MRI for guidance. A small ultrasound applicator will be placed into their urethra. It uses heat to destroy the cancer areas in the prostate. It is controlled by a robotic arm. A cooling catheter will be placed into their rectum. Participants will use a urethral catheter for 1-7 days. Participants will have follow-up visits at 3, 6, 12, 18, 24, and 36 months.

NCT ID: NCT04797039 Recruiting - Clinical trials for Primary Malignant Neoplasm of Prostate (Diagnosis)

MRI-Guided Cryoablation for Focal Native Prostate Cancer

Start date: December 1, 2020
Phase:
Study type: Observational

The purpose of this research is to collect data about the MRI cryoablation procedure your doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after the participants treatment is performed. Participants have been asked to take part in this research because the participants have been diagnosed with prostate cancer and scheduled to have an ablation procedure.

NCT ID: NCT04796467 Recruiting - Prostate Cancer Clinical Trials

68Ga-P16-093 and 68Ga-PSMA-617 PET/CT Imaging in the Same Group of Prostate Cancer Patients

Start date: October 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Prostate-specific membrane antigen (PSMA)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect primary prostate tumor and its metastases, like the widely studied 68Ga-PSMA-617. This pilot study was prospectively designed to evaluate the early dynamic distribution of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 68Ga-PSMA-617 in the same group of prostate cancer patients.

NCT ID: NCT04794777 Recruiting - Prostate Cancer Clinical Trials

Comparing "Salvage" Radiotherapy and Individualized PSMA PET/CT Targeted Treatment in With Relapsing Prostate Cancer

Start date: October 30, 2018
Phase: Phase 3
Study type: Interventional

Less than 50% of patients receiving salvage radiation therapy (SRT) to the pelvis as treatment for prostate cancer relapsing after surgery will achieve undetectable Prostate Specific Antigen (PSA) levels. Despite SRT, two-thirds of patients will again develop elevated PSA, 20% will have distant metastases, and 10% will die from prostate cancer within 10 years. The reason for this is probably preexisting distant metastasis and lymph node metastasises which need to better targeted directly. Additionally , there are well known permanent side effects to SRT. Standard imaging techniques have poor sensitivity detecting recurrence when PSA is below 1.0 ng/ml. The surface protein Prostate-specific membrane antigen (PSMA) is overexpressed on prostate cancer cells and 68Gallium (68Ga)- and 18Fluorine (18F)-targeted radioligands have been developed. PSMA PET/CT is used increasingly but there is limited data of its impact. In this study patients with biochemical relapse of prostate cancer after surgery are randomised to the control or experimental group (1:2) and undergo a PSMA PET/CT scan. The experimental group receives individualised therapy based on the result of the PET/CT. The control group receives standard salvage therapy and the result of the PET/CT is blinded. The patients are followed-up with PSA test and quality of life questionnaires.

NCT ID: NCT04792138 Recruiting - Prostate Cancer Clinical Trials

Learning MRI and Histology Image Mappings for Cancer Diagnosis and Prognosis.

Histo-MRI
Start date: October 23, 2020
Phase:
Study type: Observational

Multiparametric magnetic resonance imaging (mpMRI) is now widely used to risk stratify men with a suspicion of prostate cancer and identify suspicious regions for biopsy. Advanced MRI techniques have emerged which seek to improve this characterisation and could predict biopsy results non-invasively before men undergo biopsy. Before these techniques are translated clinically, robust histological and clinical validation is required. This study aims to clinically validate advanced MRI techniques in a cohort of men suspected with prostate cancer. Histological analysis of men undergoing biopsy, +/- prostatectomy will be used for biological validation of VERDICT; Vascular and Extracellular Restricted Diffusion for Cytometry in Tumours and Luminal Water imaging (LWI). In particular, prostatectomy specimens will be processed using 3-D printed patient-specific moulds to allow for accurate MRI and histology mapping.

NCT ID: NCT04790968 Recruiting - Prostatic Neoplasms Clinical Trials

Combined PSMA PET/MRI for Detection of Lymph Node Metastases in High-risk Prostate Cancer Patients

Start date: April 28, 2021
Phase: N/A
Study type: Interventional

For high-risk prostate cancer patients, detection of lymph node metastases is crucial to ensure optimal treatment. Standard treatment for these patients is radiotherapy or surgery. The surgery involves resection of the prostate and the pelvic lymph nodes. Currently, the most reliable method to confirm lymph node metastases is by histologic examination of the resected lymph nodes. Ideally, one should be able to detect lymph node metastases prior to treatment. Then, the treatment could be better adjusted to each patient. Imaging methods such as prostate specific membrane antigen positron emission tomography (PSMA-PET) can possibly aid the detection of lymph node metastases. In this study, the investigators want to test whether PSMA-PET or a combination of PSMA-PET and MRI (magnetic resonance imaging) can improve staging of lymph nodes before treatment.

NCT ID: NCT04789018 Recruiting - Prostate Carcinoma Clinical Trials

Enhanced Genetic Awareness and Genetic Evaluation for Men Through Technology, ENGAGEMENT Study

Start date: January 21, 2020
Phase:
Study type: Observational

This study assesses perceived usefulness of a web-based virtual prostate cancer genetics board for providers across academic, community, and veteran affairs settings to discuss prostate cancer genetics cases, precision treatment, and screening recommendation. Information gained from interviews and surveys of participants taking part in the virtual genetics board may lend insights into perceived usefulness, perceived ease of use, acceptability, self-efficacy, genetics knowledge, and barriers/facilitators to implementation to refine the process.

NCT ID: NCT04787744 Recruiting - Prostate Cancer Clinical Trials

Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer

VA STARPORT
Start date: July 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.

NCT ID: NCT04777071 Recruiting - Clinical trials for Prostate Adenocarcinoma

An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer

Start date: May 17, 2021
Phase: Phase 2
Study type: Interventional

This trial studies how well 68Ga-PSMA-11 PET scan works in imaging patients with prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET may find and diagnose prostate cancer and improve monitoring of treatment response.