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Prostate Cancer clinical trials

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NCT ID: NCT04163068 Completed - Prostate Cancer Clinical Trials

The Improving Cancer Aftercare Study.

ICAS
Start date: January 8, 2020
Phase:
Study type: Observational

This is a qualitative interview study that aims to understand treatment burden in individuals who have experienced prostate or colorectal cancer treatment within the past five years. We intend to use patient and caregiver experiences to co-design interventions to optimise cancer aftercare. Treatment burden is the workload of healthcare for patients and the consequences of this workload on patient function. Treatment burden has been associated with negative outcomes in stroke, heart failure, diabetes, and renal failure. Cancer is increasingly becoming a chronic condition, and involves a variety of self-management tasks for patients and their caregivers. In this study investigators will investigate treatment burden in people after prostate and colorectal cancer. Investigators will seek to understand patient and caregiver perceptions about cancer aftercare, and ways that services could be redesigned and improved to reduce treatment burden, and improve patient outcomes. We will undertake a qualitative interview study, recruiting patients from general practices and oncology outpatient clinics who have completed potentially curative treatment for prostate or colorectal cancer, or who are on active surveillance or hormonal therapies for localised or locally advanced prostate cancer. We will purposively sample, to ensure that participants with comorbidities, those from lower socioeconomic groups, and rural dwellers are adequately represented. We will conduct interviews according to a schedule, informed by conceptual models of burden of treatment, Schwarzer's Health Action Process Approach, and Normalisation Process Theory. Interviews will be filmed and/or audio-recorded and transcribed. Framework and thematic analysis will be used to analyse and synthesise the data. Participants will be given the chance to comment on outputs and findings (triangulation). Investigators plan to use the results of this study, and excerpts from video interviews during co-design events, and to create new interventions to optimise aftercare for patients with prostate and colorectal cancer.

NCT ID: NCT04159090 Active, not recruiting - Prostate Cancer Clinical Trials

Head- to Head Comparison of [68Ga]Ga-PSMA-11 With [18F]PSMA-1007 PET/CT in Staging Prostate Cancer Using Histopathology and Immunohistochemical Analysis as Reference-Standard

Start date: January 15, 2018
Phase: N/A
Study type: Interventional

PSMA (Prostate Specific Membrane Antigen) is overexpressed in prostate cancer cells. The 68Ga-PSMA PET / CT test, using small molecules that bind to the PSMA protein and undergo intercellularization, is a test that has been shown to be more sensitive and specific than other conventional and molecular imaging modalities (CT, MRI, bone mapping, Disease in prostate cancer patients and its consequences often change therapeutic decisions in patients. In light of this, the examination of the health basket of the State of Israel was introduced to the staging of patients at moderate or high risk, as well as to the extent of the disease in patients with biochemical failure. However, testing with 68Ga-PSMA has several limitations, resulting from the use of 68 Ga, which can be overcome by switching to fluorine-18 (18F) -based materials: A. The generation capacity of the generator is low and therefore limits the number of tests that can be performed at a given time. In contrast, 18F is produced in cyclotron. B. 68 Ga has a short half-life of 68 minutes, which is a logical consequence of its availability to remote medical centers from the place of production, the time of the test and the patient's comfort, and the possibility of subsequent mappings. The half-life of 18F is 110 minutes. third. 18F has less energy than 68Ga (0.65 MEV vs. 1.9) and, as a result, a better maximum resolution that would potentially enable the demonstration of smaller lymph nodes involved in the disease. Among the fluorine-18 (18F) materials selected for clinical application is 18F-PSMA-1007, both because the uptake is higher in the tumor than in the background, and because its removal is mainly the pathobiliary and only a small fraction of the material is released in the urine. This is another advantage of 18F-PSMA-1007 over 68Ga-PSMA, potentially enabling a better demonstration of disease sites in the pelvis, without significant absorption of the bladder material. To date, accumulated promising experience, in Germany, in imaging with 18F-PSMA-1007. In one published case, 17 degenerative disease sites were detected in one patient with biochemical failure 9 years after undergoing radical prostatectomy, which was not demonstrated by other imaging modalities, including CT, MRI and bone mapping

NCT ID: NCT04159051 Recruiting - Prostate Cancer Clinical Trials

Charité HT-Prostate

Start date: October 2016
Phase: N/A
Study type: Interventional

The combination of regional hyperthermia and salvage radiotherapy is being tested in patients with biochemically recurrent prostate cancer after radical prostatectomy.

NCT ID: NCT04158817 Completed - Prostate Cancer Clinical Trials

68Ga-THP-PSMA PET/CT in Prostate Cancer: Clinical Stage and Restage

Start date: November 1, 2019
Phase: Early Phase 1
Study type: Interventional

To evaluate the dosimetry, safety and the detection rate of 68Ga-THP-PSMA PET/CT for identifying the site of prostate cancer metastasis and relapse. It is also to evaluate the association of clinical/pathologic features and 68Ga-THP-PSMA PET/CT detection rate and compare 68Ga-THP-PSMA PET/CT with other imaging procedure.

NCT ID: NCT04158414 Not yet recruiting - Prostate Cancer Clinical Trials

Applying PET/MR in Oncology - a Prospective Project

Start date: November 28, 2019
Phase: N/A
Study type: Interventional

Cancer is a global health issue. According to the World Health Organization, Cancer is the second leading cause of death globally, and is responsible for an estimated 9.6 million deaths in 2018. In Israel, more than 30,000 new cases of cancer were diagnosed, and more than 11,000 deaths were cancer-related during 2016. Imaging plays a pivotal role in cancer management, and multiple techniques are used in all phases of cancer management. The overall morphological, structural, metabolic and functional information obtained in imaging is used for improved individualized therapy planning. Different imaging modalities are available during different time points in the natural history of different malignancies: Early detection of cancer through screening based on imaging is probably a major contributor to a reduction in mortality for certain cancers . Once a diagnosis is made, determining the clinical stage of cancer, meaning the extent of the disease before any treatment is given, is a critical element in determining appropriate treatment based on the experience and outcomes of groups of previous patients with similar stage . Precise clinical staging of cancer is crucial. Not only that this clear non-ambiguous description is a key factor that defines prognosis, it is also a chief component of inclusion, exclusion, and stratification criteria for clinical trials. Several cancer staging systems are used worldwide. The most clinically useful staging system is the tumor, node, and metastasis (TNM) staging system developed by the American Joint Committee on Cancer (AJCC) in collaboration with the Union for International Cancer Control (UICC). The AJCC TNM system classifies cancers by the size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M). There is a TNM staging algorithm for cancers of virtually every anatomic site and histology, with the primary exception of pediatric cancers. The clinical TNM (cTNM) classification should be used to determine correctly the clinical stage of cancer and to help guide primary therapy planning.

NCT ID: NCT04154280 Not yet recruiting - Prostate Cancer Clinical Trials

Combination of 68Ga-PSMA PET Data With Magnetic Resonance Spectroscopy Data (MRS) for Evaluating Prostate Cancer

Start date: April 10, 2020
Phase: N/A
Study type: Interventional

Prostate cancer is the second most common cancer among man and the fourth most occurring over all . Characterization and management of the diagnosed prostate cancer is a challenging task due to its clinically and morphologically diversity. Clinically, this cancer range from indolent growing slowly malignancy, which does not threatened the patient life, to aggressive tumor that metastasize rapidly with very bad prognosis. Therapy of prostate cancer ranges from a "watch and wait" approach to hormone deprivation therapy to aggressive surgical, radiation, and cryosurgical therapies depending on the cancer characteristics. Prostate cancer is diagnosed using digital rectal examination, serum prostate-specific antigen (PSA) testing and transrectal ultrasonography (US)-guided biopsies . Imaging technologies have been adapted as a non-invasive method to obtain a comprehensive assessment of the disease. MRI is widely used and more specifically multiparameter MRI (mMRI) for detection, staging and tumor localization. mMRI uses multiphase modes including diffusion-weighted and dynamic contrast-enhanced imaging in addition to T2-weighted imaging to identify and classify cancer type . Magnetic Resonance Spectroscopy (MRS) is MRI technique that allow detection of tissue metabolic composition which is occasionally used to characterize prostate cancer, however is not used as a standard procedure. By suppression of water and fat signal, MRS sequence can detect relationship between lower concentration prostatic metabolites such as citrate, choline, creatine, and polyamines in the cell cytosol and in the extra cellular ducts. Other imaging modalities used to characterize prostate cancer include ultrasound (US), computerized tomography (CT), functional imaging like bone scanning (BS) and hybrid imaging like choline based positron emission tomography and CT (PET/CT). However all of these modalities show disappointing sensitivity .

NCT ID: NCT04147806 Active, not recruiting - Prostate Cancer Clinical Trials

A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer

PROSINT
Start date: August 1, 2016
Phase: Phase 2
Study type: Interventional

The present study evaluates clinical outcomes and treatment-related toxicity following definitive ultra-high dose external beam radiotherapy delivered with two different regimens in patients with intermediate-risk adenocarcinoma of the prostate. Modern computer-driven technology enables the implementation of ultra-high hypofractionated Image-Guided Radiotherapy (IGRT) safely. Prostate cancer patients classified according to the current National Comprehensive Cancer Network (NCCN) guidelines as intermediate risk (biopsy Gleason score of 7 and/or Prostate Specific Antigen (PSA) level >10 and ≤20 ng/mL and/or Stage T1, T2a, T2b or T2c) are eligible for this study. Patients will undergo IGRT with volumetric intensity-modulated arc radiotherapy (VMAT) with state-of-the-art treatment-planning and quality assurance procedures. Emphasis is placed on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility. A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility, while a urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking. Previously untreated patients with intermediate-risk prostate cancer will be prospectively randomized to receive either 45 Gy in five fractions of 9 Gy each vs. 24 Gy in a single-dose. Patients will be followed at one month post-treatment and every 3 months for up to 12 months (+/- 4 weeks) and every 6 months thereafter. Acute and chronic toxicity evaluations will focus on urinary, rectal and sexual functions and will be assessed through validated questionnaires. Serum PSA values will be regularly acquired during follow-up. A multiparametric MRI will be performed at baseline, 6, 12 and 24 months following intervention. Additionally, a post-treatment diffusion-weighted MRI (DW-MRI) will be performed within 15 minutes of the first treatment, to measure early physiologic changes, such as perfusion and ischemia, that may correlate with clinically relevant end-points. Post-treatment prostate needle biopsies will be obtained at 24 months to evaluate pathologic response to therapy. The study will be continuously monitored for a minimum of 5 years. In the event unexpected severe (grade ≥3) toxicities are observed in any one of the treatment arms, the study will be terminated according to the stopping rule >3/first 15 patients.

NCT ID: NCT04146077 Recruiting - Prostate Cancer Clinical Trials

Active Surveillance for Low Risk Prostate Cancer

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

An active surveillance protocol for patients diagnosed low-risk prostate cancer will be held. We plan to use PSA (prostate-specific antigen) testing, DRE (digital rectal examination), TRUS (transrectal ultrasound), MRI (magnetic resonance imaging) and follow-up biopsies to monitor patients and detect cancer progression in time.

NCT ID: NCT04144127 Completed - Prostate Cancer Clinical Trials

Soccer Intervention in Prostate Cancer Survivors

Start date: October 25, 2019
Phase: N/A
Study type: Interventional

This study seeks to directly test the implementation feasibility of a soccer-based and lifestyle education intervention to determine the effects on bone health, body composition, mental health, functional and cardiometabolic status among prostate cancer survivors.

NCT ID: NCT04138914 Active, not recruiting - Prostate Cancer Clinical Trials

Phase II Trial of Focal Cryotherapy for Prostate Cancer

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

The current standard of care treatment for prostate cancer confined to the prostate is surgical removal or irradiation of the entire prostate gland. This is effective at curing cancer but result in damage to critical adjacent structures such as the urinary sphincter muscle and erectile nerves resulting in impaired urinary continence and erectile dysfunction. The concept of focal therapy is to treat just the dangerous focus of cancer in the prostate while monitoring the rest of the gland, thus avoiding impairment of urinary continence and erectile function. We aim to evaluate the degree of preservation of continence and erectile function and early oncological outcomes in patients undergoing focal therapy of the prostate using cold energy or cryo- ablation. In this study, we seek to evaluate patient reported outcomes in urinary, sexual, bowel and general health areas at fixed time points after focal cryo-ablation in selected patients with low-volume, localized cancer. The primary goal of this study is to demonstrate whether there is a deterioration of scores in these health areas over 1 year of follow-up. The secondary goal is to measure cancer control at 1 year re-biopsy. Further goals include longer follow-up to monitor cancer progression rates and impact on patient survival.