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Prostate Cancer clinical trials

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NCT ID: NCT06284304 Recruiting - Prostate Cancer Clinical Trials

A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL

DESTINATION
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Trial design: A single centre phase II non-randomised study Trial population: Men with intermediate risk localised prostate cancer Recruitment target: 20 patients in total Trial objectives: - Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects - Secondary - To assess levels of acute GU and GI toxicity (CTCAE) - To assess levels of late GU and GI toxicity (CTCAE) - To assess late sexual quality of life (expanded EPIC, IIEF-5) - To assess biochemical relapse-free survival at 2 years Trial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.

NCT ID: NCT06282588 Recruiting - Prostate Cancer Clinical Trials

Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers

THUNDER
Start date: December 13, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. Novel radiotracers and a genomic classifier (Decipher) will be used to guide treatment decisions, instead of standard imaging which is limited by lower sensitivity and specificity. The hypothesis for the study is that treatment intensification based on a positive PSMA PET/ CT scan or Decipher high score (> 0.6) improves time to new metastases detected on PSMA PET/ CT in high-risk PCa. In patients who are PSMA PET/ CT negative with a low/ intermediate Decipher score (≤ 0.6), it is hypothesized that treatment de-intensification will improve patient quality of life while maintaining a good oncological outcome. The study will be conducted at multiple centers across Europe. Participation in the study will comprise a screening period, where the screening assessments must be completed before subjects are enrolled and randomized (only for Phase 3 subjects). Eligible, consenting subjects will then undergo treatment according to their assigned study phase and treatment group, to occur over up to 96 weeks (24 months) with a post-treatment follow-up period to monitor safety and efficacy. The study will be closed when 96 events have been registered for the primary endpoint, which is expected to be at 7-8 years from the time of randomization of the first subject.

NCT ID: NCT06281769 Not yet recruiting - Prostate Cancer Clinical Trials

Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision

Start date: February 26, 2024
Phase: N/A
Study type: Interventional

The primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI (MRI pathway).

NCT ID: NCT06280781 Not yet recruiting - Prostate Cancer Clinical Trials

Imperial Prostate 9 - ATLAS (Approaches To Long-Term Active Surveillance)

IP9-ATLAS
Start date: July 2024
Phase: N/A
Study type: Interventional

The goal of this intervention study is for patients on active surveillance for prostate cancer, to demonstrate that use of regular MRI scans is better able to detect cancer progression over 5 years compared to the current NICE defined strategy. Research Question P - In patients who are on active surveillance for low to medium risk prostate cancer, I - is the use of regular MRI scans C - compared to current NICE defined standard of care, O - better at detecting cancer progression with less cost to the NHS (fewer PSA tests, biopsies and clinic visits)? Patients will be allocated in a 1.1 ratio to either MRI scans or the current NICE defined standard. Randomisation will be blocked (random block size) and stratified by MRI visibility of lesions (3 categories [ no visible lesion, diffuse changes, discrete visible lesion]), cancer Grade Group (GG1, GG2) and time since diagnosis. This study will not be blinded to patients or physicians.

NCT ID: NCT06279260 Not yet recruiting - Prostate Cancer Clinical Trials

National Robotics-Assisted Radical Prostatectomy Database

RoPCa-ND
Start date: April 2024
Phase:
Study type: Observational [Patient Registry]

Surgical notes are detailed reports written by surgeons during and after surgeries. These notes cover everything from the techniques, instruments used, any issues with the surgical procedure and post-surgical care for the patient. This information is a treasure trove for researchers because they can study it to understand how surgeries go, what works best, and how certain treatments affect patients. By looking closely at these notes, researchers can find patterns and trends, helping them in understanding what makes surgeries successful and identify the best ways to perform them. This information is crucial for creating guidelines based on solid evidence. Also, these surgical notes are a goldmine for looking back at past surgeries to see how they have affected patients in the long run. The real power for research comes when we combine these surgical notes within the Electronic Medical Records (EMR) and research databases. This makes it easy to collect information systematically, making it simpler for researchers to study a large number of cases. Unfortunately, not many people have paid attention to this idea for a long time, leading to big gaps in the data collection. To address this issue, we aim to create a database that collects information from surgical notes effortlessly. This includes details about how surgeons are trained and how they progress. It's important to make sure that doctors work aligns with research - which is the best way to address data collection issues. This data can also help record different technical aspects of surgery and different surgeons' learning curve, making it easier to compare and improve training. Thus, we aim to standardise notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy.

NCT ID: NCT06274892 Not yet recruiting - Breast Cancer Clinical Trials

Remote Monitoring of Patient Reported Outcomes to Improve the Efficacy of the Acute Phase Radiotherapy Review Process

PROMOTE
Start date: February 28, 2024
Phase: N/A
Study type: Interventional

Radiation therapy (RT) is a key component in the treatment of breast and prostate cancer. However, patients may experience significant side effects. Patients can accurately self-report side effects from RT and these patient-reported outcomes (PROs) can direct communication between patient and healthcare provider (HCP), and facilitate joint decision making. Patients state that using mobile phone applications (apps) to collect PROs (mPROs) is easily incorporated into their daily routines, allowing them to engage at a time and pace that suits them. When mPRO collection is combined with remote symptom monitoring by HCPs, these systems result in improvements in symptom control and quality of life. Currently, patients receiving RT are seen by a Radiation Oncologist once per week during RT and once every few months after RT has finished. Recent evaluations indicate that patients and physicians consider the number of visits to be too frequent during RT, and too infrequent immediately after RT. This research will use weekly mPROs (remotely monitored by RT HCP) to determine if a patient needs (or wants) to be seen by a RT HCP during and/or immediately after RT. Using mPROs to optimize RT patient assessment processes will ensure patients are seen if and when required. For a patient, this could result in reduced time and costs at the hospital. For the physician, resources could be re-allocated to improve access to RT services. Using mPROs after RT has the potential for earlier treatment of side effects, which has been linked to improved survival and quality of life.

NCT ID: NCT06274684 Not yet recruiting - Prostate Cancer Clinical Trials

Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia.

Start date: February 19, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the impact of Virtual Reality (VR) assistance for anxiety management of patients undergoing prostate biopsies in local anaesthesia. The main question it aims to answer: - Is there a significant decrease on anxiety level thanks to VR-assistance? Participants will be equipped with VR headset providing an immersive visual experience accompanied with a hypnoses oriented audio during the entire procedure. Researchers will compare standardised anxiety scores with a control group.

NCT ID: NCT06274047 Not yet recruiting - Prostate Cancer Clinical Trials

PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.

Start date: August 31, 2024
Phase: Phase 3
Study type: Interventional

1. Personalize treatment for prostate cancer based on how aggressive the disease is and 2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy.

NCT ID: NCT06271551 Not yet recruiting - Prostate Cancer Clinical Trials

Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy

ESTRACISE
Start date: March 2024
Phase: Phase 2
Study type: Interventional

The goal of the clinical trial is to find out whether transdermal estradiol will reduce the adverse effects of androgen deprivation therapy in prostate cancer patients. The primary aim of this study is to estimate the efficacy of transdermal estradiol (E2) in reducing androgen deprivation therapy induced adverse effects on sexual function. A secondary aim of this study is to estimate the utility of E2 and the combination of E2 with supervised exercise in reducing other androgen deprivation therapy related adverse effects. Participants (n=310) will use transdermal estradiol for 12 months concomitant to androgen deprivation therapy. The use of transdermal estradiol will start at the beginning of the trial, at the same time as androgen deprivation therapy. A subgroup of participants (n=120) will also be allocated to perform six months supervised resistance training. Researchers will compare transdermal estradiol group to control group, and resistance training groups and non-training control groups.

NCT ID: NCT06270043 Recruiting - Prostate Cancer Clinical Trials

Focal Therapy for Localized Prostate Cancer

Start date: February 1, 2024
Phase:
Study type: Observational [Patient Registry]

This prospective registry and longitudinal study that is designed to carefully measure details of prostate cancer patients' outcomes with focal therapy. The goal of which is to improve patient care.