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Prostatic Neoplasms clinical trials

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NCT ID: NCT06242119 Recruiting - Prostate Cancer Clinical Trials

Clinical Application of the J-PET Scanner Prototype

JPET2Clinic
Start date: March 7, 2024
Phase:
Study type: Observational

Positron emission tomography (PET), an advanced diagnostic imaging technique, exploits the annihilation of positrons (e+) to delineate pathological alterations within diseased tissues. Integral to PET scanners are detector systems that transform gamma photons into fluorescent photons, thereby gleaning insights into the energy, time, and spatial distribution of gamma photons emanating from positron-emitting radiopharmaceuticals. Conventional PET scanners, bear a significant financial burden primarily due to their reliance on LSO (lutetium oxyorthosilicate) or LYSO (lutetium yttrium oxyorthosilicate) scintillation crystals. The exorbitant cost and limited availability of these crystal scintillators impede the widespread adoption of PET scanners. In a departure from conventional PET technology, the prototype J-PET scanner employed in this trial employs plastic scintillators, characterized by unique physical properties. This prototype is further equipped with bespoke software enabling three-photon imaging based on the annihilation of ortho-positronium (o-Ps) generated within diseased tissue. This study delves into the clinical applicability of PET scanners employing plastic scintillators, particularly investigating the feasibility of PET imaging using plastic scintillators where gamma quanta interact by mechanisms other than the photoelectric effect. Furthermore, this study endeavors to contemporaneously acquire and analyze data related to the lifetime of ortho-positronium (o-P) atoms emanating from routine radiopharmaceuticals. Additionally, it seeks to validate the utilization of a novel diagnostic indicator, termed the "positron biomarker," through a prospective study, comparing its efficacy to conventional diagnostic PET scanning methodologies.

NCT ID: NCT06241846 Recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)

A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC

Start date: February 22, 2024
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label, Phase 2 study. The study will enroll subjects with metastatic castration-resistant prostate cancer (mCRPC) previously treated with at least 1 prior line of novel hormone therapy (NHT). NHT includes abiraterone, enzalutamide, apalutamide, darotamide, or rezvilutamide. Subjects must have received no more than 2 prior lines of taxane-containing regimen. This study consists of two parts. Part 1 will preliminarily assess the efficacy and tolerability of YL201 at 2.0, 2.4, or 2.8 mg/kg with approximately 40 subjects. Part 2 will further assess the efficacy and safety of YL201 at the recommended expansion dose (RED) obtained from Part 1 with up to 60 subjects. YL201 will be administered intravenously (IV) on Day 1 of each 3-week cycle until criteria of treatment discontinuation are met. Subjects will undergo regular testing for signs of disease progression (PD) using computed tomography (CT) scan, magnetic resonance imaging (MRI), bone scan, and prostate-specific antigen (PSA) blood test. Routine examinations and blood tests will be performed and evaluated by the study physician.

NCT ID: NCT06238713 Recruiting - Clinical trials for Prostate Adenocarcinoma

Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)

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

This study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics.

NCT ID: NCT06238596 Recruiting - Rehabilitation Clinical Trials

Rehabilitation Intervention to Prevent Adverse Events Related to Androgen-deprivation Therapy (ADT) in Patients With Metastatic Prostate Cancer (PCa): a Single Arm Feasibility Study (ReCaP Study)

ReCaP
Start date: September 6, 2023
Phase: N/A
Study type: Interventional

This is a drug-free, single arm, single center, superiority, interventional study aimed at treatment feasibility. The main aim of the current study is to assess feasibility of a tailored exercise program as measured by adherence to exercise program in metastatic PCa patients undergoing ADT. Secondary aims are: to deepen the knowledge on other feasibility aspects (recruitment/retention), to monitor safety, to assess the effects in reducing the AEs of ADT (on loss of strength, loss of physical performance and fatigue, number of accidental falls and fractures), to monitor pain and the change in physical activity habits. The rehabilitation intervention will be led by a Physiotherapist and will include: a 12 weeks standardized multicomponent exercise (aerobic, resistance, balance and flexibility, and impact exercise if indicated), supervised by the physiotherapist, on an outpatient basis or in telerehabilitation. This program will be adapted to single patient needs. Every exercise session will last almost 60 minutes and patients will be supervised twice a week. One more exercise session per week will be self-managed by patients. At baseline a physiatrist will visit patients with bone metastasis and collect data on sites of bone metastasis, associated level of pain, and risk of pathological fractures. For all participants, the physiotherapist will assess muscle strength (Hand Grip Strength-HGS), physical performance (Short Physical Performance Battery-SPPB), level of fatigue (FACIT-F), and data collection on physical activity habits (International Physical Activity Questionnaire-IPAQ). The enrollment will be closed after 1 year from the activation of the study or when the target of patients will be reached, whichever occurs firstly. For each patient, data will be collected for 12 months. The duration of the study is expected to be around 2 years. Follow-ups are scheduled at 12 weeks, 24 weeks and 12 months.

NCT ID: NCT06237179 Recruiting - Prostate Cancer Clinical Trials

Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

EXTRA-PC
Start date: February 21, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak & 6-minute walk distance [6MWD]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.

NCT ID: NCT06237114 Recruiting - Prostate Cancer Clinical Trials

Novel Robotic Prostatectomy Technique for Early Urinary Continence

TRS-RALP
Start date: March 8, 2024
Phase:
Study type: Observational

The goal of this a single arm prospective study is to evaluating the 3-month return of urinary continence outcomes of patients undergoing the transvesical retzius sparing robotic radical prostatectomy (TRS-RALP) for standard of care surgical prostate removal for treatment of prostate cancer. The main question it aims: To have patients respond to questionnaires to collect exploratory data on patient's quality of life (QoL; EuroQol-5 Dimension 5-Level [EQ-5D-5L] and prostate cancer related urinary, bowel, and sexual function questionnaires (Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP), at their standard of care perioperative visits at baseline and at 4 weeks, 3- and 6-months post operatively.

NCT ID: NCT06236789 Recruiting - Prostatic Neoplasm Clinical Trials

Observation Study to Evaluate the Efficacy and Safety of Ifosfamide/Mesna in Patients With Metastatic Castration-resistant Prostate Cancer

Start date: November 2016
Phase:
Study type: Observational

Prostate cancer is the 2nd most common cancer in men worldwide. Based on the results of several recent clinical trials, systemic treatments including hormone inhibitors, docetaxel, cabazitaxel, and PARP inhibitors are being used as standard treatment for patients with metastatic castration-resistant prostate cancer. However, there is insufficient research on salvage therapy for patients with metastatic castration-resistant prostate cancer who have failed standard treatment. In this study, the investigators will evaluate the effectiveness and safety of ifosfamide in castration-resistant prostate cancer by analyzing the treatment outcomes of patients who received ifosfamide/mesna treatment as salvage therapy.

NCT ID: NCT06235697 Recruiting - Prostate Cancer Clinical Trials

Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment

ASCENDE-SBRT
Start date: April 25, 2024
Phase: Phase 3
Study type: Interventional

This study is being done to answer the following question: Is the strategy to give higher doses of radiotherapy treatment over a shorter period of time using special equipment and fewer treatments (also known as Stereotactic Body Radiation Therapy or SBRT) as effective as usual external radiation therapy given with a brachytherapy boost (which involves radiation sources inserted directly into the prostate)?

NCT ID: NCT06235151 Recruiting - Prostate Cancer Clinical Trials

Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer

Solar-Stage
Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.

NCT ID: NCT06235099 Recruiting - Prostate Cancer Clinical Trials

Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

Solar-Recur
Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with recurrent prostate cancer after radical prostatectomy or radiation therapy.