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Prostatic Neoplasms clinical trials

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NCT ID: NCT05676203 Recruiting - Clinical trials for Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients

ARASAFE
Start date: May 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this clinical phase 3 randomized trial is to compare two different dosing schedules of Docetaxel in combination with ADT and Darolutamide in subjects with mHSPC. The main question aims to compare grade 3-5 adverse events (AEs) in patients with mHSPC treated with 6 cycles of either Docetaxel 75 mg/m2 every 3 weeks in a 3 week cycle or 6 cycles of Docetaxel 50 mg/m2 every 2 weeks in a 4 week cycle in combination with Darolutamide + ADT. The primary endpoint are Grade 3-5 AEs, followed by neutropenia grade 3/4 + grade 5 AEs to be analysed 28 weeks after last patient first Docetaxel dose (LPFD).

NCT ID: NCT05672485 Recruiting - Prostate Cancer Clinical Trials

99mTc-P137 SPECT/CT in Prostate Cancer

Start date: January 5, 2023
Phase: N/A
Study type: Interventional

Purpose: This study will take prostate specific membrane antigen (PSMA) as the targeting of radionuclide labeled molecular probe to explore the diagnostic efficacy of 99mTc-P137 radioactive probe in prostate cancer. Combining with SPECT/CT to optimize the imaging, image analysis and clinical diagnosis process of 99mTc-P137 probe, the aim of the study is to provide new methods and new means for the early detection, early diagnosis, accurate tumor staging, treatment decision and prognosis judgment of malignant tumor, and will provide scientific and clinical basis for the precise diagnosis and treatment of prostate cancer. Research objectives: To investigate the clinical translational application value of 99mTc-P137 molecular probe in accurate detection of prostate cancer lesions. Research design: A prospective study design will be used in this study. Patients meeting the inclusion criteria of this study will be analyzed with 99mTc-P137 SPECT/CT imaging. To evaluate the diagnostic and prognostic value of 99mTc-P137 nuclear medicine imaging in accurate detection of prostate cancer lesions, clinical surgical specimens and pathological diagnosis will be used as the gold standard. Study the population Indications: For patients with suspected prostate cancer who plan to undergo surgical resection or puncture biopsy after various examinations, the final pathological results can be obtained.

NCT ID: NCT05669443 Recruiting - Prostate Cancer Clinical Trials

Effect of Optimized PEEP on Mechanical Ventilation During Robot Assisted Laparoscopic Prostatectomy

Start date: April 3, 2023
Phase: N/A
Study type: Interventional

Steep trendelenburg posture or pneumoperitoneum for surgery causes ventilation problems during surgery, so finding a way to overcome is a challenging task for anesthesiologists. In this study, for patients undergoing robot assisted laparoscopic prostatectomy under general anesthesia, anesthesia is going to perform by applying conventional positive end-expiratory pressure (PEEP 5cmH2O) or individually determined positive end-expiratory pressure values for each patient using electrical impedance tomography. We plan to compare intraoperative ventilation through arterial blood gas analysis to find out the way to improve intraoperative ventilation.

NCT ID: NCT05668351 Recruiting - Prostate Cancer Clinical Trials

Stereotactic Ablative Radiation Therapy for Prostate Cancer

SUPR-SABR
Start date: May 12, 2023
Phase: N/A
Study type: Interventional

This single arm trial will investigate a novel way to plan and deliver SABR for prostate cancer. Prostate-directed SABR will be high-dose SABR (40 Gy in 5 fractions) with central sparing of the urethra and peripheral sparing of the rectum and pudendal arteries (SUPR-SABR). This study tests the hypothesis that genitourinary (GU) and gastrointestinal (GI) toxicity rates following SUPR-SABR are comparable to (or possibly lower than) historical GU and GI toxicity rates following standard SABR (stSABR) with 36.25 Gy in the treatment of low- and intermediate-risk prostate cancer.

NCT ID: NCT05667636 Recruiting - Prostatic Neoplasm Clinical Trials

Early Salvage Stereotactic Radiotherapy for Biochemical Failure After RP

esSBRT
Start date: September 27, 2022
Phase: Phase 2
Study type: Interventional

After radical prostatectomy, 30-60% of patients will develop recurrent disease. Salvage radiotherapy, usually at 2 Gy per fraction, is the main treatment option for these patients. The aim of the present study is to determine the 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after radical prostatectomy.

NCT ID: NCT05656794 Recruiting - Prostate Metastases Clinical Trials

Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer

CONSORT-PC
Start date: July 31, 2023
Phase: Phase 2
Study type: Interventional

This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.

NCT ID: NCT05656573 Recruiting - Prostate Cancer Clinical Trials

CART-PSMA Cells for Advanced Prostate Cancer

Start date: March 1, 2023
Phase: Phase 1
Study type: Interventional

This is a single center, open-label phase 1 study to assess the safety and feasibility of PSMA-specific CAR modified autologous T cells (CART-PSMA cells) in patients with advanced prostate cancer.

NCT ID: NCT05655715 Recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer

Checkpoint Inhibitors and SBRT for mCRPC

CheckPRO
Start date: November 25, 2019
Phase: Phase 2
Study type: Interventional

The goal of this investigator-initiated, single-center, and randomized phase II trial is to investigate the potential synergistic effect of combining stereotactic body radiotherapy of a single soft tissue- or bone metastasis with ipilimumab and nivolumab in patients with mCRPC and perform translational analyses on tissue and blood, searching for predictive biomarkers of efficacy and toxicity. Participants will be randomized to receive ipilimumab and nivolumab with or without stereotactic body radiotherapy (SBRT).

NCT ID: NCT05653063 Recruiting - Cancer of Prostate Clinical Trials

ARCHERY - Artificial Intelligence Based Radiotherapy Treatment Planning for Cervical, Head and Neck and Prostate Cancer

Start date: December 7, 2023
Phase:
Study type: Observational

The aim of this study is to look at whether an Artificial Intelligence (AI) based computer program can automate two components of the radiotherapy treatment pathway to a sufficient quality standard to enable its routine clinical use. The two components include the delineation (outlining) of anatomical areas that are at risk of tumour spread and at risk of radiation damage, and the definition of the position, size and shape of the radiation beams. The AI-based computer programs have been developed to perform tasks that would normally require direct human involvement by oncologists and medical physicists. Proposed advantages include improved treatment accuracy, as well as a reduction in the time (from weeks to minutes) and human resources needed to deliver radiotherapy, which this study will test.

NCT ID: NCT05652686 Recruiting - Clinical trials for Small Cell Lung Cancer (SCLC)

A Study of PT217 in Patients With Neuroendocrine Carcinomas Expressing DLL3 (the SKYBRIDGE Study)

Start date: September 5, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

PT217 is a bispecific antibody (bsAb) against human DLL3 (huDLL3) and human CD47 (huCD47). This is a first-in-human, Phase 1/2, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT217 in subjects with neuroendocrine carcinomas. Patients with the following tumor types will be eligible for screening: small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), and extrapulmonary neuroendocrine carcinoma (EP-NEC), including but not limited to neuroendocrine prostate cancer (NEPC) and gastroentero-pancreatic neuroendocrine carcinoma (GEP-NEC). Patients must have progressed after standard therapy (platinum-based chemotherapy) or standard therapy has proven to be ineffective, intolerable or is considered inappropriate.