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Prostate Cancer Metastatic clinical trials

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NCT ID: NCT05553639 Recruiting - Clinical trials for Prostate Cancer Metastatic

HB-302/HB-301 Therapy in Participants With Metastatic Castration-Resistant Prostate Cancer

Start date: May 23, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a first-in-human Phase 1/2, multinational, multicenter, open-label study of HB-302/HB-301 alternating 2-vector therapy in participants with metastatic castration-resistant prostate cancer (mCRPC) comprising 2 phases: a Phase 1 Dose Escalation and recommended Phase 2 dose (RP2D) Confirmation, and a Phase 2 Dose Expansion.

NCT ID: NCT05457699 Recruiting - Clinical trials for Prostate Cancer Metastatic

Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)

ANCHORProstate
Start date: December 30, 2022
Phase: Phase 2
Study type: Interventional

A phase IIR cmRCT trial companion to PERa registry, investigating the merit of SABR consolidation in men with metastatic prostate cancer. 80 patients will be randomly selected to be offered experimental SABR based on PSMA-PET detected disease after maximal systemic response. The primary endpoint is the rate of FFS at 1 year. Patients will be stratified according to hormone sensitive vs resistant disease prior to randomisation.

NCT ID: NCT05384002 Recruiting - Prostate Cancer Clinical Trials

An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum

Start date: February 24, 2021
Phase:
Study type: Observational [Patient Registry]

In Europe, prostate cancer (PCa) is the second most frequent type of cancer in men and the third most lethal. Current clinical practices, often leading to overdiagnosis and overtreatment of indolent tumors, suffer from lack of precision calling for advanced AI models to go beyond SoA by deciphering non-intuitive, high-level medical image patterns and increase performance in discriminating indolent from aggressive disease, early predicting recurrence and detecting metastases or predicting effectiveness of therapies. To date efforts are fragmented, based on single-institution, size-limited and vendorspecific datasets while available PCa public datasets (e.g. US TCIA) are only few hundred cases making model generalizability impossible. The ProCAncer-I project brings together 20 partners, including PCa centers of reference, world leaders in AI and innovative SMEs, with recognized expertise in their respective domains, with the objective to design, develop and sustain a cloud based, secure European Image Infrastructure with tools and services for data handling. The platform hosts the largest collection of PCa multi-parametric (mp)MRI, anonymized image data worldwide (>17,000 cases), based on data donorship, in line with EU legislation (GDPR). Robust AI models are developed, based on novel ensemble learning methodologies, leading to vendor-specific and -neutral AI models for addressing 8 PCa clinical scenarios. To accelerate clinical translation of PCa AI models, we focus on improving the trust of the solutions with respect to fairness, safety, explainability and reproducibility. Metrics to monitor model performance and a causal explainability functionality are developed to further increase clinical trust and inform on possible failures and errors. A roadmap for AI models certification is defined, interacting with regulatory authorities, thus contributing to a European regulatory roadmap for validating the effectiveness of AI-based models for clinical decision making.

NCT ID: NCT05352178 Recruiting - Prostate Cancer Clinical Trials

Metastasis-directed Therapy for Oligorecurrent Prostate Cancer

SPARKLE
Start date: April 20, 2022
Phase: Phase 3
Study type: Interventional

The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed therapy (MDT) significantly prolongs poly-metastatic free survival (PMFS) and/or metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.

NCT ID: NCT05327465 Recruiting - Prostate Cancer Clinical Trials

Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy

Start date: August 11, 2022
Phase: N/A
Study type: Interventional

The purpose of this research is to determine whether a 16-week culturally tailored, technology-based, aerobic and resistance exercise intervention improves cardiovascular risk factors in Black men diagnosed with prostate cancer and are undergoing androgen deprivation therapy (ADT), and whether it will also improve physical fitness and function, body composition, and outcomes such as quality of life, cancer symptoms, and self-esteem. Participants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.

NCT ID: NCT05283330 Recruiting - Breast Cancer Clinical Trials

Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

Start date: December 22, 2022
Phase: Phase 1
Study type: Interventional

A Phase 1 SAD/MAD dose escalation and expansion study to determine the safety and effectiveness of ²¹²Pb-DOTAM-GRPR1 in subjects with various GRPR-expressing Tumors

NCT ID: NCT05242744 Recruiting - Clinical trials for Prostate Cancer Metastatic

FTT PET/CT in Metastatic Prostate Cancer

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

Up to 30 men with metastatic prostate cancer will undergo up to 2 FTT PET/CT scans to look at PARP activity in sites of known cancer. Subjects will undergo a baseline scan prior to starting new therapy and a second, optional, post-therapy scan 1-21 days after the start of treatment. Tissue from a clinical or research biopsy will be compared to imaging measures, if available.

NCT ID: NCT05078151 Recruiting - Clinical trials for Prostate Cancer Metastatic

Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (MRI) as a Response Biomarker for Metastatic Prostate Cancer

iPROMET
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The skeleton is the most frequent organ of distal metastases in prostate cancer, often representing the only site of metastatic disease. Still, assessment of response and progression to therapies in bone metastases remains a major unmet need, to aid treatment switch decisions, detecting primary/secondary resistance and to optimize drug development. The currently used standard imaging techniques, computed tomography (CT) and bone scintigraphy (BS), do not depict the true extent of bone metastases and are suboptimal in capturing biological changes occurring in response to treatment. This results in treatment switch decisions too often being based on PSA changes, which is neither a surrogate of survival, nor an optimal response biomarker.Diffusion-weighted imaging (DWI) is a functional magnetic resonance imaging (MRI) technique that studies the movement of water molecules within a tissue and provides valuable information about the tissue microstructure and cellularity. Whole body MRI with DWI is highly accurate for bone metastases detection, outperforming the standard CT and BS and other imaging techniques when assessing bone metastases. The investigators hypothesise that DWI changes are a response biomarker in bone metastases from metastatic castration resistant prostate cancer (mCRPC); these DWI changes can be detected as early as after 4 weeks of systemic treatment.

NCT ID: NCT05067140 Recruiting - Clinical trials for Prostate Cancer Metastatic

A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer

Start date: September 2, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase 1/2 study to evaluate the safety and efficacy of ARV-766 given by mouth alone or in combination with abiraterone in men with metastatic prostate cancer.

NCT ID: NCT05000827 Recruiting - Prostate Cancer Clinical Trials

Dutch National Randomized Study: PSMA-PET/CT as a Triage Tool for Pelvic Lymph Node Dissection in Prostatectomy Patients

PSMA-SELECT
Start date: July 28, 2021
Phase: N/A
Study type: Interventional

To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET/CT) as a selection tool for performing extended lymph node dissection (ePLND) for prostate cancer (PCa) in the primary staging setting results in fewer ePLND procedures and therefore lower overall healthcare costs, lower patient burden in terms of intervention-related complications and morbidity, with comparable disease prognosis, compared to the current European Guideline-recommended standard practice which includes performing ePLND in PCa patients who are candidates for active treatment with a nomogram-calculated lymph node involvement (LNI) risk >5%.