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Prostate Cancer Metastatic clinical trials

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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: NCT05627778 Recruiting - Clinical trials for Prostate Cancer Metastatic

68Ga-P15-041 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Prostate Bone Metastasis

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

Tumor bone metastasis refers to the metastasis of malignant tumors to the bone through lymph, blood or direct invasion to generate daughter tumors, which is the most common bone tumor. More than 40% of patients with malignant tumors will have bone metastasis, among which breast cancer, prostate cancer is more common, once the tumor cells occur bone metastasis, it means that the disease enters the advanced stage, posing a serious threat to the life safety of patients, therefore, early diagnosis of various primary malignant tumor bone metastases, can lay the foundation for clinical implementation of effective treatment measures. The laboratory of Hank F. Kung at the University of Pennsylvania has developed a new generation of 68Ga-labeled radiopharmaceutical P15-041 ([68Ga]Ga-HBED-CC-BP) based on existing phosphonate-targeting molecular probes (Figure 1). Data from preclinical studies indicate that P15-041 shows additional advantages in rapid and easy complex formation compared to current [68Ga]Ga-BPAMD, [68Ga]Ga-NO2AP-BP, [68Ga]Ga-DOTA- (ZOL). In vivo experiments, P15-041 showed good bone resorption and rapid renal excretion in normal mice. Haiyan Hong et al. [13] prepared multiple clinical doses of P15-041 and successfully evaluated it in patients, followed by intravenous P15-041, followed by a whole body PET/CT scan. Robert K. Doot et al. conducted dosimetric experiments on P15-041, analyzed the radioactive distribution of the drug in normal organs and the dynamic change of the dose of the drug in the body over time, and the results showed that P15-041 had high uptake in the bladder wall and bone cortex, blood and other tissues cleared quickly, and there was obvious radioactive enrichment in the myocardium in the early stage of imaging, and P15-041 had the potential to become a new generation of excellent phosphonate molecular probes.

NCT ID: NCT05570994 Recruiting - Clinical trials for Metastatic Castration-resistant Prostate Cancer

177Lu-HTK03170 in mCRPC With PSMA Positive Disease

Start date: January 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study will determine the safe initial injected activity of the radioligand therapy 177Lu-HTK03170 for the measurement of dosimetry and initiation of treatment in subjects with PSMA-positive, metastatic castrate resistant prostate cancer, (mCRPC). Subjects will receive treatment which will be escalated between cycles and personalized based on dosimetry calculations and imaging. In addition, antitumour activity will be measured by radiographic response, and further assessments of the treatment will be measured by CT imaging, ctDNA/ctRNA, PSA, PSMA PET/CT, and quality of life questionnaires. Subjects will be followed for 2 years or until they have progression and are switched to another systemic treatment.

NCT ID: NCT05567770 Withdrawn - Clinical trials for Prostate Cancer Metastatic

ACTInium-J591 Radionuclide Therapy in PSMA-Detected Metastatic HOrmone-Sensitive Recurrent Prostate CaNcer

ACTION
Start date: December 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of combining Actinium- J591 with radiation therapy or with androgen deprivation therapy.

NCT ID: NCT05563558 Recruiting - Clinical trials for Prostate Cancer Metastatic

Pembrolizumab, Carboplatin and Cabazitaxel in Aggressive Metastatic Castration Resistant Prostate Cancer (PEAPOD_FOS)

PEAPOD_FOS
Start date: May 5, 2023
Phase: Phase 2
Study type: Interventional

It is a Phase 2 clinical trial of Pembrolizumab in combination with Carboplatin and Cabazitaxel in Aggressive Variant Metastatic Castration Resistant Prostate Cancer. It is divided into two parts: an induction period of 6 cycles of 3 weeks each cycle of Pembrolizumab+Cabazitaxel+Carboplatino and a maintenance phase of 15 cycles of 6 weeks each cycle of Pembrolizumab.

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: NCT05530395 Not yet recruiting - Clinical trials for Prostate Cancer Metastatic

BAseLine TEstosterone as a Prognostic and/or Predictive bioMARKer in mHSPC

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

Despite large amounts of basic-science data supporting a role for androgens in PCa pathogenesis, there are conflicting clinical data on the role of endogenous testosterone in human de novo PCa pathogenesis. The investigators hypothesize that lower baseline serum testosterone is significantly associated with worse clinical outcomes in mHSPC patients undergoing continuous medical castration

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: NCT05361915 Suspended - Prostate Cancer Clinical Trials

Study to Assess Abivertinib in Combination With Abiraterone in Metastatic Castration Resistant Prostate Cancer

Start date: September 2025
Phase: Phase 2
Study type: Interventional

This is a phase 2, multicenter, open-label study to evaluate the efficacy of abivertinib with abiraterone in patients with metastatic castration-resistant prostate cancer.