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Prostate Cancer Metastatic clinical trials

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NCT ID: NCT06141993 Recruiting - Prostate Cancer Clinical Trials

ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials

ARCTIC
Start date: May 13, 2024
Phase:
Study type: Observational

This study will follow men with metastatic castration resistant prostate cancer throughout their standard of care treatment for their disease to determine if the presence of different genes or proteins can predict which patients respond to the cancer treatment they receive. As tumors grow and begin to spread, they may release cells into patients' bloodstream. These cells are called "circulating tumor cells", or CTCs. CTCs can be used to look for differences in "biomarkers" (genes or proteins that may change based on how a person is or is not responding to treatment). The purpose of this research study is to learn whether scientists can use biomarkers from CTCs to predict which tumors will respond to certain hormonal therapies. Participants will have blood collected and provide an archival sample from a previous tumor biopsy. The researchers will compare biomarkers from participants who responded well to treatment to those who responded poorly in order to answer the research question.

NCT ID: NCT06136624 Recruiting - Clinical trials for Prostate Cancer Metastatic

Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)

Start date: December 31, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) and to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria In Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS and rPFS per PCWG Modified RECIST 1.1 as assessed by BICR in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.

NCT ID: NCT05679388 Recruiting - Prostate Cancer Clinical Trials

A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients

Start date: February 13, 2023
Phase: Phase 1
Study type: Interventional

Researchers leading this study hope to learn about the safety of combining the study drug relugolix with another study drug called itraconazole or ritonavir in prostate cancer. This study is for individuals who have advanced prostate cancer and plans to have medical castration (the use of medications or chemicals to lower hormone production in the testicles). Your participation in this research will last up to 1 month. The purpose of this research is to gather information on the safety and effectiveness of relugolix in combination with ritonavir or itraconazole. The goal of this research is to find out if combining two medications (relugolix and itraconazole or relugolix and ritonavir) could possibly lead to using less relugolix, which is an expensive drug.

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 Terminated - 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