1,075 Clinical Trials for Various Conditions
The purpose of this study is to collect prostate cancer tissue from males with metastatic prostate cancers in order to study the tumor microenvironment (TME), which is the area surrounding the tumor including cells, blood vessels, etc., in men with metastatic prostate cancer. The type of research performed on these tissue samples include genetic \& molecular analyses.
This study will assess different doses and regimens of radium-223 dichloride on the incidence of symptomatic skeletal events. Eligible subjects must have castration resistant prostate cancer with 2 or more skeletal metastases documented within 8 weeks of randomization. Subjects will be randomized to one of 3 treatment arms in a 1:1:1 fashion: a standard regimen of radium-223 dichloride of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 6 months, a high dose regimen of 80 kBq/kg (88 kBq/kg after implementation of NIST update)injections every month for 6 months or an extended duration regimen of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 12 months. Following the treatment phase, subjects will be followed up every 12 weeks for a minimum of 2 years, at which point they will enter a long term follow-up period during which they are seen every 6 months for up to 7 years after the last dose of radium dichloride. Symptomatic skeletal event and safety endpoints will be assessed at each clinic visit. Pain and analgesic use data will be collected every 4 weeks through Week 48. Additionally, radiological assessments including MRI/CT of the abdomen and pelvis and chest CT, as well as technetium-99 bone scans will be performed at Weeks 8, 16, and 24 and continue every 12 weeks thereafter until disease progression is documented in either the bone or in soft tissue. Radiological imaging will be evaluated by blinded central review.
The purpose of this study is to look at the effects of cabozantinib on castrate-resistant prostate cancer metastatic (cancer that has spread to other parts of the body) to the bone and to learn about any side effects caused by taking cabozantinib.
The main purpose of this study is to look at the effects (good or bad) that Atrasentan given alone and Atrasentan given with Zometa has on levels of bone formation and bone destruction in men with prostate cancer that has spread to the bones.
Assessment of the safety and efficacy of HLD-0915 as monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC) that have progressed on prior systemic therapies, once a recommended dose for expansion (RDE) has been determined in Phase 1 of the trial.
There is a well-documented association between androgen deprivation therapy (ADT) and cardiovascular morbidity. A majority of men on ADT gain weight contributing to an increase in cardiovascular risk factors (CVRFs) and cardiovascular morbidity. Dietary intervention combined with exercise have shown success in reducing weight/fat mass and improving cardiovascular risk factors (CVRF). There is little data on whether African American men would respond to diet and exercise interventions differently from non-Hispanic white men. We will conduct a pilot, controlled two-phase intervention study stratified by race to investigate the following objectives: 1. Compare effect of a hypocaloric, anti-inflammatory diet on changes in fat mass between African- American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy. 2. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cardiovascular risk factors (body weight, lean body mass, waist-to-height ratio, blood pressure, lipids and HbA1C) and inflammatory markers (hs-CRP and cytokines) between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy. 3. Compare effect of a hypocaloric, anti-inflammatory diet on changes in cancer-related fatigue and quality of life between African-American vs non-Hispanic white men with metastatic prostate cancer on ADT therapy. We will enroll 35 African American and 35 non-Hispanic white men with prostate cancer undergoing ADT therapy. In phase 1, after baseline assessment, men will consume their habitual diet and continue their habitual activity level for 3 months. During phase 2, participants will be instructed to consume a hypocaloric (-500 kcal), anti- inflammatory diet and walk for 1 hour on 3 days per week for 3 months. At baseline, after phase 1 and 2 primary outcome (fat mass) and secondary outcomes (CVRF and inflammatory markers) and tertiary outcomes (cancer-related fatigue and quality of life) will be determined.
The goal of this clinical trial is to gain more information about how FAPI (fibroblast activation protein inhibitor) binds to certain type of cells in the tumor tissue. The main question it aims to answer is how this information can be used to better diagnose and track prostate cancer. Participants will undergo two PET/MRI scans during two research visits, each of which may last up to 2.5 hours.
Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.
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.
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.
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.
Phase 1b study to assess the combination of ARV-110 and abiraterone in patients with metastatic prostate cancer with rising PSA values on abiraterone.
This study aims to examine the use of high-intensity interval training (HIIT) and resistance training on docetaxel chemotherapy tolerability and toxicity in metastatic prostate cancer.
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.
Eligible patients will be treated with the combination of lenvatinib and pembrolizumab. A cycle equals 21 days and therapy will continue until radiographic progression, intolerable toxicity, or patient/physician wishes to discontinue protocol therapy. A maximum of 35 cycles may be administered. On Day 1, when both pembrolizumab and lenvatinib are administered, patients should take the lenvatinib per their normal routine.
The purpose of this research is to test the effectiveness of an experimental drug combination for people with metastatic castration-resistant prostate cancer (mCRPC). The names of the study drugs involved in this study are: * Telaglenastat (CB-839) * Talazoparib
This is a multicenter phase 2b study to evaluate the efficacy and tolerability of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer, suitable for treatment with a taxane.
The primary objective is to determine the safety and activity of combined hormonal chemoimmunotherapy in a single-arm phase II trial of REGN2810, androgen deprivation therapy (ADT), and docetaxel in patients with newly metastatic, hormone-sensitive prostate cancer (mHSPC), using a primary endpoint of undetectable prostate-specific antigen (PSA) at 6 months, defined from start of combination therapy (week 10) until 6 months (week 37).
Phase 1/2 dose escalation study to assess the safety and tolerability of ARV-110 in men with mCRPC who have progressed on prior approved systemic therapies for their castrate resistant disease (one of which must be enzalutamide or abiraterone).
This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic or mildly symptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC). The following assessment of prostate cancer status will be collected during the course of the trial: soft tissue disease on computed tomography (CT) scan or on magnetic resonance imaging (MRI), bone disease on radionuclide bone scans, FACT-P and EQ-5D, Brief Fatigue Inventory, and PSA. Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs and physical examinations, safety laboratory evaluations, and 12-lead electrocardiograms (ECGs). Blood samples for population pharmacokinetics for HC-1119 and enzalutamide and related metabolites will be collected.
The investigators are conducting this study with men that have prostate cancer and are getting standard of care treatment with the drugs abiraterone acetate and prednisone. The study will follow men with prostate cancer from initiation of participation in the study and for up to 10 years. The reason for the study is that researchers think that there may be a connection between the race and ethnicity of men with prostate cancer and how well the standard treatments work for the participants.
Randomized, double-blind, placebo controlled, dose finding Phase 2 study comparing oral daily dosing of VERU-944 after a week of loading (daily dosing) with placebo to ameliorate the vasomotor symptoms resulting from androgen deprivation therapy in men with advanced prostate cancer
This study will test the safety and efficacy of FOR46 given every 21 days to patients with metastatic castration-resistant prostate cancer. The name of the study drug involved in this study is: FOR46 for Injection (FOR46)
This was an open-label, multicenter, single dose, Phase I/II study to evaluate the safety and tolerability of a single administration of 3 mega Becquerel (MBq)/kg, but not less than 150 MBq and not more than 250 MBq, of 68\^Ga-PSMA-R2 in adult male patients with biochemical relapse (BR) and metastatic prostate cancer (mPCa).
The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.
This is a Long Term Follow Up study to eRADicAte, an open label study designed to examine the effects of Radium Ra 223 dichloride with concurrent administration of Abiraterone Acetate plus Prednisone Castrate-Resistant (Hormone-Refractory) Prostate Cancer subjects with symptomatic bone metastasis.
The aim of this research is to find out if the study drug rucaparib leads to lowering of PSA levels in men with metastatic prostate cancer that has not yet been treated with androgen deprivation therapy (also referred to as metastatic hormone sensitive prostate cancer) and who have an inherited mutation in a gene involved in repairing DNA damage. The research will also examine if rucaparib is safe in individuals with metastatic prostate cancer. Prior research studies have shown that drugs like rucaparib can be of benefit to patients with advanced metastatic prostate cancer who are resistant to androgen deprivation therapy AND who carry a mutation in a DNA repair gene. We are studying if rucaparib will be an effective treatment for these patients earlier in their treatment course (for example, prior to the start of medicines that lower testosterone level). It is unknown whether rucaparib will have the same benefit in men with metastatic prostate cancer carrying a mutation in a DNA repair gene, prior to the use of medicines that lower your testosterone level.
This is a phase IIa, open label, single arm, and prospective study of hormone therapy-naïve men with oligometastatic prostate cancer to the bone. The study will test if treating the primary tumor sites and 5 or fewer sites of bone-only metastasis with external beam radiation with concomitant systemic Radium-223 will reduce the utilization of androgen deprivation therapy, improve QOL and improve OS over a the comparator cohort of SWOG intermittent ADT historic cohort.
The purpose of the study is to compare the safety and tolerability of sequential atezolizumab followed by sipuleucel-T (Arm 1) vs. sipuleucel-T followed by atezolizumab (Arm 2) in patients who have asymptomatic or minimally symptomatic metastatic CRPC, not previously treated with docetaxel or cabazitaxel.
This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a 1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.