A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer
NCT05125016 · Metastatic Castration-resistant Prostate Cancer
RecruitingThis study is researching an investigational drug called REGN4336. Some participants may receive additional investigational drugs in combination with REGN4336. These additional drugs include REGN5678, cemiplimab and sarilumab. The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug) and effectiveness of REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678. REGN4336, cemiplimab and REGN5678 are a type of treatment for cancer called immunotherapy,and are intended to activate T-cells to attack cancer cells. This study has 2 parts. The purpose of Part 1 is to determine a safe dose of REGN4336 when given alone or when given in combination with cemiplimab or REGN5678. The purpose of Part 2 is to use the REGN4336 dose(s) determined in Part 1 to further test how well REGN4336 works to shrink tumors either when given alone or in combination with cemiplimab or REGN5678. This study is looking at several other research questions, including: * What side effects may happen from taking REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678? * How much REGN4336 is in the blood at different times when it is given alone, in combination with cemiplimab, or in combination with REGN5678? * Does the body make antibodies against the study drugs (REGN4336, cemiplimab, or REGN5678)?
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePalo Alto, California, United States + 13 more
SponsorRegeneron Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Adaptive Radiation Therapy for Men With Intermediate- or High-Risk Prostate Cancer
NCT07219303 · Prostate Cancer (Adenocarcinoma)
RecruitingThe goal of this clinical trial is to evaluate if adaptive stereotactic body radiation therapy (SBRT) is a safe and effective way to treat prostate cancer in adults. It will assess the safety profile of adaptive SBRT over time. The main questions this trial aims to answer are: * What is highest dose of adaptive SBRT without causing serious side effects? * Can adaptive SBRT more precisely targeting the prostate while reducing radiation exposure to nearby organs? * What side effects do participants experience during treatment, right after treatment, and over the five years post-treatment? * Can adaptive SBRT reduce urination-related side effects and support quality of life during and after treatment? Participants will: * Receive adaptive SBRT treatment every other day, for a total of 5 treatment sessions (called fractions). The full course of treatment typically takes 2 to 3 weeks. * Have a follow-up phone call about 6 weeks after treatment to check on side effects and overall wellbeing. * Visit the clinic for check-ups and tests: * At 90 days (about 3 months) after treatment * Then every 3 months for the first year * Then every 6 months after that
PhaseNA
TypeInterventional
Age18 Years
WherePhiladelphia, Pennsylvania, United States
SponsorFox Chase Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Pasritamig Versus Placebo in Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)
NCT07164443 · Metastatic Castration-resistant Prostate Neoplasms
RecruitingThe purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in combination with best supportive care (BSC) as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).
PhasePhase 3
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 162 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer
NCT06457919 · Prostate Cancer
RecruitingThe purpose of this study is to find out whether tinengotinib in combination with abiraterone acetate and prednisone or enzalutamide is a safe treatment that causes few or mild side effects in people with metastatic castration-resistant prostate cancer (mCRPC).
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereNew Haven, Connecticut, United States + 11 more
SponsorMemorial Sloan Kettering Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Carboplatin or Olaparib for BRcA Deficient Prostate Cancer
NCT04038502 · Metastatic Castrate Resistant Prostate Cancer, BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D, or RAD54L Mutations
RecruitingThis is an unblinded, randomized clinical study comparing the efficacy of DNA damaging chemotherapy using carboplatin, to standard of care therapy for patients who have metastatic castrate resistant prostate cancer. This trial will use olaparib or carboplatin as initial therapy with crossover to the alternate or second-line drug after first progression for patients with tumors containing BARD1, BRCA1, BRCA2, BRIP1, CHEK1, FANCL, PALB2, RAD51B, RAD51C, RAD51D, or RAD54L inactivating mutations. Participants are randomized (1:1) and receive either carboplatin (AUC 5, IV) every 21 days, first or olaparib taken orally (300 mg), twice daily in 28 day cycles, until intolerance, complete response, or progression by Prostate Cancer Working Group 3 (PCWG3) criteria. Participants then crossover from the first-line therapy to the second-line therapy with the opposite study medication and receive treatment to intolerance or progression (whichever is first). Enrolled participants will be allowed to crossover to second line therapy if they continue to meet initial eligibility criteria, and at least three weeks have elapsed since last administration of either carboplatin or olaparib. Throughout the study, safety and tolerability will be assessed. Progression will be evaluated with bone scan, CT of the abdomen/pelvis, or MRI and PSA as per PCWG3 criteria.
PhasePhase 2
TypeInterventional
Age18 Years
WhereWest Los Angeles, California, United States + 17 more
SponsorVA Office of Research and Development
▾Tap for detailsClick for full details — eligibility, all locations, contacts TERPS Trial for de Novo Oligometastic Prostate Cancer
NCT05223803 · Prostate Cancer, Oligometastatic Disease
RecruitingThis research is being done to see if we can improve the outcome of prostate cancer patients who present with metastatic lesions at initial diagnosis.
PhasePhase 2
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 8 more
SponsorUniversity of Maryland, Baltimore
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas
NCT04104776 · Advanced Solid Tumor, Diffuse Large B Cell Lymphoma, Lymphoma, T-Cell
RecruitingThe purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, and preliminary clinical activity of Tulmimetostat as a monotherapy in patients with advanced solid tumors and lymphomas.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereAtlanta, Georgia, United States + 59 more
SponsorNovartis Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer
NCT05818683 · Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
RecruitingThe purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion).
PhasePhase 1
TypeInterventional
Age18 Years
WhereSarasota, Florida, United States + 14 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Extending Prostate Genetic Awareness, Navigation, and Delivery: The EXPAND Network
NCT05627219 · Metastatic Prostate Carcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
RecruitingThis trial evaluates whether a network of peer genetic coaches is useful for addressing disparities in genetic testing and screening among African American men with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). While genetic testing has become central to prostate cancer care, African American men are less likely seek testing due to lack of awareness, cultural beliefs, financial limitations, fear of discrimination, and mistrust in the healthcare system. A network of peer genetic coaches may help address barriers, beliefs, and needs of African American men in the community and provide navigation to increase engagement in genetic testing.
Phase—
TypeObservational
Age18 Years
WherePhiladelphia, Pennsylvania, United States
SponsorThomas Jefferson University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
NCT06778863 · Advanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.
PhasePhase 1
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 20 more
SponsorClasp Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer
NCT05804318 · Prostate Cancer
RecruitingThis trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.
PhaseNA
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 6 more
SponsorVarian, a Siemens Healthineers Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy
NCT07234968 · Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma
RecruitingSubjects will be randomized into 2 groups (stent or no stent) prior to radical cystectomy with ileal conduit urinary diversion (RCIC). They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.
PhaseNA
TypeInterventional
Age18 Years – 85 Years
WherePhiladelphia, Pennsylvania, United States + 1 more
SponsorThomas Jefferson University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors
NCT03972657 · Metastatic Castration-Resistant Prostate Cancer (mCRPC), Clear Cell Renal Cell Carcinoma (ccRCC)
RecruitingThe main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab. The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors. This study is looking at several other research questions, including: 1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab 2. How REGN5678 alone or in combination with cemiplimab works in the body 3. How much REGN5678 and/or cemiplimab are present in the blood 4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 20 more
SponsorRegeneron Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
NCT06120491 · Metastatic Castration-Sensitive Prostate Cancer
RecruitingThe intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
PhasePhase 3
TypeInterventional
Age18 Years – 130 Years
WhereChandler, Arizona, United States + 409 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Tarlatamab for People With Prostate Cancer
NCT07111507 · Metastatic Prostate Cancer
RecruitingThe researchers are doing this study to find out whether tarlatamab is an effective treatment for Delta-like Protein 3 (DLL3)-positive prostate cancer that has spread to other parts of your body (metastasized) and has either come back after treatment (relapsed) or not responded to treatment (refractory).
PhasePhase 2
TypeInterventional
Age18 Years
WhereSan Diego, California, United States + 9 more
SponsorMemorial Sloan Kettering Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts International Registry for Men With Advanced Prostate Cancer (IRONMAN)
NCT03151629 · Prostate Cancer
RecruitingOur intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices. Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment and every three months thereafter. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance.
Phase—
TypeObservational
Age21 Years
WhereBirmingham, Alabama, United States + 120 more
SponsorProstate Cancer Clinical Trials Consortium
▾Tap for detailsClick for full details — eligibility, all locations, contacts Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation
NCT05487846 · Metastatic Prostate Carcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
RecruitingThis clinical trial evaluates whether having a trained peer navigator helps African American men with prostate cancer that has spread to other parts of the body (metastatic) understand and navigate the genetic testing process better than not having a peer navigator. Genetic testing for men with prostate cancer is very important for making treatment and management decisions. However, understanding the risks, benefits, and steps of genetic counseling and testing can be very challenging for patients. African American men are especially less likely to participant in genetic testing due to lack of awareness or understanding, cultural beliefs, finances, or mistrust of the healthcare system. A peer navigator, someone who helps a patient through the information and the process, may be helpful to some men. This study evaluates whether having a peer navigator throughout the genetic evaluation process helps patients understand and engage in the process more.
PhaseNA
TypeInterventional
Age18 Years
WherePhiladelphia, Pennsylvania, United States
SponsorThomas Jefferson University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
NCT03678025 · Castration Levels of Testosterone, Metastatic Prostatic Adenocarcinoma, Stage IV Prostate Cancer AJCC v8
RecruitingThis phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.
PhasePhase 3
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 337 more
SponsorSWOG Cancer Research Network
▾Tap for detailsClick for full details — eligibility, all locations, contacts RSSearch Patient Registry-Long Term Study of Use of SRS/SBRT
NCT01885299 · Neoplasms, Arteriovenous Malformation of Central Nervous System, Trigeminal Neuralgia
RecruitingThe RSSearch® Registry is an international multi-year database designed to track SRS/SBRT (Stereotactic Radiosurgery/Stereotactic Body Radiation Therapy) utilization, treatment practices and outcomes to help determine, over time, the most effective use of these systems in management of patients with life threatening tumors and other diseases. (This study was formally called ReCKord and included the CyberKnife only; The ReCKord study continues as a CyberKnife subset of RSSearch.)
Phase—
TypeObservational
AgeAny
WhereColorado Springs, Colorado, United States + 12 more
SponsorThe Radiosurgery Society
▾Tap for detailsClick for full details — eligibility, all locations, contacts TmPSMA-02 in mCRPC
NCT06046040 · Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
RecruitingThis is a Phase I, open-label dose finding study to assess the safety, tolerability, manufacturing feasibility, and preliminary efficacy of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer (mCRPC). Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.
PhasePhase 1
TypeInterventional
Age18 Years
WherePhiladelphia, Pennsylvania, United States
SponsorUniversity of Pennsylvania
▾Tap for detailsClick for full details — eligibility, all locations, contacts