Prostate Active Surveillance Study
NCT00756665 · Prostatic Neoplasms
RecruitingThe Prostate Active Surveillance Study (PASS) is a research study for men who have chosen active surveillance as a management plan for their prostate cancer. Active surveillance is defined as close monitoring of prostate cancer with the offer of treatment if there are changes in test results. This study seeks to discover markers that will identify cancers that are more aggressive from those tumors that grow slowly.
Phase—
TypeObservational
Age21 Years
WhereSan Francisco, California, United States + 10 more
SponsorUniversity of Washington
▾Tap for detailsClick for full details — eligibility, all locations, contacts Polygenic Risk Stratification Combined With mpMRI to Identify Clinically Relevant Prostate Cancer
NCT06398639 ·
Prostate Cancer, Polygenic Risk Score
RecruitingThe goal of this clinical trial is to evaluate a screening method to detect clinically relevant prostate cancer. This clinical trial is using genetic data to determine a man's risk of cancer, together with multiparametric magnetic resonance imaging (mpMRI) to identify men with higher grade cancer. The main questions it aims to answer are: * If genetic data related to prostate cancer used with MRI can identify higher-grade, potentially fatal prostate cancer * What age a MRI is useful clinically for prostate cancer screening * If deep learning methods used with MRI when the genetic risk of the man is known can more accurately predict significant cancers Participants will: * Get a prostate specific antigen (PSA) blood test * Get an mpMRI * Get the results of their genetic data to determine if they are considered high-, intermediate-, or low-risk for prostate cancer based on the trials genetic testing * Follow-up for this trial based on the participants risk and findings from the PSA test and mpMRI
PhaseNA
TypeInterventional
Age40 Years – 69 Years
WhereWashington D.C., District of Columbia, United States + 4 more
SponsorAdam S. Kibel, MD
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
RecruitingThe main objective of the trial is to evaluate the safety and tolerability of xaluritamig in combination with darolutamide or abiraterone.
PhasePhase 1
TypeInterventional
Age18 Years
WhereSan Francisco, California, United States + 13 more
SponsorAmgen
▾Tap for detailsClick for full details — eligibility, all locations, contacts This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of advanced prostate cancer that either has low prostate-specific membrane antigen (PSMA) expression or has neuroendocrine features. The name of the study interventions are: * 18F-fluciclovine-PET/CT scan * Two research blood collections
PhasePhase 1
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 1 more
SponsorBrigham and Women's Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts The purpose of this study is to assess detection rate of flotufolastat F 18 positron emission tomography (PET) for low prostate specific antigen (PSA) recurrence of prostate cancer (PC) following radical prostatectomy.
Phase—
TypeObservational
Age18 Years
WhereBoston, Massachusetts, United States + 1 more
SponsorMassachusetts General Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease, PATROL Study
NCT04472338 · Prostate Carcinoma
RecruitingThis study investigates ways to detect prostate cancer earlier in people at genetic risk for disease that forms, grows, or spreads quickly (aggressive). Studying samples of blood, urine, and/or tissue in the laboratory may help doctors further understand the genetics of prostate cancer and help identify ways to detect cancer earlier, thereby improving treatment and methods of early detection in the future.
Phase—
TypeObservational
Age40 Years
WhereDuarte, California, United States + 7 more
SponsorUniversity of Washington
▾Tap for detailsClick for full details — eligibility, all locations, contacts Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)
NCT07427043 · Opioid Consumption, Postoperative, Multimodal Analgesia, Robotic Assisted Laparoscopic Surgery
RecruitingThis prospective, interventional, open-label, phase 3 randomized study evaluates a multimodal analgesia discharge pathway to reduce automatic opioid prescribing following routine robotic-assisted laparoscopic prostatectomy (RALP). Patients are counseled on post-operative pain management and then may opt into or out of the study with randomization to discharge prescriptions including (A) multimodal plan with additional automatic opioid prescription or (B) multimodal plan alone and instruction to call phone line to request opioid prescription if pain management is insufficient. Additionally, a cohort of historical controls prior to implementation of the study is also prospectively assessed as a pre-study baseline. The primary outcome is postoperative opioid consumption. Secondary outcomes include bowel function recovery, unplanned care encounters including emergency department visits or postoperative phone calls, and same-day discharge rates.
PhasePhase 3
TypeInterventional
Age45 Years
WhereBoston, Massachusetts, United States + 1 more
SponsorBrigham and Women's Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Dual BET and CBP/p300 Inhibitor in Patients With Targeted Advanced Solid Tumors and Hematological Malignancies
RecruitingA Phase 1, first-in-human study of EP31670, a dual BET and CBP/p300 inhibitor in patients with targeted advanced solid tumors and Hematological Malignancies
PhasePhase 1
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 5 more
SponsorEpigenetix, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
NCT04373564 · Motor Function, Cognitive Function, Contrast Media
RecruitingThis study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA. The study aims to create detailed images of the organs and tissue of the human body during x-ray, CT-scan or MRI investigations, doctors are using contrast media (a kind of dye) which can be given to patients by injection into a blood vessel or by mouth. In this study researchers want to find out whether so called gadolinium-based contrast agents (GBCAs) have an effect on body movement and mental skills when given to participants multiple times within 5 years. The study plans to enroll about 2076 participants suffering from a condition for which they are likely to have at least annually a MRI or another imaging examinations. Only adults up to 65 years will be considered to join this study. During the study duration of 5 years participants will receive annually a MRI or other imaging tests (such as CT-scan, x-ray) and will visit the study doctor at least 7 times for physical examinations, laboratory investigations and tests on body movement and mental skills.
PhasePhase 4
TypeInterventional
Age18 Years – 64 Years
WhereScottsdale, Arizona, United States + 50 more
SponsorGuerbet
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
NCT06465069 · Metastatic Solid Tumor, Recurrent Solid Tumor, Advanced Solid Tumor
RecruitingThe purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 32 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
RecruitingThe objective of this study is to see if providing an appropriate therapy based on the genomic testing of prostate tumour tissue will result in an improved clinical response. Each participant will be treated with 8 weeks of a luteinizing hormone-releasing hormone agonist (LHRHa) plus apalutamide (APA) while genome sequence characterization is being done. Participants with biopsy specimens deemed unevaluable for genomic testing will remain on LHRHa plus APA for an additional 16 weeks. Participants with evaluable tissue will be assigned to one of the open-label sub-studies on the basis of genomic profiling results. Within each group, they will be randomized to a specific treatment arm either LHRHa plus APA alone or adding abiraterone acetate and prednisone, docetaxel or niraparib. The study will evaluate the response rate and outcomes after radical prostatectomy in each arm of the trial.
PhasePhase 2
TypeInterventional
Age18 Years
WhereSacramento, California, United States + 8 more
SponsorUniversity of British Columbia
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of AZD0754 in Participants With Metastatic Prostate Cancer
RecruitingThe purpose of this study is to evaluate the safety, tolerability, and antitumour activity of AZD0754 CAR T-cell therapy in participants with metastatic prostate cancer.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 130 Years
WhereDuarte, California, United States + 14 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts The purpose of this research study is to see how well an imaging test, called 18FDCFPyL prostate specific membrane antigen (PSMA) positron emission tomography (PET), can show the extent of prostate cancer when comparing to 68Ga-PSMA-11 PET/CT (another type of diagnostic scan for prostate cancer).
PhasePhase 4
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 1 more
SponsorBrigham and Women's Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
RecruitingTTX-080-001 is a Phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy (HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor), cetuximab (EGFR inhibitor) or FOLFIRI plus cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies including metastatic colorectal cancer (mCRC) patients.
PhasePhase 1
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 40 more
SponsorTizona Therapeutics, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
RecruitingThe purpose of this study is to learn about the safety and effects of the study medicine (called Mevrometostat) for the possible treatment of Relapsed/ Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL). The study consists of 3 parts; Part 1 and 2 enrolled participants with SCLC, metastatic CRPC, and FL are closed for enrollment. Part 3, which is open for enrollment is seeking men who: * have Castration Resistant Prostate Cancer (CRPC) and * have previously received treatment for CRPC and have progressed from the last treatment All participants in Part 3 of this study will receive mevrometostat and/ or enzalutamide. Part 3 consists of 2 sub studies each has an assessment phase and a maintenance phase. The Part 3 DDI substudy consist of 2 cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (Combination cohort). In the assessment phase: * participants in the BE substudy will take 3 single doses of mevrometostat by mouth over 3 periods. * participants in the DDI substudy Cohort 1 (monotherapy cohort) will take mevrometostat 2 times a day and/or itraconazole 1 time a day based on a present schedule. * participants in the DDI substudy Cohort 2 (combination cohort) will take mevrometostat 2 times a day, enzalutamide 1 time a day, and/or itraconazole 1 time a day based on a present schedule. After completion of the assessment phase, participants will enter the maintenance phase where they will receive mevrometostat 2 times a day and enzalutamide 1 time a day by mouth until their cancer is no longer responding. The study will look at the experiences of participanrs receiving the study medicine. This will help see if the study medicine is safe and effective.
PhasePhase 1
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 81 more
SponsorPfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
NCT06235151 ·
Prostate Cancer, Prostate Adenocarcinoma
RecruitingThis is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.
PhasePhase 3
TypeInterventional
Age18 Years
WhereLittle Rock, Arkansas, United States + 42 more
SponsorCurium US LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer
RecruitingThe main purpose of the study is to assess the safety and tolerability of AZD2284, AZD2287, and AZD2275.
PhasePhase 1
TypeInterventional
Age18 Years
WherePalo Alto, California, United States + 15 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts 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.
PhaseNA
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States
SponsorDana-Farber Cancer Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer
RecruitingThis study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD6621. The study is split into different modules which will look at AZD6621 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels of AZD6621 to determine which doses are the best in terms of safety and side effects (dose escalation), and Part B will further test at least two AZD6621 doses in a larger group of participants (dose expansion).
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereOrlando, Florida, United States + 24 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Jump: MR Simulation For Radiation Therapy Master Protocol
NCT04545957 ·
Prostate Cancer, Recurrent Adenocarcinoma, Liver Cancer
RecruitingThis is a master protocol for a prospective Phase I-II study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatments.
PhaseNA
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 1 more
SponsorBrigham and Women's Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts