A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer
RecruitingMedicines that reduce the amount of testosterone in the body are commonly used to treat prostate cancer. PRL-02 depot is a potential treatment for men with advanced prostate cancer. It is given by an injection into the muscle. Men with advanced prostate cancer can take part in this study. Their cancer has come back after previous cancer treatment, or the previous cancer treatment they had didn't work. The main aims of the study are: * to check the safety of PRL-02 depot given with and without another medicine called enzalutamide. * to check if the men can tolerate PRL-02 depot given with or without enzalutamide. * to find a suitable dose of PRL-02 depot. This study will be in 2 parts. In the first part, different small groups of men will receive lower to higher doses of PRL-02 depot together with other medicines. In the second part of the study, men who have previously taken a hormone therapy called abiraterone acetate or have previously taken 1 specific hormone therapy as part of their prostate cancer treatment can take part. Men in both parts of the study will receive injections of PRL-02 depot into a muscle once every 12 weeks. They will also take dexamethasone or prednisone, or enzalutamide once a day. The other medicines they take depend on which group and which part of the study they are in. During the study, the men will visit the clinic several times for health checks and scans. After the final visit, men whose cancer has not become worse will continue to have health checks and scans every few months.
PhasePhase 1
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 24 more
SponsorAstellas Pharma Global Development, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors
NCT07517198 · Solid Tumor,
Small Cell Lung Cancer (SCLC), High Grade Neuroendocrine Cancer
RecruitingThe primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 2 more
SponsorExscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, 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 Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors
RecruitingThe objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects with locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms
PhasePhase 1
TypeInterventional
Age18 Years
WhereHuntsville, Alabama, United States + 23 more
SponsorSystImmune Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts PSMA PET Response Guided SabR in High Risk Pca
NCT06044857 · Prostate Adenocarcinoma
RecruitingSequential cohort evaluation of ideal timing of imaging and treatment spacing to discern maximal PSMA (Prostate specific membrane antigen) PET (Positron Emission Tomography) response (PSMA-11 68Ga, Illucix) for adaptation of dominant intra-prostatic lesion tumor boost dose
PhasePhase 1
TypeInterventional
Age18 Years – 99 Years
WhereDallas, Texas, United States + 1 more
SponsorUniversity of Texas Southwestern Medical Center
▾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 This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 107 more
SponsorAlliance for Clinical Trials in Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
NCT05914116 · Advanced Solid Tumors
RecruitingThis is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 106 more
SponsorDualityBio Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC
RecruitingThis is a dose-finding study to assess the safety and preliminary antitumor activity of Pocenbrodib alone or with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC)
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereFountain Valley, California, United States + 18 more
SponsorPathos AI, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
RecruitingA phase 1a/1b, multicenter, open-label, dose escalation/expansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas
PhasePhase 1
TypeInterventional
Age18 Years
WhereDenver, Colorado, United States + 9 more
SponsorDren Bio
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
RecruitingThe purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).
PhasePhase 3
TypeInterventional
Age18 Years – 100 Years
WhereFayetteville, Arkansas, United States + 143 more
SponsorNovartis Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER)
RecruitingThis Phase II, single arm study evaluates a PSA-response-adapted approach to salvage radiotherapy after radical prostatectomy for prostate cancer. All participants will receive hypo-fractionated stereotactic radiotherapy to the prostate fossa. At 5 weeks, biochemical response will be assessed. responders will proceed to observation, while non responders will receive sequential pelvic nodal radiotherapy and 4 months of androgen deprivation therapy (ADT). The study aims to determine whether this response base approach achieves non inferior 2 year freedom from progression compared with historical outcomes using routine pelvic nodal radiotherapy and ADT in all patients.
PhasePhase 2
TypeInterventional
Age18 Years
WhereDallas, Texas, United States
SponsorUniversity of Texas Southwestern Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Outcomes of Focal Ablation for Prostate Cancer
RecruitingThis study will be designed to define the efficacy and safety of ablative therapies in the management of localized prostate cancer and comprehensively evaluate quality of life outcomes and oncologic control following treatment.
Phase—
TypeObservational
Age18 Years – 90 Years
WhereDallas, Texas, United States
SponsorUniversity of Texas Southwestern Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
RecruitingThis 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) 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 in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.
PhasePhase 3
TypeInterventional
Age18 Years
WhereOrange, California, United States + 287 more
SponsorMerck Sharp & Dohme LLC
▾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 Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
NCT03866382 · Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma, Bladder Mixed Adenocarcinoma
RecruitingThis phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 580 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.
RecruitingThis study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.
PhasePhase 3
TypeInterventional
Age18 Years
WhereHuntsville, Alabama, United States + 336 more
SponsorPfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of JANX014 in Subjects With Metastatic Castration-Resistant Prostate Cancer
RecruitingThis study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).
PhasePhase 1
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 5 more
SponsorJanux Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of LY4257496 in Participants With Cancer (OMNIRAY)
NCT07114601 · Breast Neoplasms, Colorectal Neoplasms, Prostate Neoplasm
RecruitingThe main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.
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 Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
NCT04423211 · Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma
RecruitingThis phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen \[PSA\] after surgical removal of the prostate cancer). A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested. Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAnchorage, Alaska, United States + 340 more
SponsorECOG-ACRIN Cancer Research Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts