Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
RecruitingThis study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs? This study would like to find out if this approach is better or worse than the usual approach for prostate cancer. The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).
PhasePhase 3
TypeInterventional
Age18 Years
WhereAnchorage, Alaska, United States + 394 more
SponsorCanadian Cancer Trials Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
RecruitingThis study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.
PhasePhase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 47 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts 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 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 Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
NCT05422911 · Metastatic Cancer, Neoplasm, Prostate, Castrate-sensitive
RecruitingThe investigators have used national VHA data to demonstrate real-world efficacy of abiraterone and enzalutamide in Veterans with mCRPC. In the real-world that is the VHA, the investigators have successfully estimated g values that accurately predict OS and the use of this metric in other settings should now be explored. In the egalitarian system that is the VHA the treatment of prostate cancer is excellent and uniform across the US. The choices made are clearly personalized, given not all men received all therapies and that younger Veterans were treated more aggressively. But with survivals that rival those in registration trials that enroll optimally fit individuals usually not encumbered by the co-morbidities that afflict many Veterans, the outcomes are testimony to the fact that for this common malady of older Veterans with whom VA physicians have broad experience the care administered is unsurpassed. Importantly this care at least as regards Veterans with mCRPC demonstrates that given equal access to health care, all men with prostate cancer fare comparably well. As our sophistication in categorizing cancers molecularly has increased this study will look to better examine any emerging differences across study participants.
PhasePhase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 11 more
SponsorSun Pharmaceutical Industries Limited
▾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 The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors or in participants with familial adenomatous polyposis (FAP).
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 32 more
SponsorParabilis Medicines, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Longitudinal Advanced Prostate Cancer Cohort (LAPCC)
NCT06067295 · Prostate Carcinoma
RecruitingThis study examines information from patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). By collecting biological samples (like blood, urine, and tissue), and health information (such as treatment, diet, and quality of life) researchers hope to learn more about prostate cancer and ways to improve outcomes in the future.
Phase—
TypeObservational
Age18 Years
WhereLos Angeles, California, United States + 1 more
SponsorUniversity of Southern California
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mechanisms of Resistance to PSMA Radioligand Therapy
RecruitingThis is a multicenter, correlative study to existing Lutetium based prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) trials and uses.
Phase—
TypeObservational
Age18 Years
WhereLos Angeles, California, United States + 2 more
SponsorUniversity of California, San Francisco
▾Tap for detailsClick for full details — eligibility, all locations, contacts HIFU for Focal Ablation of Prostate Tissue: An Observational Study
RecruitingThe Sonablate HIFU device was approved by the U.S.FDA for prostate tissue ablation in October, 2015. The purpose of this observational research study is to investigate the localized treatment of prostate cancer using HIFU through clinical data and health-related quality of life (HRQOL) questionnaires.
Phase—
TypeObservational
Age40 Years – 85 Years
WhereLos Angeles, California, United States
SponsorUniversity of California, Los Angeles
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
RecruitingThis study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.
PhasePhase 3
TypeInterventional
Age18 Years
WhereChandler, Arizona, United States + 235 more
SponsorPfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
NCT04787744 ·
Prostate Cancer, Oligometastasis, Oligorecurrence
RecruitingThis is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WhereLong Beach, California, United States + 19 more
SponsorVA Office of Research and Development
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Oral MRT-2359 With Apalutamide in Prostate Cancer
RecruitingThis Phase 2, open-label, multicenter study is conducted in patients with castration-resistant prostate cancer. Patients in this study receive MRT-2359, an investigational oral medicine, in combination with apalutamide, an oral medicine used to treat prostate cancer. The main purpose of the study is to assess whether this treatment combination can lower prostate-specific antigen (PSA) The study will also evaluate the safety and tolerability of the treatment combination and assess additional measures of anti-tumor activity.
PhasePhase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 13 more
SponsorMonte Rosa Therapeutics, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts PSMA PET Combined With MRI for the Detection of PCa
NCT07052214 · PCA,
Prostate Cancer, Prostatic Neoplasm
RecruitingThis is an open label, longitudinal Phase 3 study of prostate specific membrane antigen (PSMA) positron emission tomography (PET) combined with magnetic resonance imaging (MRI) compared to standard of care (SOC) for the detection of prostate cancer (PCa).
PhasePhase 3
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 17 more
SponsorTelix Pharmaceuticals (Innovations) Pty Limited
▾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 Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
NCT06056830 ·
Prostate Cancer, Prostatic Neoplasms
RecruitingThe aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 30 more
SponsorClarity Pharmaceuticals Ltd
▾Tap for detailsClick for full details — eligibility, all locations, contacts Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity
RecruitingSingle-arm, prospective registry study assessing changes in acute patient-reported urinary (GU) and gastrointestinal (GI) quality of life at the 24-month post-treatment time point following magnetic resonance imaging (MRI)-guided or computed tomography (CT)-guided stereotactic body radiotherapy (SBRT) delivered to the prostate bed +/- pelvic lymph nodes. The decision to offer an adaptive treatment will be at the clinician's discretion.
Phase—
TypeObservational
Age18 Years
WhereLos Angeles, California, United States
SponsorJonsson Comprehensive Cancer Center
▾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 A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
NCT05751434 ·
Prostate Cancer, Prostate Adenocarcinoma, Localized Prostate Carcinoma
RecruitingTo determine the effects of exercise therapy on molecular, radiologic, and pathologic nimbosus hallmarks versus usual care control in men on Active Surveillance for localized prostate cancer.
PhasePhase 2
TypeInterventional
Age18 Years
WhereDurate, California, United States + 9 more
SponsorCity of Hope Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc
RecruitingThis trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.
PhasePhase 2
TypeInterventional
Age18 Years
WhereWest Los Angeles, California, United States + 3 more
SponsorVA Office of Research and Development
▾Tap for detailsClick for full details — eligibility, all locations, contacts