Clinical Studies for Genitourinary Oncology

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Title: AcTFirst: A phase III, open-label, multi-center, randomized study comparing AAA817+ARPI versus standard of care in adult participants with PSMA-positive metastatic castration resistant prostate cancer
Brief Title: Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
Brief Summary: The purpose of this study is to determine whether [225Ac]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or [177Lu]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.
For info regarding 26-078 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Phase 1, Multicenter Trial Evaluating the Safety, Tolerability, and Efficacy of Valemetostat (DS-3201) in Combination with Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Brief Title: A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
Brief Summary: This study will assess the safety and tolerability of valemetostat in combination with darolutamide in participants with Metastatic Castration Resistant Prostate Cancer (mCRPC).
For info regarding 26-061 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: PSMAcTION: A phase II/III, open-label, international, multi-center, randomized study of AAA817 versus standard of care in the treatment of adult participants with PSMA-positive metastatic castration-resistant prostate cancer who progressed on or after [177Lu]Lu-PSMA targeted therapy.
Brief Title: Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy
Brief Summary: This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after [177Lu]Lu-PSMA targeted therapy. Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment
For info regarding 25-167 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer
Brief Title: Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Brief Summary: This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.
For info regarding 24-138 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Debunking the Frailty-sarcopenIa-ADT axis in mEtastatic prostate canceR with multiComponent Exercise: The FIERCE Trial
Brief Title: Debunking the Frailty-sarcopenIa-ADT Axis in mEtastatic Prostate canceR With multiComponent Exercise: The FIERCE Trial
Brief Summary: The purpose of this study is to determine whether a 16-week supervised, clinic-based circuit training intervention utilizing resistance and functional exercises and self-directed aerobic exercise will improve frailty and sarcopenic status and disease progression outcomes among pre-frail/frail metastatic prostate cancer patients receiving androgen deprivation therapy (ADT). The names of the study intervention involved in this study is: • Supervised circuit training (aerobic and resistance exercise regimen)
For info regarding 23-109 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Exercise to Enhance Cardiovascular Health among Black Prostate Cancer Patients with Androgen Deprivation Therapy: POWER Trial
Brief Title: Exercise to Enhance Cardiovascular Health Among Black Prostate Cancer Patients With Androgen Deprivation Therapy
Brief Summary: 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.
For info regarding 21-741 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: A Phase 2 Multicohort Study of Nivolumab in Combination with Docetaxel and Androgen Deprivation Therapy in Metastatic Hormone Sensitive Prostate Cancer Patients with DNA Damage Repair Defects or Inflamed Tumors
Brief Title: Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors
Brief Summary: This research study is studying a combination of hormonal therapy, chemotherapy, and immunotherapy as a possible treatment for metastatic hormone-sensitive prostate cancer. The names of the study drugs involved in this study are: - Androgen deprivation therapy (ADT) with a drug of your physician's choice. This may include leuprolide (Lupron), goserelin acetate (Zoladex), or degarelix (Firmagon). - Docetaxel - Nivolumab
For info regarding 19-384 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Clinicopathological, immunohistochemical, and molecular characterization of renal cell carcinoma.
Brief Title: CLINICOPATHOLOGICAL, IMMUNOHISTOCHEMICAL, AND MOLECULAR CHARACTERIZATION OF RENAL CELL CARCINOMA
For info regarding 17-271 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu
 
Title: Study of Microtubule Bundling as a Marker of Taxance Activity in Patients with mCRPC
Brief Title: Study of Microtubule Bundling as Marker of Taxance Activity in pts w mCRPC
For info regarding 13-368 please contact Cancer Clinical Trials at 617-975-7403 or cancerclinicaltrialsinfo@bidmc.harvard.edu