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An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. (PSMA-DC)
Rochester, MN
The purpose of this study is to evaluate the effectiveness of AAA617 versus observation after Stereotactic Body Radiation Therapy (SBRT), in delaying castration or disease recurrence in adult patients with PSMA
positive OMPC with 1 to 5 metastatic lesions detected by PSMA PET using gallium (68Ga) gozetotide or piflufolastat (18F), negative for M1 disease by conventional imaging (CI).
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International Registry for Men With Advanced Prostate Cancer (IRONMAN)
Jacksonville, FL
The purpose of this registry is to collect detailed clinical, epidemiological and biological information from 5,000 male patients with advanced prostate cancer.
The objectives are to describe the practice patterns of therapeutic agents for treatment of advanced prostate cancer internationally; to assess whether specific treatment patterns are associated with clinically significant adverse events, and evaluate potential interactions with concomitant medications or demographic factors; to identify associations between treatment sequences or combinations and overall survival; to define the patient experience of men with advanced prostate cancer and identify unmet needs in their treatment; and to identify clinical and molecular disease subtypes that predict response to individual treatments, combinations, or sequences.
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Stereotactic Body Radiotherapy Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if salvage stereotactic body radiotherapy (SBRT) is non-inferior to moderately hypofractionated radiation therapy (HFRT) regarding treatment related rates of genitourinary (GU) and gastrointestinal (GI) Grade 3 or higher within 2-years.
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XmAb®20717 Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to investigate the safety and clinical activity of XmAb20717 alone or in combination with standard of care anticancer therapies in patients with metastatic castration-resistant prostate cancer (mCRPC) who have been treated with at least 2 prior lines of anticancer therapy.
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Understanding Financial Toxicity in Management of Advanced Prostate Cancer from Qualitative Approach
Rochester, MN
The purpose of this study is to identify characteristics of financial toxicity unique to advanced prostate cancer, especially those areas not assessed through current objective measures, and describe how can these areas inform potential interventions to ameliorate financial toxicity.
This aim will be accomplished through qualitative focus group study of advanced prostate cancer patients who exhibit both extremes of financial toxicity. Findings will be presented in a joint display with quantitative survey data obtained in a prior study.
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CJNJ-67652000 and Prednisone for the Treatment of Men With Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000 [niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and who have a mutation in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is a drug which stops certain cancer cells from being able to repair themselves from damage, leading to the death of the cancer cell. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response ...
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Radiation Therapy With or Without Apalutamide in Treating Patients With Stage III-IV Prostate Cancer
Albert Lea, MN
The purpose of this study is to determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation therapy (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
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Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer, TraPPer Study
Rochester, MN
This phase II trial tests how well pertuzumab, trastuzumab, hyaluronidase-zzxf and enzalutamide works in treating patients with castration-resistant prostate cancer that has spread from where it first started to other places in the body (metastatic). Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called human epidermal growth factor receptor-2 (HER2). HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an ...
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AZD5305 vs Placebo in Men with Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to demonstrate superiority of AZD5305 + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
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Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of part one of this study is to determine the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and safety profile of Q901 monotherapy when administered via intravenous (IV) infusion once-weekly (QW) for 4 weeks and once every 2 weeks (Q2W) thereafter. Also, to establish for future clinical development the recommended Phase 2 dose (RP2D) of Q901 monotherapy when administered via IV infusion QW for 4 weeks and Q2W thereafter.
The purpose of part two of this study is to evaluate safety and tolerability and evidence of anticancer activity of Q901 as monotherapy and in combination with pembrolizumab. In Part 2 Cohort 1, ...
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Tele-Medicine in an Advanced Prostate Cancer Clinic
Rochester, MN
The purpose of this study is to describe the use of tele-medicine during the COVID-19 pandemic in our advance prostate cancer practice and evaluate patient satisfaction.
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Study of E7386 in Participants With Selected Advanced Neoplasms
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to assess the safety/tolerability profile of E7386 as a single agent administered orally in participants with selected advanced or recurrent neoplasms and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of E7386.
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A Study of CDX-1127 (Varlilumab) in Patients with Select Solid Tumor Types or Hematologic Cancers
Scottsdale/Phoenix, AZ; Rochester, MN
This is a study of CDX-1127, a therapy that targets the immune system and may act to promote anti-cancer effects. The study enrolls patients with hematologic cancers (certain leukemias and lymphomas), as well as patients with select types of solid tumors.
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Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
Rochester, MN
The purpose of this study is to find out more about the side effects of rovalpituzumab tesirine (SC16LD6.5) and what doses of rovalpituzumab tesirine (SC16LD6.5) are safe for people with specific delta-like protein 3-expressing cancers.
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A Study to Evaluate Exercise for Cancer Patients at Risk of Falling
Rochester, MN
The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.