Publications by authors named "Michael Carducci"

Introduction: Non-castrating therapies are an unmet clinical need for patients with advanced prostate cancer. To maximize quality of life and prioritize cardiovascular health, we investigated SGLT2 inhibitors as a non-castrating therapy in patients with prostate cancer.

Materials And Methods: We conducted a retrospective analysis of patients with either local or biochemically recurrent prostate cancer who initiated therapy with an SGLT2 inhibitor without concurrent androgen deprivation therapy.

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Background And Objective: Owing to the expansion of treatment options for metastatic hormone-sensitive prostate cancer (mHSPC) and an appreciation of clinical subgroups with differential prognosis and treatment responses, prognostic and predictive biomarkers are needed to personalize care in this setting. Our aim was to evaluate a multimodal artificial intelligence (MMAI) biomarker for prognostic ability in mHSPC.

Methods: We used data from the phase 3 CHAARTED trial; 456/790 patients with mHSPC had evaluable digital histopathology images and requisite clinical variables to generate MMAI scores for inclusion in our analysis.

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Current US clinical practice guidelines for advanced prostate cancer management contain recommendations based on high-level evidence from randomized controlled trials; however, these guidelines do not address the nuanced clinical questions that are unanswered by prospective trials but nonetheless encountered in day-to-day practice. To address these practical questions, the 2024 US Prostate Cancer Conference (USPCC 2024) was created to generate US-focused expert clinical decision-making guidance for circumstances in which level 1 evidence is lacking. At the second annual USPCC meeting (USPCC 2024), a multidisciplinary panel of experts convened to discuss ongoing clinical challenges related to 5 topic areas: biochemical recurrence; metastatic, castration-sensitive prostate cancer; poly [ADP-ribose] polymerase inhibitors; prostate-specific membrane antigen radioligand therapy; and metastatic, castration-resistant prostate cancer.

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The phase 3 VISION trial demonstrated that [Lu]Lu-PSMA-617 prolonged progression-free survival and overall survival (OS) in prostate-specific membrane antigen [PSMA]-positive metastatic castration-resistant prostate cancer (mCRPC) patients who progressed on taxane-based chemotherapy and androgen receptor-signaling inhibitors (ARSIs). The U.S.

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[Lu]Lu-PSMA-617 was approved by the U.S. Food and Drug Administration for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).

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Importance: Olaparib is a poly(adenosine diphosphate-ribose) polymerase inhibitor that provides benefit in combination with hormonal therapies in patients with metastatic prostate cancer who harbor homologous recombination repair (HRR) alterations. Its efficacy in the absence of androgen deprivation therapy has not been tested.

Objective: To determine the activity of olaparib monotherapy among patients with high-risk biochemically recurrent (BCR) prostate cancer after radical prostatectomy.

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Article Synopsis
  • High-dose intravenous vitamin C (HDIVC) was tested alongside docetaxel in a clinical trial for patients with advanced prostate cancer, showing no significant benefit compared to docetaxel alone.
  • The trial involved 47 participants and measured effectiveness through PSA response rates, overall survival, and quality of life, with similar outcomes in both the HDIVC and placebo groups.
  • The study was halted early due to no evidence that HDIVC improved cancer treatment results, suggesting it shouldn’t be routinely used for metastatic castration-resistant prostate cancer.
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  • The study investigated the effectiveness of nivolumab, an immunotherapy drug, used before and after surgery in patients with high-risk renal cell carcinoma compared to traditional surgery alone.
  • It was a randomized phase 3 trial involving 819 patients across multiple sites in the US and Canada, who were assigned to either the nivolumab plus surgery group or surgery only group.
  • The primary outcome measured was recurrence-free survival, with safety being assessed for all patients who started treatment, and the trial has been officially closed to new participants.
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Background: Clinical trials examining lifestyle interventions for weight loss in cancer survivors have been demonstrated to be safe, feasible, and effective. However, scalable weight loss programs are needed to support their widespread implementation. The ASPIRE trial was designed to evaluate real-world, lifestyle-based, weight loss programs for cancer survivors throughout Maryland.

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Background: Management strategies for metastatic castration-resistant prostate cancer (mCRPC) have rapidly shifted in recent years. As novel imaging and therapeutic approaches have made their way to the clinic, providers are encountering increasingly challenging clinical scenarios, with limited guidance from the current literature.

Materials And Methods: The US Prostate Cancer Conference (USPCC) is a multidisciplinary meeting of prostate cancer experts intended to address the many challenges of prostate cancer management.

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Purpose: Castration-sensitive prostate cancer (CSPC) is a complex and heterogeneous condition encompassing a range of clinical presentations. As new approaches have expanded management options, clinicians are left with myriad questions and controversies regarding the optimal individualized management of CSPC.

Materials And Methods: The US Prostate Cancer Conference (USPCC) multidisciplinary panel was assembled to address the challenges of prostate cancer management.

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Background: Chemohormonal therapy with androgen deprivation therapy and docetaxel (ADT + D) improves overall survival (OS) and quality of life (QOL) at 12 mo versus androgen deprivation therapy (ADT) alone in men with metastatic hormone-sensitive prostate cancer (mHSPC). However, the prognostic role of QOL is unknown in this population.

Objective: To study the relationship between QOL, disease characteristics, and OS in men with mHSPC.

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Article Synopsis
  • Lysine-specific demethylase 1 (LSD1) plays a key role in the progression of metastatic castration-resistant prostate cancer (mCRPC), particularly in its neuroendocrine form (NEPC), highlighting the need for effective LSD1 inhibitors like bomedemstat for treating these cancers.
  • Bomedemstat was evaluated using various scientific methods, showing it is an irreversible inhibitor of LSD1 with significantly higher specificity over monoamine oxidase enzymes, and it effectively reduces tumor growth in prostate cancer models.
  • The study found that bomedemstat accumulates well in tumors after oral administration and has an overall tolerable safety profile with manageable side effects, supporting its clinical
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  • - Patients who had no evidence of disease (NED) after surgery for metastatic renal cell carcinoma (mRCC) were studied to see if pazopanib, a cancer medication, could improve their disease-free survival (DFS) compared to a placebo.
  • - The trial included 129 patients, and after thorough analysis, it found no significant difference in 3-year DFS rates between the pazopanib group (27.4%) and placebo group (21.9%).
  • - Additionally, the overall survival rate was better for the placebo group (91.4%) compared to pazopanib (81.9%), raising concerns about the drug's effectiveness and quality of life for patients on it.
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The objective of this study was to discover clinical and pharmacogenetic factors associated with bevacizumab-related gastrointestinal hemorrhage in Cancer and Leukemia Group B (Alliance) 90401. Patients with metastatic castration-resistant prostate cancer received docetaxel and prednisone ± bevacizumab. Patients were genotyped using Illumina HumanHap610-Quad and assessed using cause-specific risk for association between single nucleotide polymorphisms (SNPs) and gastrointestinal hemorrhage.

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Among the known nuclear exportins, CRM1 is the most studied prototype. Dysregulation of CRM1 occurs in many cancers, hence, understanding the role of CRM1 in cancer can help in developing synergistic therapeutics. The study investigates how CRM1 affects prostate cancer growth and survival.

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Physical impairments following cancer treatment have been linked with the toxic effects of these treatments on muscle mass and strength, through their deleterious effects on skeletal muscle mitochondrial oxidative capacity. Accordingly, we designed the present study to explore relationships of skeletal muscle mitochondrial oxidative capacity with physical performance and perceived cancer-related psychosocial experiences of cancer survivors. We assessed skeletal muscle mitochondrial oxidative capacity using in vivo phosphorus-31 magnetic resonance spectroscopy (P MRS), measuring the postexercise phosphocreatine resynthesis time constant, τPCr, in 11 post-chemotherapy participants aged 34-70 years.

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Purpose: Despite major increases in the longevity of men with metastatic hormone-sensitive prostate cancer (mHSPC), most men still die of prostate cancer. Phase III trials assessing new therapies in mHSPC with overall survival (OS) as the primary end point will take approximately a decade to complete. We investigated whether radiographic progression-free survival (rPFS) and clinical PFS (cPFS) are valid surrogates for OS in men with mHSPC and could potentially be used to expedite future phase III clinical trials.

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Cyclic high-dose testosterone administration, known as bipolar androgen therapy (BAT), is a treatment strategy for patients with metastatic castration-resistant prostate cancer (mCRPC). Here, we report the results of a multicenter, single arm Phase 2 study (NCT03554317) enrolling 45 patients with heavily pretreated mCRPC who received BAT (testosterone cypionate, 400 mg intramuscularly every 28 days) with the addition of nivolumab (480 mg intravenously every 28 days) following three cycles of BAT monotherapy. The primary endpoint of a confirmed PSA response rate was met and estimated at 40% (N = 18/45, 95% CI: 25.

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Background And Objective: Neoadjuvant cisplatin-based chemotherapy prior to radical cystectomy (RC) improves overall survival (OS) in muscle-invasive bladder cancer (MIBC). However, many patients are cisplatin ineligible; therefore, new treatment options are needed. Nivolumab without/with lirilumab prior to RC was investigated in cisplatin-ineligible patients in this phase 1b trial (NCT03532451) to determine its safety/feasibility.

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Purpose: Novel approaches are needed to ensure all patients with cancer have access to quality genetic education before genetic testing to enable informed treatment decisions. The purpose of this study was to test the use of an artificial intelligence (AI) intervention for the delivery of genetic education by non-genetic providers to patients with cancer undergoing active treatment.

Methods: A conversational AI-based application was developed on the HealthFAX platform to provide tailored genetic education to patients with cancer and tested at Johns Hopkins Hospital between April 2021 and Feb 2022.

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This study aims to examine the feasibility of DNA methylation age as a biomarker for symptoms and resilience in cancer survivors with multiple chronic conditions (MCCs). We included ten participants from our parent study, an ongoing randomized control trial study. Participants' symptoms and resilience were assessed, and peripheral blood was collected.

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