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Showing 1 - 50FDA Pipeline: Priority Reviews in Prostate Cancer, Mantle Cell Lymphoma
This week, the U.S. Food and Drug Administration (FDA) accepted new drug applications for enzalutamide in metastatic hormone-sensitive prostate cancer and zanubrutinib in relapsed or refractory mantle cell lymphoma, and granted both applications Priority Review. Priority Review for Enzalutamide in ...
Mortality Risk for Patients With Preexisting Cardiovascular Conditions Treated With Abiraterone Acetate or Enzalutamide
A new population-based study showed that novel oral androgen signaling–inhibitor therapies may be associated with an increased risk of death in patients with preexisting cardiovascular conditions. The research was published by Lu-Yao et al in European Urology. “Data from published ...
FDA Pipeline: Designation in CLL, New Drug Application in GIST, New Prostate Ablation System Receives 510(k) Clearance
Recently, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to acalabrutinib in chronic lymphocytic leukemia (CLL), accepted a new drug application for avapritinib in some types of gastrointestinal stromal tumors (GIST), and granted 501(k) clearance to market the...
FDA Review Finds No Increased Risk of Prostate Cancer With Parkinson's Disease Treatments Containing Entacapone
A U.S. Food and Drug Administration (FDA) review of additional data found no increased risk of prostate cancer with the use of entacapone to treat Parkinson’s disease. The FDA conducted this review after an earlier trial—the Stalevo Reduction in Dyskinesia Evaluation–Parkinson's...
Are MRI-Assisted Biopsies More Effective Than Standard Ultrasound-Guided Biopsies Alone in the Detection of Prostate Cancer?
Using magnetic resonance imaging (MRI) to target biopsies is more effective at detecting prostate cancers that are likely to need treatment than standard ultrasound-guided biopsies alone, according to research published by Elwenspoek et al in JAMA Network Open. Prostate biopsies can cause side...
Comparison of Scans for Detection of Early Biochemical Recurrence of Prostate Cancer After Prostatectomy
In a single-center study reported in The Lancet Oncology, Calais et al found that the use of gallium Ga-68 prostate-specific membrane antigen-11 positron-emission tomography/computed tomography (PSMA PET/CT) resulted in higher detection rates of early biochemical recurrence of prostate cancer after ...
Androgen-Deprivation Therapy May Increase Risk for QT Prolongation and Torsades de Pointes
In a study published by Salem et al in Circulation, researchers examined how several testosterone-blocking drugs commonly used in the treatment of prostate cancer affect the heart's QT interval. The longer a QT interval—typically measured by an electrocardiogram—the more at risk a ...
Adjuvant Radiotherapy After Radical Prostatectomy vs Radical Prostatectomy Alone in Patients With Positive Margins or Extracapsular Extension
In patients with prostate cancer with surgical positive margins or extracapsular extension of their disease, the risk of disease recurrence postprostatectomy is higher than in cases where the cancer cells are confined within the prostate. The Finnish FinnProstataX study investigated...
FDA Approves Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer
On July 30, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa) for the treatment of nonmetastatic castration-resistant prostate cancer. Approval was based on the ARAMIS study, a multicenter, double-blind, placebo-controlled clinical trial of 1,509 patients with...
ARCHES: Enzalutamide Plus ADT in Metastatic Hormone-Sensitive Prostate Cancer
As reported in the Journal of Clinical Oncology by Armstrong et al, findings from the phase III ARCHES trial have shown significant improvement in radiographic progression-free survival with enzalutamide plus androgen-deprivation therapy (ADT) vs placebo plus ADT in men with metastatic...
Association Between ADT for Prostate Cancer and Diagnosis of Alzheimer Disease or Dementia in Older Patients
In a report published by Jayadevappa et al in JAMA Network Open, researchers found that among older patients with prostate cancer, treatment with androgen-deprivation therapy (ADT) was associated with a subsequent diagnosis of Alzheimer disease or dementia over a follow-up period of at least 10...
SNMMI 2019: Phase I/II Trial of Lutetium-177–PSMA-617 Plus Idronoxil in Metastatic Castration-Resistant Prostate Cancer
A novel therapy using two targeted treatments for prostate cancer has been shown to maximize efficacy while reducing side effects, according to research presented at the 2019 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) and published by Emmett et al in The Journal ...
SNMMI 2019: PSMA PET During Lu-177–PSMA Radioligand Therapy May Help Guide Treatment
Prostate-specific membrane antigen (PSMA) positron-emission tomography (PET) imaging of patients with metastatic castration-resistant prostate cancer after two cycles of lutetium-177 (Lu-177)-PSMA radioligand therapy has shown a significant predictive value for patient survival. The research was...
Evaluation of PROMIS Measures After Radical Prostatectomy
In a study reported in the Journal of Clinical Oncology, Agochukwu et al validated the sexual interest and sexual satisfaction single-item measures of the Patient-Reported Outcome Measurement Information System (PROMIS) in men who underwent radical prostatectomy for prostate cancer. The study ...
Failure-Free Survival With Ultrahypofractionated vs Conventionally Fractionated Radiotherapy in Prostate Cancer
In the Scandinavian phase III HYPO-RT-PC trial reported in The Lancet, Widmark et al found that ultrahypofractionated radiotherapy was noninferior to conventionally fractionated radiotherapy in failure-free survival in patients with intermediate- to high- risk prostate cancer. Study Details In...
Exposure to Specific Carcinogens and Prostate Cancer Risk Among World Trade Center First Responders
Since the attacks on the World Trade Center on September 11, 2001, studies have shown an increased risk of several cancers—including multiple myeloma and prostate, head and neck, and thyroid cancers—among first responders to the scene. The results from a new study by Gong et al...
Body Fat Distribution and Risk of Aggressive Prostate Cancer
In a prospective study of directly measured body fat distribution and prostate cancer risk, investigators found that higher levels of abdominal and thigh fat are associated with an increased risk of aggressive prostate cancer. The findings—published by Dickerman et al in Cancer—may lead ...
Toxicity With Prostate-Only vs Prostate and Pelvic Lymph Node Intensity-Modulated Radiation Therapy
In a UK national population-based study reported in the Journal of Clinical Oncology, Parry et al found virtually no difference in gastrointestinal or genitourinary toxicity associated with prostate-only (PO-IMRT) vs prostate and pelvic lymph node intensity-modulated radiation therapy (PPLN-IMRT)...
2019 ASCO: TOPARP-B Finds Olaparib Shows Efficacy in Men With BRCA-Mutant Prostate Cancer
The poly (ADP-ribose) polymerase (PARP) inhibitor olaparib may benefit some men with prostate cancer, according to findings from the phase II TOPARP-B trial presented by Mateo et al at the 2019 ASCO Annual Meeting (Abstract 5005). Olaparib previously showed activity against metastatic...
Cancer-Specific and Other-Cause Mortality Among Black Men With Prostate Cancer
In a study reported in JAMA Oncology, Dess et al found that after adjustment for nonbiologic differences, black men with nonmetastatic prostate cancer did not appear to have higher rates of prostate cancer–specific mortality vs white men. Black patients had higher rates of other-cause...
FDA Pipeline: Reviews and Designations in Multiple Myeloma, Lymphoma, Prostate Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review for daratumumab in combination with a triplet therapy in multiple myeloma, Breakthrough Therapy designation to copanlisib for marginal zone lymphoma, and Fast Track designation for ARV-110 in metastatic...
Active Surveillance/Watchful Waiting for Black Patients With Low-Risk Prostate Cancer
In a study reported in a letter to the editor in The New England Journal of Medicine, Butler et al found that the proportion of black patients with low-risk prostate cancer undergoing active surveillance remained lower than that among nonblack patients, despite increased use of the strategy in both ...
2019 ASCO: ENZAMET: Addition of Enzalutamide to Standard of Care in Metastatic Hormone-Sensitive Prostate Cancer
An interim analysis of the international, randomized phase III ENZAMET trial found that 80% of men with metastatic hormone-sensitive prostate cancer who received the nonsteroidal antiandrogen agent enzalutamide along with standard-of-care treatment were alive after 3 years, compared with 72% of men ...
2019 ASCO: TITAN Study Assesses Apalutamide vs Placebo During Androgen-Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer
Results from the phase III TITAN trial, presented by Chi et al at the 2019 ASCO Annual Meeting (Abstract 5006), showed that the addition of apalutamide to androgen-deprivation therapy (ADT) improved radiographic progression-free and overall survival in patients with metastatic castration-sensitive...
Prostate-Only vs Whole-Pelvis Radiotherapy in Gleason Grade 5 Prostate Cancer
In a retrospective analysis published in European Urology, Sandler et al examined the protocol for treating aggressive prostate cancer. Researchers aimed to study the impact of whole-pelvis radiation on men with Gleason grade 5 disease who had been treated with external-beam radiotherapy with...
Alterations in the RB1 Gene and Outcomes in Metastatic Castration-Resistant Prostate Cancer
Scientists have identified a genetic mutation in the tumors of some men with prostate cancer that is linked to very poor survival, and which could be used to help select certain patients for more intensive treatment. These findings were published by Abida et al in the Proceedings of the...
ASTRO and AUA Announce Updates to Joint Clinical Guidance for Adjuvant and Salvage Radiotherapy After Prostatectomy
The American Society for Radiation Oncology (ASTRO) and the American Urological Association (AUA) recently announced updates to their joint clinical guideline on adjuvant and salvage radiotherapy after prostatectomy in patients with and without evidence of prostate cancer recurrence to include new...
Alcohol Intake and Risk of Lethal Prostate Cancer
As reported by Downer et al in the Journal of Clinical Oncology, findings from the Health Professionals Follow-up Study indicate that moderate alcohol consumption is safe for patients with prostate cancer. Study Details The prospective cohort study used data from the Health Professionals...
AUA 2019: Insights in Prostate Cancer Identification and Management
Prostate cancer diagnosis and treatment are ever-changing, with new research showcasing different ways to identify and manage patients with the disease. Three new abstracts—highlighting how beta-blockers may impact prostate cancer risk, the advantages and disadvantages of using magnetic...
ESTRO 38: REQUITE Project Finds Predictive Biomarkers for Late Radiotherapy Toxicity
The latest results from the REQUITE project, which aimed to discover what makes patients more likely to experience adverse effects after radiotherapy, have shown that a combination of biologic markers and certain genetic changes can predict radiation sensitivity. In addition, the international team ...
ESTRO 38: High–Dose Rate Brachytherapy in Localized Prostate Cancer
A single high dose of radiation that can be delivered directly to a treatment site within a few minutes is a safe and effective technique for treating men with localized, low-risk prostate cancer, according to a study presented by Tharmalingam et al at ESTRO 38, the annual congress of the ...
FDA Pipeline: Applications and Designations in Prostate Cancer, Leukemia, and HER2-Positive Cancers
In the past 2 weeks, the U.S. Food and Drug Administration (FDA) accepted a new drug application and granted Priority Review for a prostate cancer treatment, granted Orphan Drug designation to a treatment for acute lymphoblastic leukemia, accepted an investigational new drug application for a...
Final Overall Survival Analysis of the LATITUDE Trial in Newly Diagnosed, High-Risk, Metastatic, Castration-Sensitive Prostate Cancer
As reported in The Lancet Oncology by Fizazi et al, the final overall survival analysis in the phase III LATITUDE trial has shown a significant benefit with the addition of abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) in newly diagnosed, high-risk, metastatic, ...
Risk of Subsequent Primary Cancers After Carbon Ion Radiotherapy for Localized Prostate Cancer
In a Japanese retrospective study reported in The Lancet Oncology, Mohamad et al found that carbon ion radiotherapy was associated with a lower risk of subsequent primary cancers compared with photon radiotherapy in patients with localized prostate cancer. The study included data on 1,455 patients ...
Addition of Docetaxel to Androgen Suppression and Radiotherapy for Localized High-Risk Prostate Cancer
As reported in the Journal of Clinical Oncology by Rosenthal et al, the phase III NRG Oncology RTOG 0521 trial showed that the addition of docetaxel to androgen suppression and radiotherapy improved overall and disease-free survival as well as the distant metastasis rate in patients with high-risk...
Focal Laser Ablation in Prostate Cancer
Researchers have shown that selectively destroying cancerous prostate tissue may be as effective as complete prostate removal or radiation therapy, while preserving more sexual and urinary function than these other treatments. The study was published by Wasler et al in the Journal of Vascular and...
AR-V7 Assay Findings and Outcomes With Hormone Therapy in High-Risk Castration-Resistant Prostate Cancer
In the PROPHECY study, reported in the Journal of Clinical Oncology, Armstrong et al found that positive findings on 2 assays for circulating tumor cell (CTC) androgen receptor splice variant 7 (AR-V7) were associated with poorer outcomes for abiraterone and enzalutamide therapy in men with...
EAU 2019: Testosterone Replacement Therapy May Slow Recurrence in Low-Risk Prostate Cancer
Researchers have shown that testosterone replacement may slow the recurrence of prostate cancer in low-risk patients. Findings from the study were presented by Towe et al at the European Association of Urology (EAU) 2019 Congress (Abstract 646). Practitioners have long regarded testosterone as a...
Viral Vector–Based Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
In a phase III trial reported in the Journal of Clinical Oncology, Gulley et al found that PROSTVAC, a viral vector-based immunotherapy, did not improve overall survival or 6-month event-free survival vs placebo in patients with asymptomatic or minimally symptomatic metastatic castration-resistant...
Intense Neoadjuvant Androgen Deprivation Before Prostatectomy in Locally Advanced Prostate Cancer
In a phase II trial reported in the Journal of Clinical Oncology, McKay et al found a trend toward improved pathologic response or minimal residual disease with the addition of neoadjuvant abiraterone and prednisone to enzalutamide and leuprolide prior to radical prostatectomy in patients with...
Prevalence of Adverse Germline Genetic Variants in Prostate Cancer
In a study reported in JAMA Oncology by Nicolosi et al, it was found that 17% of men with prostate cancer had likely deleterious germline genetic variants, and that many of these men would not have been considered candidates for genetic testing. Study Details The study involved data from 3,607...
AACR 2019: Does Treatment With Abiraterone Acetate Benefit Patients With Advanced Prostate Cancer and Preexisting Cardiovascular Disease?
Patients with advanced prostate cancer who had preexisting cardiovascular disease had a higher risk of mortality in the 6 months after starting abiraterone acetate treatment compared with those who had no preexisting cardiovascular disease, according to data presented by Lu-Yao et al at a presscast ...
Addition of Radium-223 to Abiraterone Acetate and Prednisone or Prednisolone in Metastatic Castration-Resistant Prostate Cancer
In the phase III ERA 223 trial reported in The Lancet Oncology, Smith et al found that the addition of radium-223 to abiraterone acetate and prednisone or prednisolone did not improve symptomatic skeletal event-free survival and was associated with increased risk of fracture in patients with...
Addition of Docetaxel to Hormone Therapy in High-Risk Prostate Cancer With Rising PSA Levels
In a French phase III trial reported in JAMA Oncology, Oudard et al found that the addition of docetaxel to androgen-deprivation therapy (ADT) did not improve prostate-specific antigen (PSA) progression-free survival in men with high-risk prostate cancer with rising PSA after primary local therapy. ...
Patient-Reported Outcomes With Enzalutamide in PROSPER Trial
As reported by Tombal et al in The Lancet Oncology, treatment with enzalutamide was associated with clinically meaningful delays in pain progression, symptom worsening, and deterioration in functional status vs placebo in the phase III PROSPER trial in nonmetastatic, castration-resistant prostate...
Hospitalizations in Patients With Prostate Cancer on Medicare
In a retrospective analysis reported in the Journal of Oncology Practice, Parikh et al found that more than one-quarter of hospitalizations in Medicare patients with prostate cancer were potentially avoidable. Study Details The study involved 99 evaluable patients in the Mount Sinai Health System ...
2019 GU Cancers Symposium: ARAMIS: Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer
In the phase III ARAMIS trial reported by Fizazi et al at the 2019 Genitourinary Cancers Symposium (Abstract 140) and simultaneously published in The New England Journal of Medicine, researchers found that the androgen receptor antagonist darolutamide significantly prolonged metastasis-free...
2019 GU Cancers Symposium: CheckMate 650: Nivolumab and Ipilimumab in Metastatic, Castration-Resistant Prostate Cancer
Some patients with metastatic prostate cancer respond to a combination of immune checkpoint inhibitors after treatment with hormonal therapy and chemotherapy has not been successful in treating their disease, according to early results from the phase II CheckMate 650...
2019 GU Cancers Symposium: Study Evaluates Survival by Race in Metastatic Castration-Resistant Prostate Cancer
A large, retrospective study analyzing 5 years of data from the Veterans Health Administration (VHA) found that African American men with chemotherapy-naive, metastatic, castration-resistant prostate cancer who were treated with abiraterone acetate or enzalutamide lived 20% longer compared with...
2019 GU Cancers Symposium: Small Trial of LuPSMA in PSMA-Positive, Metastatic, Castration-Resistant Prostate Cancer
A single-arm, phase II trial in men with prostate-specific membrane antigen (PSMA)-positive, metastatic, castration-resistant prostate cancer that progressed despite standard therapies found that a majority of men treated with a novel, targeted radiation therapy called lutetium-177 PSMA-617...
