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Prostate Cancer

FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancer

On September 17, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for patients with metastatic castration-sensitive prostate cancer. Apalutamide was initially approved by the FDA in 2018 for patients with nonmetastatic castration-resistant prostate cancer. TITAN Trial...

Prostate Cancer

ASTRO 2019: Long-Term Hormone Therapy May Increase Other-Cause Mortality in Men With Prostate Cancer Receiving Early Salvage Radiotherapy

Findings from the randomized phase III NRG Oncology/RTOG 9601 trial were initially reported in 2017, and showed that the addition of 2 years of antiandrogen therapy to postsurgical radiation treatment for men with recurrent prostate cancer increased their long-term overall survival rate. That study ...

Prostate Cancer

ASTRO 2019: ORIOLE Trial: Observation vs SABR for Oligometastatic Prostate Cancer

The randomized, phase II ORIOLE trial studying the efficacy of targeted high-dose radiation for men with oligometastatic prostate cancer has shown that stereotactic ablative radiation (SABR) is an effective and safe option for patients who wish to delay hormone-suppression therapy. Data from the...

Prostate Cancer

TITAN Trial: Apalutamide Adds to Options for Men With Metastatic Hormone-Sensitive Prostate Cancer

Androgen-deprivation therapy has been, and remains, the standard of care for patients with metastatic prostate cancer. Patients are often surprised to know that was all we would do to control their disease and sometimes asked why they would not get chemotherapy, as for other cancers. I would take...

Prostate Cancer

Addition of Apalutamide to Androgen-Deprivation Therapy in Metastatic Castration-Sensitive Prostate Cancer

As reported in The New England Journal of Medicine by Kim N. Chi, MD, of BC Cancer and Vancouver Prostate Centre, and colleagues, the first analysis of the phase III TITAN trial has shown that the addition of apalutamide to androgen-deprivation therapy improved radiographic progression-free and...

Prostate Cancer

Many Choices Now for Men With Metastatic Hormone-Sensitive Prostate Cancer: How to Decide?

Based on the recently published ENZAMET, ARCHES, and TITAN trials,1-3 we now have several choices of systemic combination therapies for men with metastatic hormone-sensitive prostate cancer; the ENZAMET trial is reviewed in this issue of The ASCO Post. In 2019, men are now faced with decisions of...

Prostate Cancer

Enzalutamide Improves Survival vs Standard First-Line Treatment in Hormone-Sensitive Metastatic Prostate Cancer

As reported in TheNew England Journal of Medicine by Ian D. Davis, MBBS, PhD, FRACP, FAChPM, of Monash University and Eastern Health in Melbourne, and colleagues, the phase III ENZAMET trial has shown that the androgen receptor inhibitor enzalutamide improved progression-free and overall survival...

Kidney Cancer
Prostate Cancer
Immunotherapy

Novel Treatments Under Study in Renal Cell Carcinoma and Prostate Cancer

There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...

Prostate Cancer

Looking at Prostate Cancer–Specific Mortality by Gleason Score and Race

Black men suffer disproportionately from prostate cancer, both in terms of incidence and mortality, compared with their white counterparts. However, a newer study conducted by investigators at the University of California, San Francisco, and Dana-Farber Cancer Institute, Boston, found that black...

Prostate Cancer

Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer

On July 30, 2019, darolutamide was approved for the treatment of patients with nonmetastatic castration-resistant prostate cancer.1,2 Approval was based on findings in the double-blind phase III ARAMIS trial (ClinicalTrials.gov identifier NCT02200614), in which 1,509 patients were randomly assigned ...

Kidney Cancer
Prostate Cancer
Immunotherapy

Novel Treatments Under Study in Renal Cell Carcinoma and Prostate Cancer

There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...

Prostate Cancer

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 nonmetastatic ...

lymphoma
prostate cancer

FDA 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 ...

prostate cancer

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 ...

leukemia
prostate cancer
gastrointestinal cancer

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...

prostate cancer

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...

prostate cancer

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...

prostate cancer

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 ...

prostate cancer
issues in oncology

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 ...

prostate cancer

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...

prostate cancer

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...

prostate cancer

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...

Prostate Cancer

Study Highlights on Novel Agents and Supportive Care Strategies in Prostate Cancer

In addition to our regular coverage of major news stories from the 2019 ASCO Annual Meeting, here is an additional roundup of important studies related to prostate cancer. ARAMIS: Darolutamide and Quality of Life Darolutamide, a next-generation androgen receptor antagonist, significantly prolonged...

Prostate Cancer

Active Surveillance for Early-Stage Prostate Cancer Requires Active Participation by Patient and Clinician

Active surveillance of patients with early-stage prostate cancer “is tackling the problem of overtreatment” and, with rigorous monitoring, “is safe and allows us to treat only patients who need treatment when their cancer progresses,” Ronald C. Chen, MD, MPH, affirmed in an interview with The ASCO...

prostate cancer
issues in oncology

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...

prostate cancer

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 ...

prostate cancer

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...

prostate cancer
survivorship

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 ...

prostate cancer

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...

Prostate Cancer

Two Studies Question the Role of Continuous LHRH Antagonists in Metastatic Castration‑Resistant Prostate Cancer

In the field of prostate cancer, the use of androgen-deprivation therapy (ADT) in men with metastatic castration-resistant prostate cancer is received wisdom. When experts are asked why ADT is continued once the disease has figured out how to evade hormone suppression, the answer invariably is...

Prostate Cancer

Apalutamide Improves Survival Outcomes in Castration-Sensitive Metastatic Prostate Cancer in TITAN Trial

Adding apalutamide to androgen-deprivation therapy (ADT) significantly improved survival in men with metastatic castration-sensitive (also termed hormone-sensitive) prostate cancer, according to the results of the phase III TITAN trial, which were presented at the 2019 ASCO Annual Meeting and...

Prostate Cancer

Chemotherapy and/or Hormonal Agents: Differing Perspectives

WHEN ASKED which treatment to start with—docetaxel or enzalutamide, Dr. Sweeney said, “Patients fit for chemotherapy with high-volume disease can receive chemotherapy [docetaxel] and come back to these newer hormonal treatments or start with anyone of the hormonal options. Choosing among the newer...

Prostate Cancer

ENZAMET Trial Shows Enzalutamide Improves Overall Survival in Hormone-Sensitive Metastatic Prostate Cancer

Agents that improve survival in metastatic castration-resistant prostate cancer when added to background androgen-deprivation therapy (ADT) are showing success in treating metastatic prostate cancer earlier while it is still hormone-sensitive. These agents include docetaxel (chemotherapy) and...

Prostate Cancer

Darolutamide in Nonmetastatic Castration-Resistant Prostate Cancer: Delaying Overt Metastatic Disease Is a Major Advance

Nonmetastatic (M0) castration-resistant prostate cancer arises in the subset of men with biochemically recurrent disease (ie, rising prostate-specific antigen [PSA] level after definitive therapy in the absence of metastases) who develop PSA progression after chronic exposure to...

Prostate Cancer

ARAMIS Trial: Darolutamide in Nonmetastatic Castration-Resistant Prostate Cancer

In a phase III ARAMIS trial reported in The New England Journal of Medicine, Karim Fizazi, MD, of the Institut Gustave Roussy, Universite Paris-Sud, Villejuif, France, and colleagues found that the androgen-receptor antagonist darolutamide significantly prolonged metastasis-free survival vs placebo ...

prostate cancer
issues in oncology

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...

prostate cancer

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 ...

prostate cancer

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)...

bladder cancer
kidney cancer
prostate cancer
solid tumors

Christopher Sweeney, MBBS, and Ian D. Davis, MBBS, PhD, on ANZUP: Taking a Multidisciplinary Approach to Prostate, Kidney, Bladder, Testicular, and Penile Cancers

Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, and Ian D. Davis, MBBS, PhD, of Monash University and Eastern Health, discuss the Australian and New Zealand Urogenital and Prostate Cancer Trials Group, working globally to speed clinical research in and treatment of urogenital cancers.

prostate cancer

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...

prostate cancer

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...

lymphoma
multiple myeloma
prostate cancer
immunotherapy

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...

prostate cancer

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 ...

prostate cancer

Kim N. Chi, MD, on Metastatic Castration-Sensitive Prostate Cancer: First Results From the TITAN Trial

Kim N. Chi, MD, of BC Cancer, discusses the first phase III findings from the TITAN study of apalutamide vs placebo in patients with metastatic castration-sensitive prostate cancer receiving androgen-deprivation therapy (Abstract 5006).

prostate cancer

Kim N. Chi, MD, on Castration-Resistant Prostate Cancer: Cabazitaxel vs Abiraterone or Enzalutamide in the Metastatic Setting

Kim N. Chi, MD, of BC Cancer, discusses updated results from a phase II study of cabazitaxel vs abiraterone or enzalutamide in patients with poor-prognosis metastatic castration-resistant prostate cancer (Abstract 5003).

prostate cancer

Michael J. Morris, MD, on Metastatic Prostate Cancer: Adding Abiraterone Acetate to Enzalutamide

Michael J. Morris, MD, of Memorial Sloan Kettering Cancer Center, discusses the phase III findings from the Alliance A031201 trial, which showed that adding abiraterone acetate to enzalutamide did not improve survival in men with metastatic castration-resistant prostate cancer (Abstract 5008).

prostate cancer

Miriam Knoll, MD, and Zachery Reichert, MD, PhD, on Prostate Cancer: Focal Radiation for Oligometastatic Castration-Resistant Disease

Miriam Knoll, MD, and Zachery Reichert, MD, PhD, discuss the FORCE trial, which is examining whether radiation can create a more durable response to systemic therapy, and whether using newer, more sensitive imaging technologies can improve outcomes (Abstract TPS5096).

prostate cancer

Karim Fizazi, MD, PhD, on the ARAMIS Trial in Prostate Cancer: Impact of Darolutamide on Pain and Quality of Life

Karim Fizazi, MD, PhD, of the Institut Gustave Roussy, University of Paris-Sud, discusses study findings showing that not only does darolutamide prolong metastasis-free survival, it maintains quality of life as well as delays worsening of pain and disease-related symptoms compared with placebo for patients with nonmetastatic castrate-resistant prostate cancer (Abstract 5000).

prostate cancer

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 ...

prostate cancer

Ian D. Davis, MBBS, PhD, and Christopher Sweeney, MBBS, on Prostate Cancer: ENZAMET Trial on Enzalutamide for Metastatic Hormone-Sensitive Disease

Ian D. Davis, MBBS, PhD, of Monash University and Eastern Health, and Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, discuss phase III findings from their international trial on adding enzalutamide as a new treatment option with testosterone suppression for metastatic hormone-sensitive prostate cancer (Abstract LBA2).

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