Publications by authors named "Curtis Dunshee"
Background: This detailed analysis further characterizes the safety profile of talazoparib plus enzalutamide in the ongoing randomized, phase III TALAPRO-2 study in patients with metastatic castration-resistant prostate cancer (mCRPC). In both the all-comers and homologous recombination repair (HRR)-deficient populations, talazoparib plus enzalutamide significantly improved radiographic progression-free survival compared with placebo plus enzalutamide.
Methods: The talazoparib plus enzalutamide safety populations in TALAPRO-2 included 398 patients from cohort 1 (all-comers, unselected for HRR gene alterations) and 198 patients from the combined HRR-deficient population (patients from the all-comers population with HRR gene alterations plus subsequently enrolled patients with HRR gene alterations; cohort 2).
What Is This Summary About?: This summary describes the results from the TALAPRO-2 research study (also known as a clinical trial). The TALAPRO-2 study tested the combination of two medicines called talazoparib plus enzalutamide. This combination of medicines was used as the first treatment for adult patients with metastatic castration-resistant prostate cancer.
View Article and Find Full Text PDFIntroduction: Metastatic castration-resistant prostate cancer (mCRPC) remains incurable and develops from biochemically recurrent PC treated with androgen deprivation therapy (ADT) following definitive therapy for localized PC, or from metastatic castration-sensitive PC (mCSPC). In the mCSPC setting, treatment intensification of ADT plus androgen receptor (AR)-signaling inhibitors (ARSIs), with or without chemotherapy, improves outcomes vs ADT alone. Despite multiple phase 3 trials demonstrating a survival benefit of treatment intensification in PC, there remains high use of ADT monotherapy in real-world clinical practice.
View Article and Find Full Text PDFArticle Synopsis
- Preclinical studies indicate a link between the androgen receptor and poly(ADP-ribose) polymerase in prostate cancer, suggesting that inhibiting both may effectively treat metastatic castration-resistant prostate cancer (mCRPC).
- The TALAPRO-2 phase 3 study compared the effects of combining talazoparib (a poly(ADP-ribose) polymerase inhibitor) with enzalutamide against enzalutamide alone, specifically focusing on patients with DNA damage response gene alterations.
- Results showed that the combination therapy significantly extended radiographic progression-free survival for patients with homologous recombination repair (HRR) deficiencies, with the talazoparib group not reaching median survival at the time of
Background: Co-inhibition of poly(ADP-ribose) polymerase (PARP) and androgen receptor activity might result in antitumour efficacy irrespective of alterations in DNA damage repair genes involved in homologous recombination repair (HRR). We aimed to compare the efficacy and safety of talazoparib (a PARP inhibitor) plus enzalutamide (an androgen receptor blocker) versus enzalutamide alone in patients with metastatic castration-resistant prostate cancer (mCRPC).
Methods: TALAPRO-2 is a randomised, double-blind, phase 3 trial of talazoparib plus enzalutamide versus placebo plus enzalutamide as first-line therapy in men (age ≥18 years [≥20 years in Japan]) with asymptomatic or mildly symptomatic mCRPC receiving ongoing androgen deprivation therapy.
Article Synopsis
- This study investigates the safety and tolerability of relugolix when combined with abiraterone acetate and apalutamide for treating prostate cancer.
- The ongoing trial involves men with different stages of prostate cancer and assesses various health indicators over 52 weeks, focusing on adverse events, vital signs, and hormone levels.
- Results show that the combination therapy is generally safe, with mild to moderate side effects consistent with known profiles, and testosterone levels remain at castration levels post-transition.
PARP inhibitors in combination with androgen receptor-targeted therapy have demonstrated potential in the treatment of metastatic castration-resistant prostate cancer (mCRPC). Here, we describe the design and rationale of the multinational, phase III, two-part TALAPRO-2 study comparing talazoparib plus enzalutamide versus placebo plus enzalutamide as a first-line treatment for patients with mCRPC with or without DNA damage response (DDR) alterations. This study has two co-primary end points: radiographic progression-free survival (rPFS) by blinded independent clinical review in all-comers (cohort 1) and in patients with DDR alterations (cohort 2).
View Article and Find Full Text PDFBackground: In the phase 2, randomized, double-blind STRIVE trial, enzalutamide significantly reduced the risk of prostate cancer progression or death versus bicalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) and nonmetastatic CRPC (nmCRPC). The objective of this protocol-specified subgroup analysis of STRIVE was to investigate the benefit of enzalutamide versus bicalutamide specifically in patients with nmCRPC.
Methods: Patients (N = 139) were stratified by disease stage and randomized to enzalutamide 160 mg/day plus androgen deprivation therapy (ADT; n = 70) or bicalutamide 50 mg/day plus ADT (n = 69).
Background: Advanced prostate cancer (PC) patients, especially those with metastatic prostate cancer (mPC), often require complex management pathways. Despite the publication of clinical practice guidelines by leading urological and oncological organizations that provide a substantial and comprehensive framework, there are numerous clinical scenarios that are not always addressed, especially as new treatments become available, new imaging modalities are developed, and advances in genetic testing continue.
Methods: A 14-member expert review panel comprised of urologists and medical oncologists were chosen to provide guidance on addressing specific topics and issues regarding metastatic castration-resistant prostate cancer (mCRPC) patients.
Background: In the ARCHES study in metastatic hormone-sensitive prostate cancer (mHSPC), enzalutamide plus androgen deprivation therapy (ADT) improved radiographic progression-free survival (rPFS) versus ADT alone.
Objective: To evaluate patient-reported outcomes (PROs) to week 73.
Design, Setting, And Participants: ARCHES (NCT02677896) was a randomised, double-blind, placebo-controlled, phase 3 study in mHSPC patients.
Article Synopsis
- Enzalutamide, an oral drug that inhibits androgen receptors, showed superior survival benefits for men with metastatic castration-resistant prostate cancer (CRPC) compared to bicalutamide in a clinical study.
- In a trial involving 396 men, those taking enzalutamide had a median progression-free survival (PFS) of 19.4 months, significantly longer than the 5.7 months seen with bicalutamide.
- Enzalutamide also outperformed bicalutamide in several secondary measures, demonstrating better outcomes for patients regardless of whether their cancer was metastatic or nonmetastatic.