PSA Flare With Abiraterone in Patients With Metastatic Castration-Resistant Prostate Cancer

Burgio, Salvatore Luca; Conteduca, Vincenza; Rudnas, Britt; Carrozza, Francesco; Campadelli, Enrico; Bianchi, Emanuela; Fabbri, Paolo; Montanari, Marco; Carretta, Elisa; Menna, Cecilia; Giorgi, Ugo De

doi:10.1016/j.clgc.2014.06.010

Cited by 63 publications

(53 citation statements)

References 23 publications

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“…PSA flares occurred in 7.6% to 13.8% of patients and four courses of docetaxel were, at least, recommended (25). In terms of AR-targeting agents, PSA flare has been reported in patients treated with abiraterone acetate (26), but in less than 10% percent, and did not affect prognosis. Since AR-targeting agents affect AR action by ligand depletion or interference with signal transduction, a transient rise in PSA would be expected to be rare.…”

Section: Discussionmentioning

confidence: 99%

Consequences of an Early PSA Response to Enzalutamide Treatment for Japanese Patients with Metastatic Castration-resistant Prostate Cancer

Kato

Furuya

Miyazawa

et al. 2016

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Section: Discussionmentioning

confidence: 99%

Consequences of an Early PSA Response to Enzalutamide Treatment for Japanese Patients with Metastatic Castration-resistant Prostate Cancer

Kato

Furuya

Miyazawa

et al. 2016

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“…PSA response rates have been utilized as an early readout of clinical benefit at interim/futility analysis of phase III clinical trials for novel investigational agents for treatment of patients with metastatic prostate cancer (37). It should be mentioned that early PSA flare/rise may occur in some patients after AA treatment (38). PCWG2 recommends evaluating PSA response after 12 weeks (29).…”

Section: Discussionmentioning

confidence: 99%

Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate–Treated Castration-Resistant Prostate Cancer Patients

Ryan

Stuyckens

et al. 2015

Clinical Cancer Research

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Purpose: We constructed a biomarker-survival modeling framework to explore the relationship between prostate-specific antigen (PSA) kinetics and overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC) patients following oral administration of 1,000 mg/day of abiraterone acetate (AA).Experimental Design: The PSA-survival modeling framework was based on data from two phase III studies, COU-AA-301 (chemotherapypretreated,n¼ 1,184)andCOU-AA-302(chemotherapy na€ ve, n ¼ 1,081), and included a mixed-effects tumor growth inhibition model and a Cox proportional hazards survival model.Results: The effect of AA on PSA kinetics was significant (P < 0.0001) and comparable between the chemotherapy-na€ ve and -pretreated patients. PSA kinetics [e.g., PSA nadir, PSA response rate (!30%, 50%, and 90%), time to PSA progression, PSA doubling time (PSADT)] were highly associated with OS in both populations. The model-based posttreatment PSADT had the strongest association with OS (HR $0.9 in both populations). The models could accurately predict survival outcomes. After adjusting for PSA kinetic endpoints, the treatment effect of AA on survival was no longer statistically significant in both studies, and the Prentice criteria of surrogacy were met for the PSA kinetic endpoints. A strong correlation was also observed between PSA and radiographic progression-free survival.Conclusions: The analysis revealed a consistent treatment effect of AA on PSA kinetics and strong associations between PSA kinetics and OS in chemotherapy-pretreated and -na€ ve patients, thereby providing a rationale to consider PSA kinetics as surrogacy endpoints to indicate clinical benefit in AA-treated patients with mCRPC regardless of chemotherapy treatment.

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“…PSA flare has been described following initiation of chemotherapy or newer hormonal therapies with significant PSA falls after initial rise [72][73][74].…”

Section: Annals Of Oncology Special Articlesmentioning

confidence: 99%

Management of patients with advanced prostate cancer: recommendations of the St Gallen Advanced Prostate Cancer Consensus Conference (APCCC) 2015

Gillessen¹,

Omlin²,

Attard³

et al. 2019

Annals of Oncology

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advanced prostate cancer (APC) management. The successful registration of several drugs for castration-resistant prostate cancer and the recent studies of chemo-hormonal therapy in men with castration-naïve prostate cancer have led to considerable uncertainty as to the best treatment choices, sequence of treatment options and appropriate patient selection. Management recommendations based on expert opinion, and not based on a critical review of the available evidence, are presented. The various recommendations carried differing degrees of support, as reflected in the wording of the article text and in the detailed voting results recorded in supplementary Material, available at Annals of Oncology online. Detailed decisions on treatment as always will involve consideration of disease extent and location, prior treatments, host factors, patient preferences as well as logistical and economic constraints. Inclusion of men with APC in clinical trials should be encouraged.

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PSA Flare With Abiraterone in Patients With Metastatic Castration-Resistant Prostate Cancer

Cited by 63 publications

References 23 publications

Consequences of an Early PSA Response to Enzalutamide Treatment for Japanese Patients with Metastatic Castration-resistant Prostate Cancer

Consequences of an Early PSA Response to Enzalutamide Treatment for Japanese Patients with Metastatic Castration-resistant Prostate Cancer

Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate–Treated Castration-Resistant Prostate Cancer Patients

Management of patients with advanced prostate cancer: recommendations of the St Gallen Advanced Prostate Cancer Consensus Conference (APCCC) 2015

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