MP34-17 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER: POST HOC ANALYSIS OF PROSPER BY PROSTATE SPECIFIC-ANTIGEN PROGRESSION
Bibliographic record
Abstract
You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) IV (MP34)1 Apr 2019MP34-17 A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER: POST HOC ANALYSIS OF PROSPER BY PROSTATE SPECIFIC-ANTIGEN PROGRESSION Fred Saad*, Cora N. Sternberg, Eleni Efstathiou, Karim Fizazi, Katharina Modelska, Xiaowei Guan, Jennifer Sugg, Joyce Steinberg, and Bettina Noerby Fred Saad*Fred Saad* More articles by this author , Cora N. SternbergCora N. Sternberg More articles by this author , Eleni EfstathiouEleni Efstathiou More articles by this author , Karim FizaziKarim Fizazi More articles by this author , Katharina ModelskaKatharina Modelska More articles by this author , Xiaowei GuanXiaowei Guan More articles by this author , Jennifer SuggJennifer Sugg More articles by this author , Joyce SteinbergJoyce Steinberg More articles by this author , and Bettina NoerbyBettina Noerby More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555909.47437.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Nonrising prostate-specific antigen (PSA) at radiographic progression may occur in patients with metastatic castration-resistant prostate cancer (CRPC) treated with enzalutamide. In the primary analysis of PROSPER, enzalutamide provided a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) in patients with nonmetastatic (nm) CRPC. Here we report results in patients with or without PSA progression, defined according to PCWG2, at the time of metastasis or death. METHODS: Eligible patients with nmCRPC on bone and computed tomography scan, PSA doubling time ≤ 10 months, and PSA ≥ 2 ng/mL at screening continued androgen deprivation therapy and were randomized 2:1 to enzalutamide 160 mg or placebo. The primary endpoint was MFS. RESULTS: 1,401 patients were enrolled, with a median age of 74 years (range, 50-95 years). In all patients, enzalutamide reduced the risk of metastasis or death by 71% (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.24-0.35; P < .0001). Overall, 869 patients (62%) did not have PSA progression at the data cutoff date of June 28, 2017 (n/N = 725/933 [78%] in the enzalutamide group; n/N = 144/468 [31%] in the placebo group). Enzalutamide significantly reduced the risk of metastasis or death regardless of whether patients had PSA progression (HR with PSA progression, 0.57; 95% CI, 0.45-0.73; HR without PSA progression, 0.19; 95% CI, 0.13-0.29) (Table). CONCLUSIONS: In patients with nmCRPC and rapidly rising PSA, enzalutamide treatment resulted in a clinically meaningful and statistically significant reduction in the risk of developing metastases or death regardless of whether patients had PSA progression. The treatment effect was even greater in patients who did not have PSA progression. This finding requires further evaluation. Clinical trial identification: NCT02003924 Source of Funding: Pfizer Inc. and Astellas Pharma, Inc. Montreal, Canada; New York, NY; Houston, TX; Villejuif, France; San Francisco, CA; Northbrook, IL; Vejle, Denmark© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e502-e502 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Fred Saad* More articles by this author Cora N. Sternberg More articles by this author Eleni Efstathiou More articles by this author Karim Fizazi More articles by this author Katharina Modelska More articles by this author Xiaowei Guan More articles by this author Jennifer Sugg More articles by this author Joyce Steinberg More articles by this author Bettina Noerby More articles by this author Expand All Advertisement PDF downloadLoading ...
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.010 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".