GuidelineJournal of clinical oncology : official journal of the American Society of Clinical Oncology2008
Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group.
Guideline in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 12 registered trials, which are not on this map. Cited by 1,080 papers, 8 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II, Open-Label, Single-Arm Study Evaluating the Safety, Efficacy and Pharmacokinetics of KX2-391 in Patients With Bone-Metastatic, Castration-Resistant Prostate Cancer Who Have Not Had Prior Chemotherapy
A Randomized Phase II Study of OGX-427 (a Second-Generation Antisense Oligonucleotide to Heat Shock Protein-27) in Patients With Castration Resistant Prostate Cancer Who Have Not Previously Received Chemotherapy for Metastatic Disease
A Pilot Study of F-18 Sodium Fluoride PET/CT for Metastatic Burden Qualification in Prostate Cancer
A Phase I and Randomized Phase II Multicenter Study of Cabozantinib (XL184) Plus Docetaxel and Prednisone in Metastatic Castrate Resistant Prostate Cancer
A Phase I/II Study of Alisertib in Combination With Abiraterone and Prednisone for Patients With Castration-Resistant Prostate Cancer After Progression on Abiraterone
F-choline PET in Early Response Assessment for Castration Resistant Prostatic Cancer Treated by Abiraterone Acetate or Enzalutamide
Utility of Exosomal microRNAs to Predict Response to Androgen Deprivation Therapy in Prostate Cancer Patients
A Phase I Trial of Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer (CRPC)
A Phase I Study of Entinostat in Combination With Enzalutamide for Treatment of Patients With Castration-Resistant Prostate Cancer
A Multicenter, Open-Label, Exploratory Platform Study to Evaluate Biomarkers and Immunotherapy Combinations for the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer
CHIO3 Trial: CHemotherapy Combined With Immune Checkpoint Inhibitor for Operable Stage IIIA/B Non-Small Cell Lung Cancer
A Phase II Single Arm, Multi-centre Trial of Triamcinolone With a GnRH Analog for Castration Resistant Prostate Cancer
Who cites it
1,080 citing papers in PubMed, 8 syntheses or guidelines pooled it, 2,225 citations in OpenAlex.
- Guideline of guidelines: lutetium-177 PSMA radioligand therapy in advanced prostate cancer.BJU international · 2026Guideline
- Efficacy and safety of triple or dual therapies for metastatic hormone-sensitive prostate cancer: a systematic review and Bayesian network meta-analysis.Future oncology (London, England) · 2026Pooled it
- Recommendations from the Galician Oncological Society and the Galician Society of Nuclear Medicine for the use ofClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Guideline
- Stereotactic body radiotherapy as metastasis-directed therapy in oligometastatic prostate cancer: a systematic review and meta-analysis of randomized controlled trials.Radiation oncology (London, England) · 2024Pooled it
- Prognostic significance of pretreatment systemic immune-inflammation index in patients with prostate cancer: a meta-analysis.World journal of surgical oncology · 2023Pooled it
- Efficacy and safety of olaparib combined with abiraterone in patients with metastatic castration-resistant prostate cancer: a systematic review and meta-analysis of randomized controlled trials.Frontiers in oncology · 2023Pooled it
- Comparative efficacy of second-generation androgen receptor inhibitors for treating prostate cancer: A systematic review and network meta-analysis.Frontiers in endocrinology · 2023Pooled it
- Statin and metformin use and outcomes in patients with castration-resistant prostate cancer treated with enzalutamide: A meta-analysis of AFFIRM, PREVAIL and PROSPER.European journal of cancer (Oxford, England : 1990) · 2022Pooled it
- AI-Based Pathology Classifier Predicts Sensitivity to Enzalutamide in Metastatic Hormone-Sensitive Prostate Cancer: A Biomarker Analysis of the ENZAMET Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Disease progression patterns and association of prostate-specific antigen level with risk of progression in nonmetastatic castration-resistant prostate cancer.Prostate cancer and prostatic diseases · 2026Trial
- Impact of Cardio-cerebrovascular Diseases on Enzalutamide and Abiraterone Treatment in Castration-resistant Prostate Cancer.JMA journal · 2026Trial
- A Phase II Study of Berzosertib in Combination with Carboplatin Compared with Docetaxel with Carboplatin in Metastatic Castration-Resistant Prostate Cancer.Cancer research communications · 2026Trial
- The Lowest PSA Level Achieved Before CRPC Predicts Abiraterone Response But Not Enzalutamide Response in Metastatic CRPC.The Prostate · 2026Trial
- Sequential Enzalutamide-Docetaxel Versus Abiraterone-Docetaxel Therapy in Castration-Resistant Prostate Cancer: A Subanalysis of the ENABLE Study.International journal of urology : official journal of the Japanese Urological Association · 2026Trial
- Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Trial
- Automated Imaging as an Adjunct to Serum and Clinical Biomarkers: A New Validated Prediction Tool for Metastatic Castration-Resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Effects of Prior Local Therapy by Radical Prostatectomy or Radiotherapy on the Efficacy and Quality of Life of Patients Treated With Darolutamide in ARAMIS.Cancer medicine · 2026Trial
- Chromosomal instability in circulating tumor cells and cabazitaxel resistance in metastatic castration-resistant prostate cancer.JCI insight · 2025Trial
- Continuous Androgen Deprivation Therapy with or Without Metastasis-directed Therapy for Oligometastatic Prostate Cancer: The Multicenter Phase 2 Randomized EXTEND Trial.European urology · 2025Trial
- Trial
1,020 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
21 authors at 1 institution in 1 country.
Funding
Abstract
purposeTo update eligibility and outcome measures in trials that evaluate systemic treatment for patients with progressive prostate cancer and castrate levels of testosterone.
methodsA committee of investigators experienced in conducting trials for prostate cancer defined new consensus criteria by reviewing previous criteria, Response Evaluation Criteria in Solid Tumors (RECIST), and emerging trial data.
resultsThe Prostate Cancer Clinical Trials Working Group (PCWG2) recommends a two-objective paradigm: (1) controlling, relieving, or eliminating disease manifestations that are present when treatment is initiated and (2) preventing or delaying disease manifestations expected to occur. Prostate cancers progressing despite castrate levels of testosterone are considered castration resistant and not hormone refractory. Eligibility is defined using standard disease assessments to authenticate disease progression, prior treatment, distinct clinical subtypes, and predictive models. Outcomes are reported independently for prostate-specific antigen (PSA), imaging, and clinical measures, avoiding grouped categorizations such as complete or partial response. In most trials, early changes in PSA and/or pain are not acted on without other evidence of disease progression, and treatment should be continued for at least 12 weeks to ensure adequate drug exposure. Bone scans are reported as "new lesions" or "no new lesions," changes in soft-tissue disease assessed by RECIST, and pain using validated scales. Defining eligibility for prevent/delay end points requires attention to estimated event frequency and/or random assignment to a control group.
conclusionPCWG2 recommends increasing emphasis on time-to-event end points (ie, failure to progress) as decision aids in proceeding from phase II to phase III trials. Recommendations will evolve as data are generated on the utility of intermediate end points to predict clinical benefit.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.