A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2017-11-08, after 2011-03-22 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2017-11-08. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 5.8% (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: cancerpriorto randomizationreceptorsubjects with
Phrases that lowered it: prostatepsaand safetyefficacy andcastration -
Trials the sponsor started in the prior 2 years: 121 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 26.0% (raises risk) · Drug's FDA history
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Sponsor's past trials: 275 (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Design: parallel (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Keywords listed: 6 (lowers risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Collaborators: 1 (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- male (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 275 (typical: 32)
- Sponsor's past termination rate
- 5.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 121 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 2671 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 518 (typical: 412.5)
- Drug's FAERS reports marked serious
- 88.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 26.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, urogenital
- Drugs matched to FDA substances
- bicalutamide, enzalutamide
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer NCT01664923 · started 2012 · scored riskier than 60% of active trials completed
- LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Hormone Sensitive Prostate Cancer NCT02058706 · started 2014 · scored riskier than 99% of active trials completed
- Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy NCT02203695 · started 2015 · scored riskier than 95% of active trials completed
- Trial of Abiraterone Acetate Plus LHRH-therapy Versus Abiraterone Acetate Sparing LHRH-therapy in Patients With Progressive Chemotherapy-naïve Castration-resistant Prostate Cancer (SPARE) NCT02077634 · started 2014 · scored riskier than 90% of active trials completed
- A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study. NCT05059236 · started 2021 · scored riskier than 54% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.