Investigation of Metformin in Patients With Castration Resistant Prostate Cancer in Combination With Enzalutamide vs. Enzalutamide Alone
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-03-16, after 2016-06-10 start.
Reason given by the sponsor: “other”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2023-03-16. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancerhearttherapyconcurrentadenocarcinoma
Phrases that lowered it: patientspainopen labelthe trialmmhg -
Sponsor's past termination rate: 1.9% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 9.7% (lowers risk) · Drug's FDA history
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports before start: 170035 (lowers risk) · Drug's FDA history
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Sponsor's past trials: 53 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 63.2% (lowers risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 11 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Drug's FAERS reports in the prior 12 months: 41591 (lowers risk) · Drug's FDA history
-
Number of arms: 2 (raises risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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Maximum age: not given (raises risk) · Who can join
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
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 8 (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
- academic or other
- Sponsor's past trials
- 53 (typical: 32)
- Sponsor's past termination rate
- 1.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 170035 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 41591 (typical: 412.5)
- Drug's FAERS reports marked serious
- 63.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, urogenital
- Drugs matched to FDA substances
- enzalutamide, metformin
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
- Impact of the Addition of Metformin to Abiraterone in Metastatic Prostate Cancer Patients NCT01677897 · started 2013 · scored riskier than 33% of active trials completed
- Metformin Hydrochloride as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Prostate Cancer NCT01243385 · started 2010 · scored riskier than 83% of active trials completed
- Combination Study of AZD5069 and Enzalutamide. NCT03177187 · started 2017 · scored riskier than 37% of active trials terminated
- Enzalutamide and Metformin Hydrochloride in Treating Patients With Hormone-Resistant Prostate Cancer NCT02339168 · started 2016 · scored riskier than 30% of active trials completed
- Abiraterone Acetate in Combination With Tildrakizumab NCT04458311 · started 2020 · scored riskier than 23% of active trials terminated
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.