A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 4% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-10-25, after 2020-08-19 start.
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 2023-10-25. 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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Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 9.3% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancerthe purposepurpose ofbiopsytherapy
Phrases that lowered it: participantsprostatepsalabelandrogen -
Disease area, cancer: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 44.8% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 8.9% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 87 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 439 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Number of arms: 1 (raises risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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Drug's FAERS reports before start: 2000 (raises risk) · Drug's FDA history
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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 439 (typical: 32)
- Sponsor's past termination rate
- 9.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 87 (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
- 2000 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1145 (typical: 412.5)
- Drug's FAERS reports marked serious
- 44.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, urogenital
- Drugs matched to FDA substances
- apalutamide, relugolix
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
- A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR) NCT03311555 · started 2018 · scored riskier than 99% of active trials completed
- Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer NCT03124433 · started 2017 · scored riskier than 58% of active trials completed
- Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer NCT02789878 · started 2019 · scored riskier than 73% of active trials completed
- Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM) NCT02057939 · started 2014 · scored riskier than 99% of active trials completed
- Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy NCT00937768 · started 2009 · scored riskier than 69% 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.