RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)
Model scores of the 29,894 trials active now.
Model score 28% for any early termination, 13% 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 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 2021-11-11, after 2014-08-25 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 2021-11-11. 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: cancerpatients mustpatientmetastaticprostate
Phrases that lowered it: paintreatment withopioid30bipolar -
Sponsor's past termination rate: 35.6% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 56 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 18.2% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 71.7% (lowers risk) · Drug's FDA history
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Keywords listed: 5 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 4 (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Blinding: none (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Responsible party: sponsor (lowers 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
- 4 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (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
- 146 (typical: 32)
- Sponsor's past termination rate
- 35.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 56 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 12395 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5504 (typical: 412.5)
- Drug's FAERS reports marked serious
- 71.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, urogenital
- Drugs matched to FDA substances
- abiraterone, enzalutamide, testosterone, testosterone cypionate, testosterone enanthate
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
- Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance NCT02286921 · started 2015 · scored riskier than 76% of active trials completed
- Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer NCT05081193 · started 2022 · scored riskier than 83% of active trials completed
- A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer NCT01637402 · started 2013 · scored riskier than 67% of active trials completed
- Biomarker Analysis of Castration-resistant Prostate Cancer Undergoing Bipolar Androgen Therapy NCT04424654 · started 2020 · scored riskier than 74% of active trials completed
- Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC NCT04060394 · started 2019 · scored riskier than 41% 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.