Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

NCT01618370 on ClinicalTrials.gov Phase 3 Bayer (industry) Started 2012-07-22 Completed

Riskier than 18% of active trials

Model scores of the 29,894 trials active now.

Model score 11% 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 16% of the time (927 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 2016-02-28, after 2012-07-22 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 2016-02-28. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: bonecancermetastaticfailureimaging
Phrases that lowered it: psaprostatelungpatients whora
Phase: 3 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Drug's FAERS reports marked serious: 48.0% (lowers risk) · Drug's FDA history
Sponsor's past termination rate: 6.7% (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 3.1% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 103 (lowers risk) · Sponsor's track record
Sponsor's past trials: 446 (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Design: single group (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Responsible party: sponsor (lowers risk) · Design
Number of arms: 1 (raises risk) · Design
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: 3 (typical: 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: 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: 446 (typical: 32)
Sponsor's past termination rate: 6.7% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 103 (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: 98 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 42 (typical: 412.5)
Drug's FAERS reports marked serious: 48.0% (typical: 85.6%)
Drug's FAERS reports with a death: 3.1% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital
Drugs matched to FDA substances: radium

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

Radium-223 Dichloride Asian Population Study in the Treatment of CRPC Patients With Bone Metastasis NCT01810770 · started 2013 · scored riskier than 21% of active trials completed
Radium Ra 223 With Enzalutamide Compared to Enzalutamide Alone in Men With Metastatic Castration Refractory Prostate Cancer NCT02199197 · started 2014 · scored riskier than 91% of active trials completed
A Biomarker Study of Standard-of-care Radium-223 Chloride for Metastatic Castration-resistant Prostate Cancer NCT02346526 · started 2015 · scored riskier than 98% of active trials completed
Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer NCT02278055 · started 2014 · scored riskier than 49% of active trials completed
Standard Dose Versus High Dose and Versus Extended Standard Dose Radium-223 Dichloride in Castration-resistant Prostate Cancer Metastatic to the Bone NCT02023697 · started 2014 · scored riskier than 26% 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.