Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT

NCT03777982 on ClinicalTrials.gov Phase 3 Dana-Farber Cancer Institute (academic or other) Started 2020-04-20 Terminated

Riskier than 60% of active trials

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (607 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2024-02-13, after 2020-04-20 start.

Reason given by the sponsor: “enrollment”

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 2024-02-13. 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: longventriculartermradiationheart
Phrases that lowered it: impairmentmlparticipantspatients whoinvestigator
Sponsor's past termination rate: 18.2% (raises risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Has a data monitoring committee: Yes (raises risk) · Design
Trials the sponsor started in the prior 2 years: 78 (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Sponsor's past trials: 329 (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 73.7% (lowers risk) · Drug's FDA history
Sponsor type: academic or other (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 11.2% (lowers risk) · Drug's FDA history
Drug's FAERS reports before start: 290048 (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 51810 (lowers risk) · Drug's FDA history
Responsible party: principal investigator (lowers risk) · Design
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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 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: 329 (typical: 32)
Sponsor's past termination rate: 18.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 78 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 290048 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 51810 (typical: 412.5)
Drug's FAERS reports marked serious: 73.7% (typical: 85.6%)
Drug's FAERS reports with a death: 11.2% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital
Drugs matched to FDA substances: abiraterone, apalutamide, prednisone

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

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A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy NCT02849990 · started 2017 · scored riskier than 73% of active trials completed
Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy NCT02903368 · started 2016 · scored riskier than 73% of active trials completed
A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer NCT03009981 · started 2017 · scored riskier than 47% of active trials completed
Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer NCT03279250 · started 2017 · scored riskier than 86% 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.