This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (NCT05288166), a randomized phase 3 study. The primary outcome is Radiographic Progression-Free Survival (rPFS) Assessed by Investigator.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05288166 |
| Phase | Phase 3 |
| Condition | Prostatic Neoplasms, Neoplasm Metastasis, Urogenital Neoplasms |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 925 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Men with high-risk metastatic hormone-sensitive prostate cancer. The registry title describes cancer that has spread and is expected to respond to hormonal treatment. The primary endpoint population is described as all randomized participants, including participants whose endpoint observations were censored.
Intervention
Abemaciclib added to abiraterone plus prednisone. The described regimen used 200 mg abemaciclib twice daily, with 1000 mg abiraterone acetate once daily and 5mg prednisone twice daily, administered orally on a continuous schedule during 28-day cycles.
Comparator
Placebo for abemaciclib, added to abiraterone plus prednisone. The placebo arm is described as receiving 1000 mg abiraterone acetate once daily and 5mg prednisone twice daily on the same stated continuous schedule.
Primary question
Does adding abemaciclib change the time from randomization to investigator-determined radiographic progression or death from any cause? The primary measure is radiographic progression-free survival (rPFS), reported as a median in months with a 95% confidence interval. The registry record does not report the estimated medians or confidence intervals, so the posted primary result does not quantify a between-group difference.
The study addresses the incremental contribution of abemaciclib within a regimen that includes abiraterone and prednisone. It is not a comparison of the full combination against no treatment, nor does the registry description make the effect of any single medicine separable from the other treatment components. The randomized comparison is between assignment to abemaciclib and assignment to placebo, with the other named medicines included in both arms.
The title identifies the population as men with high-risk metastatic hormone-sensitive disease. The brief summary describes the study purpose as learning whether adding abemaciclib prolongs the time before the cancer gets worse. That stated aim is a research question, not a reported finding. The record lists secondary outcomes including rPFS assessed by blinded independent central review, castration-resistant prostate cancer-free survival, overall survival, pain progression, quality-of-life deterioration, and pharmacokinetics. Their listing does not establish that results are available.
3. Trial Design
CYCLONE 3 is a phase 3, randomized, double-blind, placebo-controlled, parallel-group study sponsored by Eli Lilly and Company. The registry lists enrollment as 925. The abemaciclib arm is listed with 463 participants and the placebo arm with 462. These are registry arm figures; the adverse-event summaries use separate at-risk counts and should not be assumed to have identical denominators.
Participants were assigned to abemaciclib or placebo while receiving abiraterone and prednisone. In the abemaciclib arm description, the oral regimen is 200 mg twice daily, plus 1000 mg abiraterone acetate once daily and 5mg prednisone twice daily. The placebo description gives the same stated abiraterone and prednisone doses with placebo twice daily. The descriptions refer to continuous dosing on days 1 through 28 of a 28-day cycle, continuing until progression or another discontinuation circumstance. The placebo description is truncated in the registry record, so its full stopping language is not reported there.
The study started on 2022-04-14, and the listed primary completion date is 2024-02-15. Its status is active, not recruiting. The brief summary says participation may last approximately 60 months. These record details describe study conduct and status; they do not supply an efficacy result.
Randomization supports a comparison based on assigned treatment, while double masking is intended to limit knowledge of assignment during the study. The record does not report the randomization procedure, allocation concealment details, stratification factors, or how masking was maintained. Those design details are not reported in the registry record. No conclusions about the integrity or success of masking should be inferred from the design label alone.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Completers included participants who had an event (radiographic progression or death) and participants who were off the treatment and were alive at study conclusion.
Overall Study
| Stage | Abemaciclib | Placebo |
|---|---|---|
| STARTED | 463 | 462 |
| Received at Least One Dose of Study Drug | 460 | 460 |
| COMPLETED | 47 | 39 |
| NOT COMPLETED | 416 | 423 |
Reasons for not completing this period:
| Reason | Abemaciclib | Placebo |
|---|---|---|
| Adverse Event | 1 | 0 |
| Lost to Follow-up | 2 | 0 |
| Physician Decision | 0 | 2 |
| Screen Failure | 1 | 1 |
| Withdrawal by Subject | 4 | 2 |
| On Study Treatment | 408 | 418 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants (including the censored participants). Number of participants censored in "Abemaciclib = 385," "Placebo = 389."
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: All randomized participants.
| Characteristic | Unit | Abemaciclib | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 463 | 462 | 925 | |
| Age, Continuous | years | 68.80 (SD 8.16) | 69.30 (SD 8.07) | 69.00 (SD 8.11) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 463 | 462 | 925 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 115 | 126 | 241 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 276 | 271 | 547 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 72 | 65 | 137 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 27 | 27 | 54 |
| Race (NIH/OMB): Asian | Participants | 122 | 120 | 242 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 17 | 15 | 32 |
| Race (NIH/OMB): White | Participants | 278 | 286 | 564 |
| Race (NIH/OMB): More than one race | Participants | 9 | 5 | 14 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 9 | 9 | 18 |
| Region of Enrollment: Argentina | Participants | 40 | 39 | 79 |
| Region of Enrollment: Australia | Participants | 28 | 29 | 57 |
| Region of Enrollment: Belgium | Participants | 3 | 0 | 3 |
| Region of Enrollment: Brazil | Participants | 46 | 53 | 99 |
| Region of Enrollment: Canada | Participants | 1 | 1 | 2 |
| Region of Enrollment: China | Participants | 65 | 70 | 135 |
| Region of Enrollment: Czechia | Participants | 15 | 11 | 26 |
| Region of Enrollment: France | Participants | 14 | 9 | 23 |
| Region of Enrollment: Germany | Participants | 24 | 22 | 46 |
| Region of Enrollment: Greece | Participants | 2 | 4 | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Radiographic Progression-Free Survival (rPFS) Assessed by Investigator, measured over From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (up to 22 months).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is investigator-assessed radiographic progression-free survival (rPFS), measured in months. For each participant, the time begins at randomization and ends at the earliest of investigator-determined radiographic disease progression or death from any cause. Progression is based on objective radiographic assessment: RECIST version 1.1 for soft-tissue disease and/or radionuclide bone scanning using PCWG3 criteria for bone disease.
Time-to-event endpoints are used when the question concerns how long it takes for an event to occur, rather than whether it has occurred by a single fixed visit. They can incorporate participants whose event has not been observed by the end of their available follow-up, using censoring to represent incomplete event-time information. General statistical point: censoring does not mean that a participant had no event; it means that the event time is not observed within the available follow-up.
The registry specifies a median and a 95% confidence interval as the endpoint summary, with a timeframe of up to 22 months. A median event time describes the point by which half of the estimated event-time distribution has experienced the event, under the analysis method used. The confidence interval communicates uncertainty around that estimate. The registry record contains no median values or confidence limits for either arm, so the primary endpoint cannot be interpreted as a numerical treatment comparison from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical limitation is that the registry record gives no primary rPFS estimate for either treatment group. The arm entries have no reported endpoint values or confidence limits, and the record indicates that values are missing or not estimable for a two-arm comparison of this median time endpoint. Consequently, the posted results do not show whether the estimated median rPFS was longer in one arm, how large any difference may have been, or how precise an estimate would be.
This is not the same as a result showing no difference. Missing or non-estimable values do not establish that the treatments had equal outcomes, and they do not establish that either treatment was better. A comparison would require an effect estimate and its uncertainty, or another suitable reported analysis. No such primary comparison is posted in the registry record. The record also lists zero analyses, so there is no reported hazard ratio to use as an alternative time-to-event comparison.
The endpoint population is described as all randomized participants, including censored participants. The record gives censored counts of 385 in the abemaciclib group and 389 in the placebo group. Censoring is part of time-to-event analysis, but those counts alone do not reveal when censoring occurred, why follow-up ended, or how the event-time curves behaved. They also do not replace the absent endpoint estimates.
The registry's planned timeframe is up to 22 months, while the overall study participation may last approximately 60 months. These refer to different descriptions in the record and should not be treated as interchangeable measures of follow-up. The dates and status indicate that the record lists a primary completion date of 2024-02-15 and a status of active, not recruiting; neither fact supplies the missing result.
The serious adverse-event summaries are descriptive counts, not substitutes for the primary efficacy endpoint. They show reported counts within the listed at-risk groups, but the registry record does not provide a full account of event timing, exposure duration, or adjusted comparative analyses. Raw counts should therefore be read as registry summaries rather than as complete measures of comparative risk.
Overall, the posted information supports describing the trial design, endpoint definition, censoring, and selected adverse-event counts. It does not support a numerical conclusion about the primary treatment effect. Any planning illustrations based on an observed effect would also be unavailable or inapplicable when the relevant effect estimate is not reported; such illustrations, when present, are planning calculations rather than observed power or trial findings.
9. Statistical Methods Explained
What does a median time-to-event result represent?
General statistical explanation: a time-to-event analysis studies the duration from a defined starting point until an event. In this trial, the clock starts at randomization, and the event is radiographic progression or death, whichever occurs first. Reporting the median expresses a point in the estimated distribution of event times. It is different from reporting the average duration, and it does not describe the timing of every participant's event.
The median is useful because it gives a readily interpretable time summary when follow-up includes participants with different observation lengths. It can be difficult to estimate or compare if too few events have occurred or if the relevant portion of the event-time distribution is not observed. The registry record does not state why the medians are missing or not estimable, so no particular explanation should be assumed for this trial.
What does censoring mean?
General statistical explanation: a participant is censored when the event has not been observed by the last available follow-up or observation time. The exact handling depends on the analysis method. Censoring preserves partial information about event time, but it does not mean that the participant remained event-free indefinitely. A valid analysis relies on assumptions about how censoring relates to the chance of the event, and the registry record does not report the censoring assumptions or detailed censoring rules.
The registry describes the primary endpoint population as all randomized participants, including those censored. It reports 385 censored participants in the abemaciclib group and 389 in the placebo group. These counts provide context but do not reveal follow-up duration, reasons for censoring, event counts, or the distribution of event times. They cannot be used alone to reconstruct a median or a treatment comparison.
Why are confidence intervals important?
General statistical explanation: a confidence interval describes the uncertainty associated with an estimate under the analysis procedure. A narrower interval indicates greater precision under that procedure; a wider interval indicates less precision. It is not a guarantee that the true effect lies within a particular interval. The registry identifies a 95% confidence interval as the intended dispersion measure for the median, but reports no interval limits. Without both an estimate and its uncertainty, the precision of the primary result cannot be assessed.
How should a between-group comparison be assessed?
For a time-to-event question, analysts may report a hazard ratio or compare estimated event-time curves, subject to the specified analysis plan and assumptions. General statistical explanation: a hazard ratio compares event rates over time between groups, and its interpretation depends on the model and assumptions used. A hazard ratio is not the same quantity as a difference between medians. No sponsor-reported hazard ratio or other primary comparative estimate appears in the posted results, and the record lists zero analyses. It would therefore be inappropriate to create a comparison from the arm sizes or censoring counts.
The registry defines progression using investigator assessment and specified imaging criteria. It separately lists rPFS assessed by blinded independent central review as a secondary outcome. These are different assessment approaches, and their results should not be conflated. No central-review estimate is reported in the posted information described in the record. The available information also does not state how disagreements between investigators and central reviewers would be handled.
What can safety counts establish?
General statistical explanation: adverse-event counts describe events recorded under a defined collection process. To compare groups appropriately, readers need to understand the event definitions, observation period, exposure, and denominator. A simple count does not account for different exposure time or establish that treatment caused an event. The registry lists serious events and other adverse events using at-risk groups of 460 per arm, as well as deaths. These are descriptive summaries and are not an adjusted safety comparison.
The record lists pneumonia, urinary tract infection, anaemia, hypokalaemia, acute kidney injury, and fatigue among the leading serious-event terms, with percentages attached to each term. It does not clarify in the available record whether these percentages are pooled or arm-specific, so they should not be assigned to an arm. No inferential comparison, confidence interval, or event-time analysis is reported for these terms.
What is not specified about the statistical plan?
The registry record does not report the primary analysis model, a formal hypothesis-testing procedure, the planned handling of missing observations beyond the endpoint's censoring description, or an interim-analysis plan. It also does not report a sample-size justification. General statistical explanation: a sample-size calculation depends on design assumptions and a target effect; it is not a statement about the power achieved after a study is conducted. Any planning illustration based on an observed effect would be distinct from the trial's original design and from observed power. The record does not provide such a reported effect for this primary endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven secondary outcomes, in addition to the primary endpoint. They include rPFS assessed by blinded independent central review, castration-resistant prostate cancer-free survival, overall survival, time to pain progression, two measures of health-related quality-of-life deterioration, and abemaciclib maximum plasma concentration at steady state. Listing several outcomes raises a general statistical issue: examining multiple outcomes can increase the chance of at least one apparently notable result unless the analysis plan addresses multiplicity. The registry record does not report a multiplicity-control strategy, testing hierarchy, or allocation of significance levels.
The record lists no analyses, and it does not provide numerical results for the primary endpoint. The secondary outcome names therefore should be read as registered measures, not as evidence of results. Their analysis estimates, confidence intervals, and statistical tests are not reported in the registry record.
The primary endpoint description includes censored participants in the stated population and gives censored counts for each arm. It does not report additional details about missing data, reasons for censoring, sensitivity analyses, or how other missing measurements were handled. The endpoint population is described as all randomized participants, but the registry record does not specify further analysis populations, such as a per-protocol set or a safety population definition.
These omissions limit assessment of how the statistical plan protected against selective interpretation and how robust any eventual result might be to missingness. They do not show that such procedures were absent from the full study conduct; those details are simply not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Abemaciclib | 145 | 460 | 31.5% |
| Placebo | 68 | 460 | 14.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Abemaciclib | 47 of 460 |
| Placebo | 32 of 460 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Abemaciclib | 445 of 460 |
| Placebo | 380 of 460 |
Most frequent serious adverse event terms
| Event term | Organ system | Abemaciclib | Placebo |
|---|---|---|---|
| Pneumonia | Infections and infestations | 19 of 460 | 4 of 460 |
| Urinary tract infection | Infections and infestations | 11 of 460 | 3 of 460 |
| Hypokalaemia | Metabolism and nutrition disorders | 9 of 460 | 3 of 460 |
| Anaemia | Blood and lymphatic system disorders | 9 of 460 | 0 of 460 |
| Myocardial infarction | Cardiac disorders | 4 of 460 | 4 of 460 |
| Fatigue | General disorders | 7 of 460 | 1 of 460 |
| Covid-19 | Infections and infestations | 5 of 460 | 3 of 460 |
| Acute kidney injury | Renal and urinary disorders | 8 of 460 | 0 of 460 |
| Cardiac failure | Cardiac disorders | 5 of 460 | 2 of 460 |
| Atrial fibrillation | Cardiac disorders | 4 of 460 | 2 of 460 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Abemaciclib | Placebo |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 301 of 460 | 62 of 460 |
| Anaemia | Blood and lymphatic system disorders | 252 of 460 | 58 of 460 |
| Fatigue | General disorders | 178 of 460 | 91 of 460 |
| Neutropenia | Blood and lymphatic system disorders | 217 of 460 | 13 of 460 |
| Hypokalaemia | Metabolism and nutrition disorders | 133 of 460 | 63 of 460 |
| Hot flush | Vascular disorders | 69 of 460 | 98 of 460 |
| Nausea | Gastrointestinal disorders | 116 of 460 | 41 of 460 |
| Blood creatinine increased | Investigations | 130 of 460 | 17 of 460 |
| Alanine aminotransferase increased | Investigations | 63 of 460 | 77 of 460 |
| Thrombocytopenia | Blood and lymphatic system disorders | 125 of 460 | 14 of 460 |
Serious events with the highest arm-level rate: pneumonia (4.1%), urinary tract infection (2.4%), anaemia (2.0%), hypokalaemia (2.0%), acute kidney injury (1.7%).
The registry reports serious adverse events in groups with 460 participants at risk in each arm. Serious adverse events affected 145 participants in the abemaciclib group and 68 in the placebo group. Other adverse events affected 445 participants in the abemaciclib group and 380 in the placebo group, using the same stated at-risk counts. Deaths are listed as 47 and 32, respectively. These are raw registry counts; they are not adjusted comparisons and do not show when events occurred or how long participants were exposed.
The record lists pneumonia (4.1%), urinary tract infection (2.4%), anaemia (2.0%), hypokalaemia (2.0%), acute kidney injury (1.7%), and fatigue (1.5%) among the leading serious-event terms. The available information does not identify these percentages as belonging to a specific arm, so they should not be interpreted as arm-specific estimates.
General statistical point: counts can be affected by follow-up duration, treatment exposure, event definitions, and repeated events in the same participant. A participant count and an event count are not necessarily interchangeable. The registry summary does not provide event-level detail, exposure-adjusted rates, uncertainty intervals, or a formal comparative safety analysis. These figures describe the posted safety summaries only; they do not by themselves establish causation or a treatment effect.
12. What the Result Does, and Does Not, Mean
The registry record establishes that CYCLONE 3 is a randomized, double-blind, placebo-controlled phase 3 comparison of abemaciclib versus placebo, with both groups receiving abiraterone and prednisone. It also defines investigator-assessed rPFS as the primary endpoint and identifies how radiographic progression and death contribute to that endpoint. These details clarify the research question and the intended type of outcome.
What the posted results do not establish is the primary outcome's magnitude or direction. The medians and 95% confidence intervals are absent, and no comparative analysis is listed. It is therefore not possible from these results to determine whether rPFS differed between groups, to quantify any difference, or to assess its precision. Missing estimates are not evidence of equal outcomes, and they do not show that a treatment had no effect.
The record also lists secondary outcomes, but does not give their results in the information described. The adverse-event counts offer descriptive information for the listed at-risk groups; they do not constitute a complete causal or adjusted comparison. The listed serious-event percentages cannot be assigned to a particular arm based on the record description.
General statistical interpretation requires matching conclusions to the available estimand and uncertainty. A median time, a hazard ratio, and a fixed-time event proportion answer related but distinct questions. They cannot be substituted for one another without suitable data and an analysis plan. In this case, no primary estimate is available to interpret, and no new effect estimate can be derived from the enrollment figures or censoring counts.
Thus, the record is informative about design and measurement but insufficient for an efficacy conclusion. A fuller results report would be needed to assess the primary treatment comparison, the uncertainty around it, secondary outcomes, and the context of missing observations and safety findings.
13. Why This Trial Matters Statistically
This trial poses a clear statistical question: whether adding abemaciclib to a shared abiraterone-plus-prednisone regimen changes investigator-assessed time to radiographic progression or death. Randomization and a placebo control are relevant to that comparison because the assigned groups differ in the study drug under evaluation while sharing the named background medicines. The phase 3 designation and enrollment listing describe the scale and stage of the registered study, but do not themselves provide evidence about the endpoint result.
The endpoint also illustrates why time-to-event methods are important in clinical research. Participants may have different lengths of observation, and some may be censored before the event is recorded. A median with a confidence interval can convey an interpretable summary and its precision when estimable. In this registry record, the endpoint definition and censoring counts are present, but the estimates needed to answer the research question are not.
The contrast between a carefully described design and absent outcome estimates is statistically important. Readers should distinguish the planned comparison from a reported finding and should not treat enrollment or event counts as a proxy for treatment effect. The record's listed secondary outcomes and adverse-event summaries further illustrate that outcome names and descriptive counts do not substitute for prespecified comparative analyses with uncertainty.
For clinical researchers and biostatisticians, the record highlights the value of complete results reporting: effect estimates, confidence intervals, analysis methods, missing-data handling, and multiplicity procedures. Without those elements, the study's main comparative question remains unresolved by the posted results, even though the trial design and endpoint are described.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most consequential limitation for interpretation is the absence of primary rPFS estimates and confidence intervals. The record gives no arm-specific median values and no comparative estimate. It also provides no listed analyses. The reason the endpoint values are missing or not estimable is not reported in the registry record, so the absence cannot be attributed to a particular event pattern, follow-up issue, or reporting decision.
The endpoint was assessed by investigators, while blinded independent central review appears as a separate secondary outcome. The record does not provide a central-review result or explain how the two assessment approaches were reconciled. The primary timeframe is described as up to 22 months, but detailed follow-up distributions and event counts are not reported. Censored counts are available, but the record does not state reasons for censoring or provide sensitivity analyses.
The statistical analysis plan is also not sufficiently detailed in the registry record to evaluate the planned model, hypothesis tests, multiplicity control, interim analyses, or sample-size justification. These details are not reported in the registry record. Their absence from this record does not prove that they were not addressed elsewhere, but it limits independent statistical assessment of the posted information.
Safety information is limited to selected counts and serious-event terms. The record does not provide exposure-adjusted rates, event timing, confidence intervals, or a formal comparative analysis. The group descriptions for the leading serious-event percentages are not explicit, and the placebo arm's stopping description is truncated. These limitations counsel against interpreting the available safety figures as complete treatment-attributable risks.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) — NCT05288166.
- Registry record last updated 2026-07-01; status last verified 2026-06.
- Results first posted 2025-06-27.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
CYCLONE 3 (NCT05288166) is a randomized, double-blind, placebo-controlled, parallel-group phase 3 study sponsored by Eli Lilly and Company. It compares abemaciclib with placebo when added to abiraterone and prednisone in men with high-risk metastatic hormone-sensitive prostate cancer. Registry enrollment is 925, with arm listings of 463 for abemaciclib and 462 for placebo.
The primary endpoint is investigator-assessed rPFS, measured from randomization to radiographic progression or death from any cause. The registry record does not report the median estimates or 95% confidence intervals, and lists no analyses. The record lists secondary outcomes and descriptive adverse-event counts, but these do not provide a primary efficacy comparison.
The study started on 2022-04-14, has a listed primary completion date of 2024-02-15, and is active, not recruiting. The posted information describes the trial design and endpoint but does not establish the direction, size, or precision of the primary treatment effect.