Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer (NCT02766478), a randomized phase 2 study. The primary outcome is Matsuda Index of Whole-Body Insulin Sensitivity at Baseline and Week 8 Post-baseline.

2. Clinical Question

3. Trial Design

This is a Phase 2 randomized, double-masked, parallel-group trial sponsored by Emory University. The registry lists prostate cancer as the condition and genistein and placebo as the interventions. In a parallel design, participants are assigned to one group and receive that group’s intervention rather than crossing over between treatments. Randomization is intended to support a fair comparison, while masking is intended to limit effects of knowing the assigned intervention. Those general purposes do not establish how well either feature was implemented in this trial; procedural details are not reported in the registry record.

Participants assigned to genistein were to take 60 mg/day orally, as 30 mg twice daily, for 12 weeks. The placebo group was to take placebo twice daily for 12 weeks. The brief summary describes men receiving androgen deprivation therapy for prostate cancer and says that participants with and without diabetes were included. The record does not report the number in each diabetes category.

The registry lists a start date of 2017-10-16 and a primary completion date of 2021-07-23. Its status is TERMINATED. The reason for termination, the date of termination, and whether all planned assessments were completed are not reported in the registry record. The enrollment field records 10, whereas the brief summary describes a project involving 24 men. The record does not reconcile those figures, so they should not be treated as interchangeable measures of recruitment or completion.

The primary outcome was assessed at baseline and Week 8 post-baseline, while treatment was described as lasting 12 weeks. The relationship between that outcome assessment and the end of treatment is not explained further in the registry record. Secondary outcomes include arterial stiffness and vascular endothelial function at baseline and Week 8 post-baseline. The registry record identifies four outcome measures overall but does not provide their analysis results.

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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Number of patients included only subjects that were able to complete the outcome assessment in each visit.

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.

6. Primary Endpoint

The registry lists the primary outcome as Matsuda Index of Whole-Body Insulin Sensitivity at Baseline and Week 8 Post-baseline, measured over Baseline, Week 8 post-baseline.

The primary endpoint is the Matsuda index of whole-body insulin sensitivity, assessed at baseline and Week 8 post-baseline. The registry describes it as calculated from plasma glucose and insulin concentrations collected during an oral glucose tolerance test. Higher index values are described as reflecting better insulin sensitivity. The index is used as a continuous measure of insulin response rather than as a clinical diagnosis.

As a general statistical point, a continuous measure can capture variation across participants without first dividing them into categories. That can be useful when the measurement reflects a biological process of interest. However, the clinical meaning of a given value depends on how the measure has been validated and interpreted. The registry specifically says this test is not used to clinically diagnose disease and that there is no accepted standard cutoff for impaired insulin sensitivity or insulin resistance based on this index. The endpoint therefore cannot, by itself, classify a participant as having or not having a clinical condition.

The outcome is summarized using the median and interquartile range. The median describes the middle of the observed distribution, while the interquartile range describes the spread of its central portion. These summaries can be informative when measurements are skewed or include values that make the mean less representative. The registry record does not report the median or interquartile range at either visit, nor a change estimate or comparison between treatment groups. The endpoint’s measurement rationale can therefore be described, but its observed pattern and precision cannot be assessed from the recorded information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measure is reported as a median with an interquartile range, rather than as a mean with a standard deviation. As a general statistical explanation, the median is the value at the center of ordered observations. The interquartile range describes the spread of the central half of those observations. These summaries are often useful when data are asymmetric or when unusually high or low observations could strongly influence a mean. They do not, on their own, quantify uncertainty in a treatment-group effect. For that, a comparison estimate and an uncertainty measure, such as a confidence interval, would be needed. Such a comparison is not reported in the registry record.

A confidence interval, in general, describes a range of values compatible with the observed data under a specified statistical procedure. Its width communicates precision: wider intervals indicate less precision than narrower intervals. A confidence interval does not establish that an effect is clinically important, and interpretation depends on the outcome scale and the question being asked. The registry record does not report a confidence interval for the Matsuda index or for any treatment contrast.

The endpoint is assessed at baseline and Week 8 post-baseline. A comparison could, in general, focus on the value at follow-up, change from baseline, or a model that accounts for baseline and follow-up together. Those choices can produce different estimates and rely on different assumptions. The analysis approach selected for this trial is not reported in the registry record. It is therefore not possible to say whether the posted analysis would have adjusted for baseline, how repeated observations were handled, or what model assumptions were used.

The record describes the primary outcome population as only subjects able to complete the assessment at each visit. In general, analyzing only participants with observed measurements can be straightforward to describe, but it can create bias if the likelihood of having a measurement is related to the outcome or assigned group. Methods for missing data depend on why observations are missing and on assumptions about the unobserved values. The registry record does not report the number missing at each visit, reasons for missingness, imputation methods, or sensitivity analyses. No claim about the direction or size of potential missing-data bias can be made from the available description.

Randomization and masking are recorded, but details about the randomization sequence, concealment, and masking procedures are not reported in the registry record. In general, random assignment helps make groups comparable at the start in expectation, while concealment and masking can reduce certain sources of bias. Neither feature guarantees that the groups remain comparable in a small study, that outcome measurements are complete, or that an analysis is free from bias. The record does not report baseline balance statistics or an analysis adjusting for participant characteristics.

The registry identifies four outcome measures and zero analysis entries. Multiple outcomes or multiple assessments can raise multiplicity concerns. As a general statistical concept, when many hypotheses are examined, the chance of at least one apparently unusual result can increase unless the analysis plan accounts for the number and structure of comparisons. A prespecified primary outcome can help focus interpretation, but details of any multiplicity strategy are not reported in the registry record. The primary outcome’s baseline and Week 8 time points are not reduced to one comparison in the available record.

The registry’s sample-size planning assumptions describe a planning illustration based on the observed effect, not the trial’s own design. The illustration is described as using a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect stated as a fraction of the observed effect. No planning sample-size values or observed effect estimate are included in the registry record. Such planning figures, even when available, would be illustrations rather than observed power. They would not reveal the probability that the completed trial detected an effect, nor replace an estimate and confidence interval based on the posted results.

The registry record does not report a p-value or a formal test for the primary outcome. A p-value, in general, measures how unusual data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the test assumptions held. It does not measure the probability that the null hypothesis is true, nor the size or clinical importance of an effect. In the absence of the test result and a treatment-effect estimate, statistical significance cannot be assessed. No recalculated comparison is available in the registry record, so there is no sponsor-versus-recalculation discrepancy to interpret.

Finally, general interpretation of a treatment comparison depends on the analysis population and the estimand: the precise effect the analysis is intended to estimate. Analyses based on all randomized participants and analyses limited to those with completed assessments answer different questions and may yield different results. The registry record does not report an intention-to-treat analysis, a per-protocol analysis, or another defined analysis population beyond its description of the outcome-assessment population. These methods cannot be attributed to the trial without a reported analysis plan or results.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures, including the Matsuda index and secondary measures of arterial stiffness and vascular endothelial function. It records zero analysis entries. The primary outcome is assessed at baseline and Week 8 post-baseline, and the record does not reduce the outcome’s multiple categories or time points to one reported comparison. A multiplicity adjustment or other strategy for handling multiple outcomes and assessments is not reported in the registry record.

As a general statistical issue, examining multiple outcomes or time points can make isolated results harder to interpret because the number of opportunities to observe an unusual result increases. Prespecifying a primary outcome can help distinguish the main question from supporting questions, but it does not reveal whether a particular statistical adjustment was planned or applied. The record does not report an analysis plan or a family of hypotheses that would allow the multiplicity approach to be assessed.

For the primary endpoint, the registry says that the reported population includes only subjects able to complete the assessment at each visit. The number of participants contributing data at each visit, reasons for incomplete assessments, and methods for handling missing outcomes are not reported in the registry record. It is not stated whether missing values were imputed or whether sensitivity analyses were performed.

The analysis population beyond that outcome-assessment description is not reported in the registry record. In particular, the record does not specify whether all randomized participants were included in a primary analysis or whether a separate analysis population was used. Without participant flow and analysis details, the effects of exclusions or missingness cannot be evaluated. These omissions limit both the reproducibility of the analysis and the ability to judge how broadly any eventual estimate would apply.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports serious adverse events for the genistein group with 6 at risk and 0 affected, and for the placebo group with 4 at risk and 0 affected. Deaths are recorded as 0 in each group. For other adverse events, the record lists 5 affected among 6 at risk in the genistein group and 4 affected among 4 at risk in the placebo group. These are counts from the registry record, not estimates of a treatment effect.

Serious adverse events and other adverse events are reported separately. A count of zero serious events means none were recorded in the listed group during the registry’s safety reporting period; it does not establish that the risk is absent. The denominators are small, so the counts alone provide limited information about how frequently events might occur in a larger population. No event terms are listed among the top serious-event terms.

The record does not provide a statistical comparison, event descriptions for the other adverse events, timing, severity, or an explanation of how events were collected. The counts therefore cannot establish whether one intervention caused more events than the other. They also do not answer the primary question about insulin sensitivity. Interpretation should remain limited to the specific counts and reporting details recorded.

12. What the Result Does, and Does Not, Mean

The registry record describes a randomized, double-masked comparison of genistein and placebo in men receiving androgen deprivation therapy for prostate cancer. It specifies the dosing schedules and identifies the Matsuda index at baseline and Week 8 post-baseline as the primary outcome. These details establish what the study was designed to examine, but they do not show what happened to the outcome in either group.

The actual primary-outcome summaries and a between-group estimate are not reported in the registry record. There is no reported confidence interval or p-value for the primary comparison. As a result, the record does not establish the direction, magnitude, or precision of a difference in insulin sensitivity. This absence of a reported comparison should not be interpreted as evidence that the groups were the same, or that genistein did or did not affect the outcome.

The endpoint also has a defined interpretive limit: the registry states that the Matsuda index is not a clinical diagnostic test and that no accepted standard cutoff defines impaired insulin sensitivity or insulin resistance from this index. Even if numerical results were available, they would need to be interpreted as changes in a measurement rather than as a diagnosis or direct statement about clinical outcomes.

The safety entries describe no serious adverse events or deaths in either listed group, alongside other adverse-event counts in both groups. Given the limited counts and absence of a comparative analysis or event details, those entries do not establish a safety advantage or disadvantage. They should be read as registry-reported observations rather than definitive evidence about risk.

The study’s TERMINATED status, enrollment field of 10, and the brief summary’s description of a project involving 24 men are relevant context, but the record does not explain the termination or reconcile the enrollment figures. The resulting uncertainty about recruitment and outcome completion reinforces the need to avoid extrapolating beyond the record. The available information supports describing the trial’s design and its reporting gaps, not making a claim about whether genistein changes cardiometabolic outcomes.

13. Why This Trial Matters Statistically

This trial raises a statistically important question about how to evaluate a biomarker-based endpoint in a clinical setting. The Matsuda index summarizes insulin sensitivity from glucose and insulin measurements during an oral glucose tolerance test. The registry gives a clear direction for interpretation of the scale—higher values reflect better insulin sensitivity—but also notes that the index is not a diagnostic test and has no accepted standard cutoff for impaired insulin sensitivity or insulin resistance. Statistical differences in a measure and clinically meaningful differences are not automatically the same thing.

The record also highlights how the endpoint’s analysis population affects interpretation. The description includes only subjects able to complete the assessment at each visit. Without visit-specific counts and a missing-data strategy, readers cannot tell how much information contributed to the outcome summaries or whether completion was related to participant characteristics, group assignment, or the outcome itself. These details matter because an apparently precise summary from assessed participants may not answer the same question as an analysis of all randomized participants.

Multiple outcomes and assessment times create another interpretive issue. The record lists four outcome measures and does not reduce the primary outcome’s time points to a single reported comparison. Without an analysis plan or multiplicity strategy, it is difficult to distinguish confirmatory findings from exploratory patterns even if estimates were available. In this record, the numerical comparisons themselves are not reported, making that distinction impossible.

Finally, the registry’s enrollment and summary descriptions do not match, and the trial is marked TERMINATED without a reported reason. Those details do not establish why the study ended or how its results were affected, but they underscore why recruitment, completion, and analysis details are essential to a reliable statistical interpretation. The record is useful for identifying the intended question and the information needed to answer it; it does not provide the outcome analysis required to resolve that question.

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 main trial-specific limitation is that the registry record does not report primary-outcome values or a comparison between the genistein and placebo groups. It gives the outcome definition, scale direction, summary measure, and assessment times, but no medians, interquartile ranges, changes, confidence intervals, or p-values. This prevents assessment of the observed effect and its precision.

The trial is marked TERMINATED, but the reason, timing, and consequences of termination are not reported in the registry record. The enrollment field records 10, while the brief summary describes a project involving 24 men. The record does not explain whether these refer to different recruitment targets or stages, so the discrepancy cannot be resolved from the registry information.

The primary-outcome population is described as participants able to complete the measure at each visit, but the number assessed at each visit is absent. Reasons for missing measurements, handling of missing data, participant flow, and the analysis population are not reported in the registry record. The registry also contains no analysis entries, leaving the statistical model, baseline adjustment, and approach to repeated measurements unspecified.

The outcome is assessed at baseline and Week 8, whereas treatment is described as lasting 12 weeks. The record does not explain this timing relationship further. It also does not report the randomization method, masking procedures, multiplicity approach, or sample-size justification for the trial itself. The planning assumptions described in the record are an illustration based on an observed effect, not a statement of the trial’s original design; no resulting planning figures are included. These omissions limit reconstruction and interpretation of the trial, but they do not establish that any particular method was or was not used.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer — NCT02766478.
• Registry record last updated 2022-09-27; status last verified 2022-09.
• Results first posted 2022-09-27.
• 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.

18. Record Summary

The registry identifies NCT02766478 as a randomized, double-masked, parallel Phase 2 trial sponsored by Emory University. It is marked TERMINATED and lists an enrollment of 10. The brief summary describes a project involving 24 men, a difference the registry record does not explain.

The comparison was oral genistein, 60 mg/day in two daily doses for 12 weeks, versus placebo twice daily for 12 weeks. The primary outcome was the Matsuda index at baseline and Week 8 post-baseline, summarized as a median and interquartile range. The record does not report the outcome values or a group comparison. It lists arterial stiffness and vascular endothelial function as secondary outcomes and records four outcome measures overall, with zero analysis entries.

The registry reports no serious adverse events or deaths in either group, and reports other adverse events in both groups. The reason for termination, analysis methods, missing-data handling, and detailed outcome results are not reported in the registry record.