Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic Prostate Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic Prostate Cancer (NCT00669162), a na phase 1, phase 2 study. The primary outcome is Percentage of Patients Who Can Safely Tolerate and Complete Adjuvant Hormonal Therapy, Radiation Therapy and Docetaxel After a Radical Prostatectomy.

2. Clinical Question

The study concerns patients with high-risk pathologic prostate cancer after radical prostatectomy and lymph node sampling. Its central question is whether patients can complete postoperative radiation therapy, concurrent docetaxel, and hormonal therapy within the stated follow-up period. The registry’s primary endpoint title refers to safely tolerating and completing all three therapies, while the endpoint definition specifically measures completion of the full radiation dose. That difference matters: the title describes a broader treatment-completion question than the operational definition.

This is a feasibility and treatment-completion question rather than a randomized estimate of the difference between treatment strategies. The registry record does not report a numerical primary-endpoint result, so the percentage who completed the full radiation dose cannot be assessed from the posted results.

3. Trial Design

The registry lists this study as Phase I/II and completed. It is a single-group study with no masking; allocation is recorded as NA. The University of Kansas Medical Center is listed as sponsor. The study start is recorded as 2012-08 and primary completion as 2016-08. Enrollment is reported as 27.

Participants were to receive treatment after radical prostatectomy and lymph node sampling. The intervention combined postoperative radiation therapy with concurrent docetaxel and hormonal therapy. The radiation regimen is described as 66 Gy in 33 treatment fractions at 2.0 Gy per fraction. Docetaxel is described as 20 mg/m2 weekly for 7 weeks during radiation. Hormonal therapy is described as Casodex, 50 mg orally daily for 6 months, together with either Zoladex, 10.8 mg subcutaneously every 3 months for 2 doses, or Lupron, 22.5 mg intramuscularly every 3 months for 2 doses.

Because there is only one study group, the design does not directly compare the combined regimen with another treatment or with no treatment. Observed outcomes can describe what was recorded among participants in this group, but they cannot by themselves establish how outcomes would differ under an alternative strategy. The record does not report a separate control group, random assignment, or masking.

The registry describes one primary outcome measure, with a timeframe of 8 Months. Its definition is the percentage of patients completing the full dose of radiation therapy. The endpoint title additionally refers to safely tolerating and completing hormonal therapy and docetaxel, creating a difference between the broad wording of the title and the narrower measurement definition. The registry record does not report the study’s sample-size justification, detailed statistical analysis plan, or reasons for choosing this design.

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:

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 Percentage of Patients Who Can Safely Tolerate and Complete Adjuvant Hormonal Therapy, Radiation Therapy and Docetaxel After a Radical Prostatectomy, measured over 8 Months.

The primary endpoint is recorded as a percentage of participants and is defined as the percentage who complete the full dose of radiation therapy. The timeframe is 8 Months. This kind of endpoint expresses treatment completion as a proportion of the group being evaluated. In general, a completion measure can address whether a regimen was deliverable as planned, which is relevant in a study combining several therapies.

The endpoint title is broader than its definition: it refers to safely tolerating and completing hormonal therapy, radiation therapy, and docetaxel after radical prostatectomy, whereas the definition identifies completion of the full radiation dose. The registry record does not explain whether treatment tolerance or completion of hormonal therapy and docetaxel was captured elsewhere, or how those elements relate to the stated primary measure.

No numerical result for this endpoint is reported in the registry record. The number of participants included in its analysis and the handling of participants who did not complete treatment are also not reported in the registry record. Therefore, the endpoint’s value and its precision cannot be assessed from the posted results. The enrollment figure alone does not establish the denominator used for the primary endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies a percentage endpoint, a single-group design, and no listed analyses. It does not report a detailed statistical analysis plan. The concepts below are general explanations of how such information is commonly interpreted; they are not claims about methods used in this study unless specifically stated in the registry record.

What does a percentage endpoint represent?

In general, a percentage for a binary outcome is the number of participants meeting a stated condition divided by the number evaluated for that outcome, expressed as a percentage. For this study, the stated condition is completion of the full radiation dose. The numerator and denominator for that endpoint are not reported in the registry record, so the percentage cannot be reconstructed or independently interpreted. Enrollment is reported as 27, but the registry record does not state that all enrolled participants were included in the primary-endpoint analysis.

A clear endpoint definition is important because the same study may use different rules for treatment completion, tolerability, or safety. The registry’s primary endpoint title refers to safe tolerance and completion of radiation, hormonal therapy, and docetaxel. Its definition refers only to completing the full radiation dose. Without additional operational details, it is not possible to tell whether treatment interruptions, dose changes, discontinuation of one component, or other circumstances counted as endpoint failure.

Why does the design matter?

In general, a single-group study describes outcomes among participants receiving the studied intervention. It does not generate a randomized between-group treatment contrast. Outcomes may be influenced by characteristics of the participants, clinical decisions, and other factors that are not separated from the intervention by a concurrent control group. As a result, a descriptive percentage would answer how often the endpoint was observed in the analyzed group, not how much the treatment changed the chance of that outcome compared with an alternative.

The registry lists allocation as NA, masking as none, and the model as single group. These design features are consistent with the absence of a like-for-like control comparison. The record does not describe any adjusted comparison or other analysis that would change that basic interpretation.

What would uncertainty around a percentage mean?

In general, a confidence interval describes statistical uncertainty around an estimated quantity under a stated method and assumptions. For a binary percentage, the interval is influenced by the number of participants evaluated and the number meeting the endpoint. A narrower interval generally indicates greater statistical precision, while a wider interval indicates more uncertainty. A confidence interval is not a guarantee that the true value lies within its limits, and it does not address every source of bias or ambiguity in endpoint definition.

No primary-endpoint estimate or confidence interval is reported in the registry record. Consequently, there is no reported estimate whose precision can be evaluated. The safety counts have their own descriptive meaning and should not be treated as a confidence interval or as an estimate of the primary endpoint.

How should planning calculations be understood?

In general, sample-size calculations are planning tools that describe how many participants a study might need under specified assumptions about an outcome, effect, significance level, allocation, and analysis method. A planning calculation does not report what happened in the study. It is not observed power, and it cannot replace an outcome estimate with its uncertainty.

The registry record does not report the study’s own sample-size justification. Any planning illustration based on an observed effect would depend on that effect and on the assumptions used for the illustration; it would not demonstrate that the completed study had a particular probability of detecting a result. The posted information does not include a numerical primary-endpoint effect from which such an illustration could be interpreted.

The record states general assumptions for planning illustrations: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Those assumptions describe an illustration rather than this study’s single-group design. The stated two-arm allocation does not match the registry’s single-group model, and the registry record does not report a trial-specific calculation based on those assumptions. No participant-per-arm planning values are stated in the registry record.

What can safety summaries tell readers?

In general, adverse-event summaries count participants or events according to the definitions used in the record. These are distinct units: one participant may experience more than one event, and an event term may be reported for more than one participant. The registry summary identifies participants at risk and participants affected for serious and other adverse events, but it does not give detailed event-level timing or explain whether categories overlap. The listed percentages for serious terms should therefore be read as registry-reported descriptive values, not as evidence of causation or as a comparison between treatment groups.

Statistical interpretation depends on both the endpoint and its analysis population. Since the primary-endpoint denominator, endpoint result, missing-data rules, and analysis population are not reported in the registry record, readers cannot assess how those choices affected the reported result. No inferential test or model for the primary endpoint is listed.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("RT, Docetaxel, Hormonal Therapy")
n      <- c(27)
events <- c(7)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  RT, Docetaxel, Hormonal Therapy  27  7  25.9  11.1  46.3  13.2  44.7  13.2  44.9

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome measure and no analyses. It does not report a multiplicity strategy, such as how statistical interpretation would account for testing more than one outcome or making multiple comparisons. There is no comparison group in the design, and the record does not list inferential comparisons. It would be inappropriate to assume that a correction for multiple testing was used, or that multiplicity was irrelevant to every possible analysis.

Missing-data handling is not reported in the registry record. The record does not state how participants with incomplete endpoint information, treatment discontinuation, or missing follow-up were handled. It also does not report an analysis population for the primary endpoint. Although 27 participants were enrolled, the registry does not establish whether the endpoint denominator was all enrolled participants or a subset.

These omissions matter because a completion percentage depends on the definition of completion and the denominator used. If participants without an observed endpoint are excluded, counted as not completing treatment, or handled by another rule, the resulting percentage may differ. The registry record does not state which approach was used. It also does not report sensitivity analyses that might show whether conclusions change under alternative assumptions about missing outcomes.

The record does not report a prespecified statistical analysis plan, interim analyses, or rules for stopping or modifying the study. Those matters should be treated as unreported rather than inferred from the Phase I/II designation or from the enrollment figure. Without the endpoint result, analysis population, and missing-data rules, readers cannot evaluate the robustness of a primary-endpoint estimate.

12. 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 serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hypertension (3.7%), injection site reaction (3.7%), hyperglycemia (3.7%), chest pain (3.7%), cystitis (3.7%).

The registry lists 27 participants at risk for serious adverse events, with 3 participants affected, and 27 at risk for other adverse events, with 27 affected. It reports 0 deaths. These are descriptive safety counts for the single treatment group, not a comparison with another group. The record does not state whether all enrolled participants contributed the same duration of follow-up.

The listed serious adverse event terms are Hypertension, Injection site reaction, Hyperglycemia, Chest pain, and Cystitis, each reported as 3.7%. These percentages are registry-reported values. The record does not clarify whether a participant could contribute to more than one term, whether terms overlap, or the number of distinct events represented by each percentage. They should not be added together or treated as independent categories.

In general, adverse-event summaries describe events recorded under the study’s reporting definitions; they do not by themselves establish that treatment caused an event. The registry record does not report attribution, onset, duration, or detailed severity for the listed terms. The serious-event counts also do not indicate whether events led to treatment interruption or affected completion of the primary endpoint. The registry’s safety information therefore provides a limited descriptive account, not a comparative or causal assessment.

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

The registry record establishes that the study evaluated a combined postoperative regimen of radiation therapy, concurrent docetaxel, and hormonal therapy in a single group after radical prostatectomy and lymph node sampling. It records enrollment of 27 and identifies completion of the full radiation dose as the primary endpoint definition, with an 8 Months timeframe. The study is listed as completed.

Those details do not establish the proportion who completed the radiation dose, because no numerical primary-endpoint result is reported in the registry record. The endpoint title also refers to safe tolerance and completion of hormonal therapy and docetaxel, but its definition does not specify those treatment components. The record therefore does not support a quantified conclusion about completion of the entire combined regimen.

In general, a treatment-completion result would describe the observed experience of the participants included in the endpoint analysis. It would not, in a single-group study, show how completion compares with another regimen or what would have happened to the same participants under a different strategy. A numerical result would also need its denominator and uncertainty to support a precise interpretation. Those endpoint details are not reported in the registry record.

The safety summary reports serious and other adverse events and 0 deaths, but it does not provide a comparative reference group or enough detail to establish causal relationships. The record does not state whether events were judged related to treatment, how event timing was assessed, or whether adverse events affected treatment completion.

Thus, the posted information is useful for identifying the regimen, study structure, and recorded safety counts, but it does not provide the primary outcome value needed to judge the observed completion rate. It also cannot support a causal comparison or a broad conclusion about the regimen beyond the descriptive details recorded.

14. Why This Trial Matters Statistically

This study raises a useful statistical distinction between a treatment-completion question and a treatment-effect question. A completion endpoint can describe whether participants received a planned course, while a comparative treatment-effect question asks how outcomes differ between strategies. The registry lists a single-group study, so its design addresses the first kind of question more directly than the second.

Endpoint wording is also consequential. The primary endpoint title refers to safe tolerance and completion of radiation, hormonal therapy, and docetaxel, but the definition narrows the measure to completion of the full radiation dose. Such a difference can affect what counts as success, which participants are counted, and how readers interpret a percentage. The registry record does not clarify the relationship between these statements.

For statistical interpretation, a result is not just a percentage. Readers need to know the endpoint definition, the analysis denominator, how incomplete observations were treated, and how much uncertainty surrounds the estimate. The registry record does not report a numerical primary-endpoint result or these analysis details. This makes it impossible to assess the central outcome’s value and precision.

The safety summary illustrates another important distinction: reported adverse-event counts describe what was recorded, but do not establish attribution or comparative risk. With no separate control group, the registry cannot provide a randomized safety contrast. The record’s serious and other adverse-event counts remain descriptive information for the study group.

The statistical importance of the record lies in making these boundaries visible. It identifies a clinically specific regimen and a completion-oriented endpoint, while also leaving key outcome and analysis details unreported. Recognizing both what the design can address and what the registry does not report is essential to avoid interpreting enrollment, completion intent, or safety counts as evidence of an unreported primary result.

15. 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 immediate limitation for interpretation is the absence of a numerical primary-endpoint result in the registry record. Although the outcome is defined as the percentage completing the full radiation dose within 8 Months, the record does not report that percentage, its numerator, its denominator, or an uncertainty interval. The main endpoint therefore cannot be evaluated quantitatively.

The endpoint title and definition are not fully aligned. The title refers to safe tolerance and completion of radiation therapy, hormonal therapy, and docetaxel; the definition refers only to completion of the full radiation dose. The record does not explain how tolerance was defined or whether completion of the hormonal and chemotherapy components was part of the endpoint assessment.

The single-group design has no comparator, so it cannot estimate a randomized difference between treatment strategies. The registry record also does not report the sample-size justification, a detailed statistical analysis plan, analysis populations, missing-data procedures, or interim analyses. These are limitations of the information recorded; their absence does not establish what procedures may have been used outside the registry entry.

The safety summary is limited to participant counts and selected serious adverse event terms. The registry record does not provide event timing, attribution, overlap, follow-up duration, or the relationship between adverse events and treatment completion. Consequently, these counts cannot establish causation or a comparative safety profile.

Finally, the record’s listing of 27 enrolled participants does not establish that all 27 contributed to the primary endpoint analysis. Without the endpoint denominator and handling of incomplete information, the relationship between enrollment and the observed outcome cannot be assessed.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic Prostate Cancer — NCT00669162.
• Registry record last updated 2019-07-24; status last verified 2018-02.
• Results first posted 2019-07-24.
• 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.

19. Record Summary

NCT00669162 is a completed Phase I/II, single-group study sponsored by the University of Kansas Medical Center. The registry records 27 participants enrolled, no masking, and allocation as NA. The study start is 2012-08 and primary completion is 2016-08.

The intervention combines postoperative radiation therapy, concurrent weekly docetaxel, and hormonal therapy after radical prostatectomy and lymph node sampling. The listed primary outcome is the percentage completing the full radiation dose within 8 Months. Its title also refers to safe tolerance and completion of hormonal therapy and docetaxel, but the definition specifies radiation completion.

The registry record does not report a numerical primary-endpoint result or detailed analysis methods. Safety information lists 3 participants with serious adverse events among 27 at risk, 27 with other adverse events among 27 at risk, and 0 deaths. The record does not provide a comparator group or establish a causal interpretation of these events.