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 Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer (NCT00016913), a na phase 2 study. The primary outcome is Toxicity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00016913 |
| Phase | Phase 2 |
| Condition | Prostate Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 34 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Alliance for Clinical Trials in Oncology |
| Results posted | Yes |
2. Clinical Question
Population
Men with poor-prognosis localized prostate cancer were the intended population. The arm description specifies patients with localized high-risk prostate cancer. The registry reports 34 enrolled participants, while final analyses were performed on 27 eligible patients. Further eligibility details and participant characteristics are not reported in the registry record.
Intervention
The study evaluated neoadjuvant chemotherapy with paclitaxel, estramustine, and carboplatin, together with androgen ablation, before radiation therapy. The listed androgen-ablation drugs were leuprolide or goserelin acetate. The arm description reports four cycles over 16 weeks of weekly paclitaxel, estramustine on five days each week, and carboplatin on the first day of each cycle. The remaining regimen details are not reported in the registry record.
Comparator
There was no separate comparison group. The trial used a single-group design, and allocation was recorded as not applicable. Consequently, the study does not provide a randomized, like-for-like comparison against another treatment or a control group. Any interpretation is limited to outcomes observed among participants receiving the study regimen.
Primary question
The primary endpoint was toxicity: counts of acute grade 3 or greater cardiovascular, gastrointestinal, or genitourinary toxicities during treatment through 90 days or less after radiotherapy, with the same toxicity measures monitored after 90 days. The stated timeframe was 90 days and one year post treatment. The clinical question was whether this treatment sequence could be evaluated for these toxicities in the study population. The registry record does not report the primary endpoint’s result, so the number of participants experiencing these defined toxicities cannot be established from the posted result information.
3. Trial Design
This completed phase II trial, NCT00016913, investigated neoadjuvant paclitaxel, estramustine, and carboplatin with androgen ablation before radiation therapy in patients with poor-prognosis localized prostate cancer. The registry lists Prostate Cancer as the condition and the Alliance for Clinical Trials in Oncology as the sponsor. The study began in 2001-05, reached primary completion in 2007-07, and has completed status.
The design is single group, with allocation recorded as not applicable and no masking. Thus, participants were not assigned between randomized treatment arms, and the record does not define a concurrent control group. The enrolled population was 34. The primary endpoint description says final analyses were performed on all 27 eligible patients. The registry record does not explain the eligibility differences between the enrolled and analyzed populations.
The intervention combined chemotherapy, androgen ablation, and radiation therapy. The listed drugs were paclitaxel, estramustine, carboplatin, and leuprolide or goserelin acetate; radiation therapy was also listed. The arm description specifies four cycles over 16 weeks and gives some chemotherapy dosing details. Its remaining regimen text is incomplete in the registry record, so details beyond those stated cannot be characterized.
The primary outcome was toxicity, measured as events and defined around specified grade 3 or greater cardiovascular, gastrointestinal, or genitourinary toxicities. Time-to-prostate-specific-antigen failure and progression-free survival were listed as secondary outcomes. The registry record does not report their outcome estimates or analysis details. It also does not report a protocol-level statistical plan, sample-size justification, interim-analysis plan, or detailed follow-up procedures.
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: Of these 34 patients, 4 patients did not have radiotherapy, 2 patients were ineligible, and 1 case had limited follow-up data after radiotherapy. Final analyses were performed on 27 patients.
Overall Study
| Stage | Neo-Adj ChemoTx + Ablation Prior to RT |
|---|---|
| STARTED | 27 |
| COMPLETED | 27 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Final analyses were performed on all 27 eligible patients.
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.
| Characteristic | Unit | Neo-Adj ChemoTx + Ablation Prior to RT |
|---|---|---|
| Participants analysed | 27 | |
| Age, Continuous | years | 61 (52 to 75) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 27 |
| Region of Enrollment: United States | participants | 27 |
6. Primary Endpoint
The registry lists the primary outcome as Toxicity, measured over 90 days and 1 year post treatment.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled Toxicity and is measured in events. It concerns grade 3 or greater cardiovascular toxicity, including venous thrombosis, gastrointestinal toxicity, or genitourinary toxicity. Acute toxicity was defined over the period from treatment initiation through 90 days or less after completion of radiotherapy. The description says the same toxicity measures were monitored after 90 days; the stated endpoint timeframe is 90 days and one year post treatment.
Such an endpoint is used to describe clinically important treatment-related harms within defined organ-system categories and observation periods. Counting events can indicate the recorded burden of toxicity, but an event count is not necessarily the same as a count of people: one participant may experience more than one event unless the reporting method specifies otherwise. The registry record does not explain whether its intended count was events, affected participants, or both, nor does it provide the primary endpoint value.
The registry identifies 27 eligible patients in the final analyses, but it does not state the number among them with the defined toxicities. The separate adverse-event figures do not by themselves answer this primary endpoint question: their category labels and reporting scope are not shown to match the primary endpoint’s specific grade, organ systems, and timing. The endpoint result is therefore not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a completed, single-group phase II study and identifies toxicity as its primary outcome. The population for final analyses is reported as all 27 eligible patients. However, the numerical result for the defined toxicity endpoint is not reported in the registry record. Without that result, the frequency of the specified acute or later toxicities cannot be summarized, and no estimate of its precision can be assessed.
The record lists time to prostate-specific antigen failure and progression-free survival as secondary outcomes, but it does not report estimates, event counts, follow-up summaries, or comparative analyses for them. It also lists no analyses. This means the posted record does not offer the information needed to evaluate the magnitude or precision of those time-to-event outcomes. It does not establish that analyses were never conducted; it establishes only that analysis results are not reported in the registry record.
The posted safety counts are 0 serious adverse events among 29 at risk and 29 other adverse events among 29 at risk. These counts have a different reported denominator from the 27 eligible patients in the final efficacy analyses. The record does not explain the distinction or show that the safety categories correspond to the primary endpoint definition. In particular, the count of other adverse events cannot be treated as a count of the specified grade 3 or greater toxicities.
Because there is no control group, the study cannot estimate a treatment contrast against another regimen. Descriptive results, if fully reported, would characterize outcomes among participants receiving the combined treatment sequence; they would not isolate the contribution of chemotherapy, androgen ablation, or radiation therapy. The absence of a randomized comparison also limits conclusions about whether observed outcomes differ from what would occur under another approach.
General statistical interpretation: an estimate describes an observed quantity in the study population, while a confidence interval describes uncertainty around that estimate under the analysis assumptions. Neither can be interpreted when the relevant estimate and interval are absent. A p-value, if reported, would address a specified statistical hypothesis rather than prove that an intervention is beneficial or harmful. No p-values or confidence intervals for the trial outcomes are reported in the registry record.
The enrollment count, final eligible analysis population, and safety denominator should be kept distinct rather than combined. Their differences are not explained in the registry record. As a result, the most defensible reading is limited: the study’s design and endpoint definitions are described, but the posted information does not provide the primary toxicity result or the secondary outcome estimates needed for a fuller statistical assessment.
9. Statistical Methods Explained
What does a single-group design estimate?
The trial is recorded as single group, with no masking and allocation not applicable. In general, a single-group study can describe outcomes observed among participants receiving a regimen. It does not create a concurrent randomized contrast, so it cannot separate the effect of the regimen from other influences, such as the participants’ underlying prognosis, care received outside the study, or changes over time. These are general design considerations, not additional findings about this trial.
The registry does not report a comparative statistical analysis. A single-group design can still be informative for describing toxicity or outcome patterns, provided the outcome definitions, analysis population, follow-up, and results are reported clearly. Here, the primary endpoint value and secondary outcome estimates are not reported in the registry record.
How should event counts be understood?
The primary outcome is described as a number of toxicity events. In general, an event count summarizes occurrences over a defined observation period. Depending on the reporting rules, counts may include repeated events in one person; a participant count instead records whether each person had at least one event. Those quantities answer different questions. The registry record does not specify how repeated toxicities were handled or provide the primary count, so neither the event burden nor the number of affected eligible participants can be inferred.
The toxicity definition restricts the endpoint to grade 3 or greater cardiovascular, gastrointestinal, or genitourinary events, with cardiovascular toxicity including venous thrombosis. The specified timing distinguishes acute toxicity through 90 days or less after radiotherapy from monitoring after 90 days. In general, clear timing rules matter because they define which events belong in each outcome window. The registry gives a stated timeframe of 90 days and one year post treatment, but does not provide detailed results within those periods.
What do the planning assumptions mean?
The record includes assumptions for a planning illustration based on the observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. For time-to-event outcomes, the illustration is based on total events using the Schoenfeld method; for other outcomes, it describes participants per arm.
These are planning assumptions, not a description of the trial’s single-group design. The stated equal allocation between two arms does not match the recorded design, which has no randomized comparison. No numerical planning estimates are reported in the registry record. In general, sample-size calculations are prospective planning illustrations and do not measure the probability that a completed study has found a real effect. They should not be interpreted as observed power or as evidence that a result is statistically significant.
What can be said about precision?
General explanation: a confidence interval gives a range of values compatible with the observed data and the statistical model at a stated confidence level. Its width reflects precision; small samples or sparse events can produce substantial uncertainty. The registry record does not report confidence intervals for the primary endpoint or secondary outcomes. Since the endpoint result is also not reported, precision cannot be assessed from the posted results.
For time-to-event outcomes, methods often account for when events occur and for participants who have not experienced an event by the end of observation. This requires information about event timing and censoring, among other details. The registry lists time to prostate-specific antigen failure and progression-free survival, but does not report event counts, estimates, analysis methods, or follow-up information. No specific survival-analysis method can therefore be attributed to the trial from this record.
What analyses are listed?
No analyses are listed in the registry record. It does not report the statistical test or model for the toxicity endpoint, methods for handling repeated events, confidence-interval procedures, covariate adjustment, or the analysis methods for the secondary outcomes. The sample-size assumptions do not fill in these missing details: they describe a planning illustration, not the trial’s complete analysis plan. In general, analysis methods should be interpreted alongside the outcome definition, population, missing-data handling, and any deviations from the planned approach. Those details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome, Toxicity, and two secondary outcomes: time to prostate-specific antigen failure and progression-free survival. It does not report a multiplicity strategy, such as how interpretation would account for testing more than one outcome or multiple time points. No statistical analyses are listed, and no outcome estimates or p-values are reported. Whether multiplicity was addressed in a protocol or another analysis plan is not reported in the registry record.
The primary endpoint description refers to acute toxicities and monitoring after 90 days, while its stated timeframe is 90 days and one year post treatment. The record does not give a detailed schedule of assessments or separate results for those periods. It also does not explain how multiple events in one participant were counted.
Final analyses were performed on all 27 eligible patients, while the registry reports 34 enrolled participants. The reason for this distinction and the disposition of participants not included in the final eligible population are not reported in the registry record. Safety counts use 29 participants at risk. The relationship between that denominator and the enrolled or eligible analysis populations is also not reported.
Missing-data rules, the amount of missing outcome information, and any sensitivity analyses are not reported in the registry record. General statistical context: exclusions and missing follow-up can affect how representative an analysis is of the enrolled population. Without the reasons for exclusions and a description of missingness, the direction or size of any resulting bias cannot be determined. The registry record also does not report whether analyses followed an intention-to-treat principle or another defined population rule.
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 |
|---|---|---|---|
| Neo-Adj ChemoTx + Ablation Prior to RT | 0 | 29 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Neo-Adj ChemoTx + Ablation Prior to RT | 29 of 29 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Neo-Adj ChemoTx + Ablation Prior to RT |
|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | 27 of 29 |
| Urinary frequency | Renal and urinary disorders | 26 of 29 |
| Fatigue | General disorders | 25 of 29 |
| Blood glucose increased | Metabolism and nutrition disorders | 23 of 29 |
| Constipation | Gastrointestinal disorders | 18 of 29 |
| Leukocyte count decreased | Investigations | 18 of 29 |
| Peripheral sensory neuropathy | Nervous system disorders | 18 of 29 |
| Diarrhea | Gastrointestinal disorders | 17 of 29 |
| Nausea | Gastrointestinal disorders | 17 of 29 |
| INR increased | Investigations | 15 of 29 |
The registry reports 0 serious adverse events among 29 participants at risk and 29 other adverse events among 29 participants at risk. No serious adverse-event terms are listed. These are safety-category counts as reported; they are not the primary endpoint result.
The primary toxicity outcome has a narrower definition: grade 3 or greater cardiovascular, gastrointestinal, or genitourinary toxicity, evaluated over specified periods. The registry does not establish that the serious and other adverse-event categories use the same severity threshold, event definitions, or time windows. The count of 29 other adverse events therefore should not be read as 29 cases of the primary endpoint. Likewise, 0 serious adverse events does not establish that there were no events meeting the primary toxicity definition.
The safety denominator is 29, while the final eligible analysis population is 27 and enrollment is 34. The registry record does not explain why these populations differ, whether the safety counts refer to people with at least one event or to event totals, or whether all safety observations were complete. These counts describe the posted safety record but do not resolve the missing primary toxicity result.
12. What the Result Does, and Does Not, Mean
The study record documents a phase II investigation of chemotherapy and androgen ablation before radiation therapy in patients with poor-prognosis localized prostate cancer. It identifies toxicity as the primary outcome and provides the categories and observation periods used in its definition. It also records that the final analyses included 27 eligible patients and lists prostate-specific antigen failure and progression-free survival as secondary outcomes.
However, the numerical result for the primary toxicity endpoint is not reported in the registry record. Nor are estimates for the secondary outcomes. As a result, the posted information cannot quantify the observed frequency of the defined toxicities, characterize the time-to-event outcomes, or show how precise any estimates were. The serious and other adverse-event counts are not substitutes for those missing endpoint results.
The trial’s single-group design also limits what any descriptive result could establish. Without a concurrent control group, outcomes cannot be compared on a randomized basis with another treatment strategy. The design cannot isolate the effect of any one component of the combined regimen. These are limits on causal interpretation, not evidence for or against a treatment effect.
General statistical context: a study can report an observed outcome without establishing that the treatment caused it, and uncertainty remains even when an estimate is available. Interpretation depends on the design, the completeness of follow-up, the analysis population, and the precision of the estimate. Several of those elements are not reported in the registry record, and the main numerical outcomes are absent.
Accordingly, the record supports a description of the trial’s intent, design, endpoint definitions, enrollment, and limited safety counts. It does not support a conclusion about the magnitude of toxicity, the clinical outcomes, or comparative effects. The absence of a reported result should be understood as a limitation of the posted record, not as a result indicating no events or no effect.
13. Why This Trial Matters Statistically
This trial is statistically notable for the gap between a defined primary endpoint and the outcome information available in the registry. Toxicity is named as the primary measure, with specified organ systems, severity, and observation periods, but its numerical result is not reported. Without the endpoint value, readers cannot assess the event frequency or its precision, even though the analysis population is identified as 27 eligible patients.
The study also illustrates why design and estimand matter. A single-group study can describe what happened to participants receiving a combined regimen, but it does not provide a randomized comparison. Any observed outcome would remain a description of that group rather than a direct estimate of how outcomes differ under another treatment. Since the regimen combines chemotherapy, androgen ablation, and radiation therapy, the design cannot isolate the contribution of an individual component.
The registry contains several denominators: 34 enrolled, 27 eligible for final analyses, and 29 at risk for the reported safety counts. These figures refer to distinct reported populations, and their relationship is not explained. Keeping them separate is essential for avoiding misleading summaries of who contributed to each outcome.
Finally, the record lists secondary time-to-event outcomes but gives no estimates or analysis details. This makes the study a useful reminder that outcome names alone do not permit statistical interpretation. Definitions, analysis populations, event counts, follow-up, and uncertainty measures are all needed to understand what the results show. In this case, the design and intended measures are described more fully than the posted outcome findings.
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.
A central limitation is that the primary endpoint result is not reported in the registry record. The outcome definition and timeframe are available, but there is no count of the defined grade 3 or greater toxicities or estimate of uncertainty. The record likewise lists secondary outcomes without reporting their results.
The single-group design has no concurrent control arm. It therefore cannot provide a randomized comparison, and outcomes cannot be attributed uniquely to the combined regimen or to any one of its components. Allocation is recorded as not applicable and masking as none.
The populations differ across the reported counts: enrollment was 34, final analyses included 27 eligible patients, and the safety figures use 29 participants at risk. Reasons for these differences, participant disposition, and the relationship among analysis populations are not reported in the registry record. Missing-data rules and the completeness of outcome follow-up are also not reported.
The arm description contains only partial regimen details. The registry identifies some drugs and schedule information, but the remaining regimen text is incomplete. Detailed protocol procedures, eligibility criteria, assessment schedules, and statistical methods are not reported in the registry record. The planning assumptions describe a two-arm illustration, whereas the recorded trial design is single group; no numerical planning estimates are reported. Those assumptions should not be read as the study’s own design or as evidence about the observed results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer — NCT00016913.
- Registry record last updated 2016-07-06; status last verified 2016-07.
- Results first posted 2016-01-29.
- 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
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT00016913 is a completed phase II, single-group study sponsored by the Alliance for Clinical Trials in Oncology. It evaluated paclitaxel, estramustine, and carboplatin with androgen ablation before radiation therapy for poor-prognosis localized prostate cancer. Enrollment was 34; final analyses were performed on 27 eligible patients.
The primary endpoint was toxicity, defined around grade 3 or greater cardiovascular, gastrointestinal, or genitourinary events over stated treatment-related periods. Time to prostate-specific antigen failure and progression-free survival were listed as secondary outcomes. The registry reports 0 serious adverse events among 29 at risk and 29 other adverse events among 29 at risk.
The primary toxicity result and secondary outcome estimates are not reported in the registry record. The record does not list statistical analyses, explain differences among the reported populations, or provide missing-data methods. With no control group, the study offers no randomized treatment comparison.