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 Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer (NCT00321698), a non-randomized phase 1, phase 2 study. The primary outcome is Maximum Tolerated Dose (MTD).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00321698 |
| Phase | Phase 1, Phase 2 |
| Condition | Prostate Cancer |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 25 |
| Arms in the primary outcome | n/a |
| Lead sponsor | OHSU Knight Cancer Institute |
| Results posted | Yes |
2. Clinical Question
Population
Men with high-risk localized prostate cancer who were undergoing surgery. The registry describes the primary outcome analysis as including subjects from all 4 phase I groups, including subjects who received radiation only.
Intervention
Preoperative external-beam radiation with docetaxel at escalating doses. The registry describes a fixed radiation dose of 45 Gy and docetaxel starting at 10 mg/m2, with escalation in increments of 10 mg/m2 to a pre-planned ceiling of 30 mg/m2.
Comparator
This was a non-randomized, single-group study with no masking. Phase I included a radiation-only group and groups receiving docetaxel with radiation, but these were not randomized, like-for-like comparison groups.
Primary question
What maximum tolerated dose of docetaxel could be given with radiation, under the study’s dose-limiting toxicity rules? The registry also describes the broader phase I/II purpose as examining side effects, dose, and treatment activity before surgery. It does not report the observed maximum tolerated dose.
The clinical question is therefore primarily about dose and tolerability, rather than a randomized estimate of treatment benefit. The registry lists prostate-specific antigen response, safety, clinical response, surgical margin status, quality of life, urinary symptoms, and clinical progression-free rate among the secondary outcomes. Those listed outcomes do not establish that results for them were reported. The registry record lists 25 enrolled participants and a terminated status. It does not report the reason for termination.
3. Trial Design
This was a phase I/II, non-randomized, unmasked study with a single-group model. The registry lists 25 participants as enrolled. The study began on 2006-04-21, had a primary completion date of 2009-10-01, and is marked terminated. The reason for termination is not reported in the registry record.
The treatment plan combined external-beam radiation with escalating docetaxel doses. Radiation was fixed at 45 Gy, delivered as 1.8 Gy fractions, 5 per week for 5 weeks (25 fractions). The phase I description includes a radiation-only group and docetaxel groups at 10 mg/m2, 20 mg/m2, and 30 mg/m2, given weekly for 5 weeks starting on the first day of radiation. The phase II description specifies docetaxel 30 mg/m2 weekly for 5 weeks, in the circumstance described as no phase I dose-limiting toxicities.
The phase I plan used observed dose-limiting toxicities to guide escalation. The registry defines a dose-limiting toxicity as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity attributable to chemoirradiation. It describes rules for continuing enrollment at a dose or stopping escalation, and defines the maximum tolerated dose using the number of dose-limiting toxicities among up to 6 patients at a dose. These are protocol descriptions, not evidence that a particular dose met the rule.
The record does not describe a randomized comparison or a masked assessment. Although a radiation-only group appears in the phase I description, group assignment was non-randomized. Differences between these groups therefore cannot be interpreted as if they arose from randomized allocation.
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: Our 1 screen failure was excluded as a result of having a different type of cancer, other than non-melanoma skin cancer, within the past 5 years.
Phase I, Rad Only & Dose 1-3
| Stage | Phase I, Radiation Only | Phase I, Dose 1 | Phase I, Dose 2 | Phase I, Dose 3 | Phase II, MTD Dose |
|---|---|---|---|---|---|
| STARTED | 3 | 3 | 3 | 3 | 0 |
| COMPLETED | 3 | 3 | 3 | 3 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Phase II, MTD Dose
| Stage | Phase I, Radiation Only | Phase I, Dose 1 | Phase I, Dose 2 | Phase I, Dose 3 | Phase II, MTD Dose |
|---|---|---|---|---|---|
| STARTED | 0 | 0 | 0 | 0 | 13 |
| COMPLETED | 0 | 0 | 0 | 0 | 13 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Outcome analysis includes the subjects from all 4 phase I groups, inclusive of subjects who only received radiation, as all subjects across all phases received the same radiation dosage. Phase I, group 1 subjects were included in case MTD was zero.
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 | Phase I, Radiation Only | Phase I, Dose 1 | Phase I, Dose 2 | Phase I, Dose 3 | Phase II, MTD Dose | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 3 | 3 | 3 | 3 | 13 | 25 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 2 | 2 | 3 | 11 | 20 |
| Age, Categorical: >=65 years | Participants | 1 | 1 | 1 | 0 | 2 | 5 |
| Age, Continuous | years | 66.67 (SD 8.14) | 62.67 (SD 7.64) | 66.33 (SD 4.93) | 58.00 (SD 6.56) | 60.54 (SD 4.58) | 61.92 (SD 5.89) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 3 | 3 | 3 | 3 | 13 | 25 |
| Region of Enrollment: United States | participants | 3 | 3 | 3 | 3 | 13 | 25 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Tolerated Dose (MTD), measured over 5 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | mg/m^2 |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the maximum tolerated dose (MTD) of docetaxel given with radiation, expressed in mg/m^2. The registry specifies a timeframe of 5 weeks. This is a dose-finding endpoint: the planned escalation varies the docetaxel dose while radiation remains fixed at 45 Gy.
The registry defines the MTD using dose-limiting toxicity (DLT). A DLT is described as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity attributable to chemoirradiation. The stated decision rules use the number of DLTs observed at each dose to determine whether escalation continues or stops. Under the description, a dose with no more than 1 DLT among up to 6 patients can meet the stated MTD criterion, subject to the detailed escalation rules.
In general, a dose-finding endpoint is used to identify a tolerability boundary for subsequent study, rather than to estimate comparative efficacy. The MTD is not itself a measure of tumor response, quality of life, or survival. Here, the registry’s primary endpoint field gives the definition and planned assessment, but an observed MTD value is not reported in the registry record. The record also does not report the number of DLTs by dose or a completed dose-escalation result. Consequently, the endpoint’s plan can be described, but its result cannot be reconstructed from the posted information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a dose-finding study, not a randomized test of whether adding docetaxel to radiation improves outcomes. Its primary endpoint is the maximum tolerated dose, and the registry explains how dose-limiting toxicities were intended to guide escalation. However, it does not report the primary endpoint result. In particular, there is no posted MTD value or dose-by-dose DLT summary in the record. The planned ceiling of 30 mg/m2 and the phase II dose description are protocol information, not confirmation of the MTD observed in the study.
The record lists 25 enrolled participants and a terminated status. Enrollment alone does not show how many participants were evaluable for the primary endpoint, completed treatment, or contributed to each outcome. Those details are not reported in the registry record. The reason for termination is also not reported. Without these details and the endpoint result, the posted information does not establish how the escalation rules played out or how precisely any dose estimate was determined.
The registry lists 8 outcome measures, including the primary MTD endpoint and secondary outcomes covering prostate-specific antigen response, safety, clinical response, surgical margins, quality of life, urinary symptoms, and clinical progression-free rate. A list of planned outcomes is not a report of their observed results. Apart from the posted adverse-event figures, numerical outcome results for these measures are not reported in the registry record. No inferential analyses are listed.
The adverse-event section gives serious adverse event counts for the displayed groups. Those counts describe the posted safety data but do not replace the DLT-by-dose information needed to interpret the primary endpoint. The record also lists selected serious adverse event terms with percentages. The interpretation of those percentages is limited because the registry entry does not explain the calculation details alongside the list.
In general, estimates from small, non-randomized cohorts are descriptive and can be imprecise. A comparison across groups can also be affected by how participants entered each group and by differences in who was assessed. Since the record does not report random allocation, group-level differences should not be attributed to treatment alone. The data shown can be read as a registry account of the design and selected safety counts, but not as a complete efficacy or dose-finding analysis.
9. Statistical Methods Explained
The posted design combines dose escalation with a subsequent phase II description. The methods below explain the statistical ideas relevant to interpreting that design; general explanations are identified as such. The registry record does not report a complete statistical analysis plan or the observed primary endpoint result.
What does dose escalation estimate?
The primary endpoint is the maximum tolerated dose of docetaxel with fixed-dose radiation. In general, a dose-escalation design uses observed toxicities at successive dose levels to decide whether to continue escalation, enroll more participants at a dose, or stop. The registry describes starting docetaxel at 10 mg/m2 and escalating by 10 mg/m2 up to a pre-planned ceiling of 30 mg/m2. It also states that the MTD is a dose associated with no more than 1 DLT up to 6 patients, with additional rules depending on how many participants have DLTs. These are the planned rules. The observed sequence of decisions and the resulting MTD are not reported in the registry record.
What does a DLT rule capture?
The registry defines a DLT by toxicity grade and attribution to chemoirradiation: clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity. In general, a DLT definition makes the dose-finding decision more reproducible by specifying which events count. It also means the endpoint depends on assessment, grading, timing, and attribution. The registry record does not report participant-level DLT data, the number of DLTs at each dose, or how many participants were evaluable for this endpoint. The separate serious adverse event counts should not be treated as a substitute for DLT counts, because the registry does not equate the two definitions.
How should the study structure be read?
The study is marked non-randomized and single-group, with no masking. Phase I includes a radiation-only group and groups receiving docetaxel with radiation. The phase II description specifies docetaxel 30 mg/m2 with radiation in the circumstance described as no phase I dose-limiting toxicities. A radiation-only group does not make the study randomized: participants were not assigned at random according to the registry. In general, randomized allocation helps balance both measured and unmeasured factors between comparison groups. Without it, observed differences between cohorts can reflect differences in who entered each group, treatment timing, or other factors as well as treatment. The registry does not report a causal comparison analysis.
What do uncertainty summaries mean?
In general, a confidence interval describes a range of values compatible with an estimate under the analysis assumptions. Wider intervals indicate less precision; narrower intervals indicate greater precision. The registry record does not report a confidence interval for the MTD or for the listed secondary outcomes. A missing interval cannot be inferred from the enrollment total or from the adverse-event counts alone.
In general, statistical tests and p-values address how compatible observed data are with a specified null model, conditional on the model and analysis assumptions. They do not measure the probability that a treatment works, and they do not establish clinical importance. No inferential analyses are listed in this registry record, so there is no posted p-value to interpret. A failure to report a test is not evidence that a result was statistically significant or not significant.
What do the safety counts contribute?
The adverse-event display reports, for each listed group, participants at risk and participants affected by serious adverse events, as well as a separate count for other adverse events. These are descriptive counts. In general, such counts can identify the frequency of recorded events in the displayed cohorts, but they do not by themselves establish whether events were caused by treatment or whether one regimen is safer than another. Cohort sizes, follow-up, ascertainment, and event definitions matter. The registry gives no deaths count for these groups, and death counts are not reported in the registry record.
How should planning illustrations be understood?
Any sample-size illustrations displayed with the page are planning scenarios based on the posted effect and specified assumptions, rather than evidence of the trial’s original design. In general, a power calculation estimates the sample size needed to detect an assumed effect under an analysis model. It is not observed power and does not demonstrate that an effect was detected. The registry record does not report the trial’s sample-size justification or its own prospective power calculation. The presence of an illustration should therefore not be read as the study’s original enrollment rationale.
Over-dispersion is a general concern when count data vary more than a chosen statistical model expects; accounting for it can affect uncertainty estimates. The posted record does not report an over-dispersion analysis, and no such method should be presumed. More broadly, the registry does not report details of a statistical model, missing-data handling, or adjustment for multiple outcomes. These absences limit methodological reconstruction and are not evidence that a particular method was or was not used outside the registry entry.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures: the primary MTD endpoint and several secondary measures covering prostate-specific antigen response, long-term safety, clinical response, surgical margin status, health-related quality of life, urinary symptoms, and clinical progression-free rate. It does not report a multiplicity strategy for interpreting results across these outcomes. In general, examining multiple outcomes can increase the chance of at least one apparently unusual result when each is considered separately. Adjustment methods or a prespecified hierarchy can address that issue, but the registry record does not state whether either was used.
The registry record does not list inferential analyses. It does not report a statistical analysis plan, a hierarchy for secondary endpoints, or endpoint-specific estimates and uncertainty intervals for the outcomes listed. No conclusion about statistical significance across the outcome set can be drawn from the outcome names alone.
Missing-data methods and analysis populations are also not reported in the registry record. The primary endpoint description says that the outcome analysis includes subjects from all 4 phase I groups, including subjects who received radiation only, because subjects across all phases received the same radiation dosage; it also says phase I group 1 subjects were included in case MTD was zero. This describes the stated primary outcome population, but does not provide participant flow, endpoint evaluability, exclusions, or missingness for each outcome. The registry lists 25 enrolled participants, but does not explain how many contributed to each analysis.
In general, missing outcomes can affect both the estimate and its uncertainty, particularly when the reasons for missingness relate to treatment or outcome. Without counts and reasons for missing data, or a stated analysis approach, the impact cannot be assessed from 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 |
|---|---|---|---|
| Phase I, Radiation Only | 0 | 3 | 0.0% |
| Phase I, Dose 1 | 3 | 3 | 100.0% |
| Phase I, Dose 2 | 3 | 3 | 100.0% |
| Phase I, Dose 3 | 3 | 3 | 100.0% |
| Phase II, MTD Dose | 8 | 13 | 61.5% |
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 |
|---|---|
| Phase I, Radiation Only | 0 of 3 |
| Phase I, Dose 1 | 0 of 3 |
| Phase I, Dose 2 | 0 of 3 |
| Phase I, Dose 3 | 0 of 3 |
| Phase II, MTD Dose | 0 of 13 |
Most frequent serious adverse event terms
| Event term | Organ system | Phase I, Radiation Only | Phase I, Dose 1 | Phase I, Dose 2 | Phase I, Dose 3 | Phase II, MTD Dose |
|---|---|---|---|---|---|---|
| Lymphapenia | Blood and lymphatic system disorders | 0 of 3 | 0 of 3 | 1 of 3 | 1 of 3 | 5 of 13 |
| Hyperglycemia | Metabolism and nutrition disorders | 0 of 3 | 2 of 3 | 0 of 3 | 1 of 3 | 1 of 13 |
| Hypophosphatemia | Metabolism and nutrition disorders | 0 of 3 | 0 of 3 | 0 of 3 | 0 of 3 | 2 of 13 |
| Hemoglobin (L) | Blood and lymphatic system disorders | 0 of 3 | 1 of 3 | 0 of 3 | 1 of 3 | 0 of 13 |
| Difficulty with ADLs | General disorders | 0 of 3 | 0 of 3 | 1 of 3 | 0 of 3 | 0 of 13 |
| Pain | Surgical and medical procedures | 0 of 3 | 0 of 3 | 1 of 3 | 0 of 3 | 0 of 13 |
| Hypokalemia | Blood and lymphatic system disorders | 0 of 3 | 0 of 3 | 0 of 3 | 0 of 3 | 0 of 13 |
| Hyponatremia | Blood and lymphatic system disorders | 0 of 3 | 0 of 3 | 0 of 3 | 0 of 3 | 0 of 13 |
Serious events with the highest arm-level rate: hyperglycemia (66.7%), lymphapenia (38.5%), difficulty with adls (33.3%), hemoglobin (l) (33.3%), pain (33.3%).
The adverse-event display reports serious adverse events by study group. It lists 0 of 3 participants affected in Phase I, Radiation Only; 3 of 3 in Phase I, Dose 1; 3 of 3 in Phase I, Dose 2; 3 of 3 in Phase I, Dose 3; and 8 of 13 in Phase II, MTD Dose. The separate count for other adverse events is 0 in each displayed group. These figures are counts within the registry’s group listings, not estimates from a randomized comparison.
The registry also lists serious adverse event terms and percentages: Hyperglycemia, 66.7%; Lymphapenia, 38.5%; Difficulty with ADLs, 33.3%; Hemoglobin (L), 33.3%; Pain, 33.3%; and Hypophosphatemia, 15.4%. The record does not give the calculation details for these percentages alongside the term list. They should not be added together or treated as mutually exclusive categories. A participant may contribute to more than one event term.
In general, adverse-event summaries describe recorded events in the displayed observation groups. They do not on their own establish causation, comparative risk, or the relationship between an event and the protocol’s DLT definition. The registry does not report deaths for these groups; death counts are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record supports a description of the study’s question and planned dose-finding rules. It documents a phase I/II, non-randomized study of radiation with escalating docetaxel, with an MTD endpoint defined through dose-limiting toxicities. It also posts serious adverse event counts for the listed groups and selected event terms with percentages. These are the results that can be described from the record.
It does not report an observed MTD, dose-specific DLT counts, or numerical results for the listed secondary outcomes. The phase II dose description and the planned ceiling of 30 mg/m2 are not substitutes for an observed endpoint result. The terminated status does not explain why the study stopped, since the reason is not reported in the registry record. Enrollment of 25 participants does not establish how many completed treatment or were included in each outcome analysis.
This study also does not provide a randomized comparison of radiation alone with radiation plus docetaxel. Its non-randomized design means that any differences among the displayed cohorts could be influenced by group composition and other factors. The registry record does not report an adjusted comparison or inferential analysis that would address these concerns. The posted safety figures should therefore be read descriptively, not as proof that one dose or regimen causes more or fewer events.
In general, absence of a reported result is not evidence of no effect, no toxicity, or no difference. It means the registry entry does not provide enough information to make that assessment. Likewise, planning descriptions are not observed outcomes, and a sample-size illustration is not observed power. The scope of interpretation should remain limited to the design and posted data rather than extending to unreported efficacy or comparative safety claims.
13. Why This Trial Matters Statistically
This record is statistically instructive because its primary question is a dose-finding question, not a conventional comparison of treatment outcomes. The MTD depends on a defined toxicity rule and the sequence of observed events as doses are escalated. The registry explains the rule, but does not report the DLT counts or resulting MTD. That separation between a protocol definition and an observed result is essential when reading registry entries.
The study also illustrates why a treatment group label does not necessarily imply a valid control comparison. Although the phase I description includes radiation only and docetaxel-plus-radiation groups, the allocation is non-randomized. In general, randomization helps make groups comparable at baseline; without it, differences can reflect participant selection as well as treatment. The design can still provide descriptive safety information, but it does not support interpreting group differences as randomized treatment effects.
Another important issue is the distinction between serious adverse events and DLTs. The record displays serious adverse event counts, while the primary endpoint uses a specific DLT definition tied to grade and attribution. These concepts may overlap, but the registry does not state that they are interchangeable. Treating the posted serious-event figures as if they were the primary endpoint would conflate different measures.
Finally, a registry entry may describe many planned outcomes without reporting a full analysis for each. Here, the registry lists 8 outcomes, but does not list inferential analyses or report an observed MTD. This makes transparent reporting of outcome definitions, analysis populations, missing data, and uncertainty particularly important for readers assessing what the posted record can support.
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 registry record has important gaps for interpreting the study’s primary question. Although it describes the MTD definition and escalation rules, it does not report the observed MTD, dose-specific DLT counts, or the number of participants evaluable at each dose. It also does not report the reason for termination. These omissions prevent a reader from assessing how the planned dose-finding process concluded.
The design was non-randomized and unmasked. The phase I radiation-only group is not a randomized control group, so any comparisons across the listed groups are vulnerable to differences in participant selection and other factors. The registry does not report an adjusted comparative analysis. It also does not provide enough participant-flow information to connect the total enrollment with completion, endpoint evaluability, or inclusion in each secondary outcome.
While the record lists 8 outcomes, it does not report a multiplicity approach, a detailed statistical analysis plan, missing-data methods, or uncertainty intervals for the outcomes. Numerical results for the listed secondary outcomes are not reported in the registry record. The serious adverse event figures are useful as descriptive counts, but the record does not provide death counts or clarify the percentage calculation details accompanying the selected event terms.
These limitations are specific to what the registry record documents. They do not establish that analyses or additional information were absent elsewhere; they mean that those details are not reported in the registry record and cannot be assessed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Radiation Therapy and Docetaxel in Treating Patients Who Are Undergoing Surgery for Localized Prostate Cancer — NCT00321698.
- Registry record last updated 2024-08-29; status last verified 2024-08.
- Results first posted 2016-12-30.
- 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.
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18. Record Summary
The registry describes a phase I/II study of preoperative radiation and docetaxel for high-risk localized prostate cancer. It lists a non-randomized allocation, no masking, a single-group model, 25 enrolled participants, and a terminated status. The reason for termination is not reported in the registry record.
The primary endpoint is the maximum tolerated dose of docetaxel with fixed-dose radiation, assessed over 5 weeks. The registry defines dose-limiting toxicity and describes dose-escalation rules, but does not report the observed MTD or dose-specific DLT results. The record lists 8 outcome measures and includes serious adverse event counts for the displayed groups, but does not list inferential analyses.
Accordingly, the record supports describing the design, endpoint definition, and posted safety counts. It does not support a complete interpretation of the dose-finding result or comparative efficacy.