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 Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer (NCT02274779), a na phase 2 study. The primary outcome is Median Relapse-Free Survival Time (Biochemical or Clinical).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02274779 |
| Phase | Phase 2 |
| Condition | Prostate Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 74 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Institut Cancerologie de l'Ouest |
| Results posted | Yes |
2. Clinical Question
Population
People with prostate cancer and a limited number of metastases at relapse were the population of interest. The brief summary describes eligibility context as 1-5 oligometastases; it does not report further participant characteristics or a detailed eligibility definition.
Intervention
The study evaluated salvage radiotherapy combined with hormonotherapy. The intervention listing names ELIGARD, and the arm description identifies high-dose IMRT with ELIGARD. The registry summary describes irradiation directed at lesions detected by PET-CT alongside LH-RH agonists.
Comparator
No separate comparator group is listed. The study model is single group, and allocation is recorded as NA. Therefore, the registry record does not describe a randomized comparison with another treatment or with no treatment.
Primary question
The primary outcome was median time to biochemical or clinical relapse, measured from treatment initiation and expressed in months. The registry record gives the outcome definition and a 2 years timeframe, but does not report the median estimate or its 95% confidence interval.
The clinical question is whether a combined salvage strategy can be evaluated in patients whose prostate cancer has relapsed with a limited metastatic burden. The trial focused on relapse-free time rather than only a response measured at one visit. Its endpoint counted biochemical relapse, defined using PSA changes, and/or clinical relapse, defined by an increase in metastatic sites at an evaluation visit.
The registry’s brief summary frames the strategy as an attempt to treat visible oligometastatic disease with high-dose irradiation while using hormonotherapy. It describes the hoped-for clinical purpose as extending the interval between ADT courses or potentially achieving disease control in selected patients. Those aims are background rationale, not findings from the registry’s posted outcome data.
Because the design is single group, the study addresses experience with the combined approach in its enrolled population rather than a direct treatment contrast. Without a concurrent comparator, the record cannot establish how the observed relapse timing would compare with another management strategy. In addition, the registry record does not report the primary endpoint result, so the planned clinical question cannot be answered from the posted results alone.
3. Trial Design
NCT02274779 is a completed phase II study titled “Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer.” Its official title identifies it as the multicentric OLIGOPELVIS / GETUG P07 trial. The sponsor is Institut Cancerologie de l'Ouest. The record lists prostate cancer as the condition and enrollment of 74.
The study model is single group, allocation is recorded as NA, and masking is listed as none. These design features mean that the registry does not describe a randomized, masked comparison between treatment arms. The listed intervention is ELIGARD, and the arm description names high-dose IMRT with ELIGARD. The brief summary describes the strategy as high-dose conformal radiotherapy together with LH-RH agonists.
The record gives a start date of 2014-08-20, a primary completion date of 2018-07-24, and a status of completed. These dates describe the registry’s study timeline; they do not supply a result for the primary endpoint. The registry lists one outcome measure and no posted analyses. A detailed statistical analysis plan, the criteria for the analysis population, and the handling of participants who did not complete treatment or follow-up are not reported in the registry record.
The arm description includes technical radiotherapy details, but the description is incomplete in the record. It identifies targets and dose schedules, but the available text ends partway through the treatment description. It is therefore not possible to reconstruct the full radiation protocol from this record alone. Nor does the record state whether treatment delivery or follow-up differed from the intended approach.
As a phase II single-group study, the design can document outcomes and safety observations in the treated study context, but it cannot by itself separate treatment effects from the natural course of disease or other influences. A comparator, randomization procedure, and masking approach are not reported as features of this study.
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
| Stage | Hight Dose IMRT, ELIGARD |
|---|---|
| STARTED | 74 |
| COMPLETED | 67 |
| NOT COMPLETED | 7 |
Reasons for not completing this period:
| Reason | Hight Dose IMRT, ELIGARD |
|---|---|
| Lost to Follow-up | 1 |
| Protocol Violation | 6 |
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 | Hight Dose IMRT, ELIGARD |
|---|---|---|
| Participants analysed | 67 | |
| Age, Continuous | years | 68 (64 to 72) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 67 |
| Race and Ethnicity Not Collected | Participants | — |
| Region of Enrollment: France | Participants | 67 |
6. Primary Endpoint
The registry lists the primary outcome as Median Relapse-Free Survival Time (Biochemical or Clinical), measured over 2 years.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The primary outcome is median relapse-free survival time, measured in months. The registry defines the interval as beginning at treatment initiation and ending at biochemical or clinical relapse. Biochemical relapse is defined as a PSA level greater than the PSA before treatment, confirmed by two consecutive increases in the same laboratory. Clinical relapse is defined as an increase in the number of metastatic sites at the evaluation visit. The outcome can be reached by either type of relapse, according to the record.
A time-to-event endpoint is useful when the timing of an event matters and participants may have differing lengths of observation. Rather than reducing follow-up to whether relapse occurred by a single cutoff, the measure describes the time from a stated origin to the defined event. The median is the point in the estimated event-time distribution at which half the distribution lies on either side; it is not an average and does not describe every participant’s experience. This is a general explanation of the statistic.
The registry lists a 2 years timeframe, but it does not report a median value or a 95% confidence interval. The timeframe alone should not be read as an observed relapse-free duration or as evidence that follow-up was complete for every participant. The record also does not describe censoring rules or the method used to estimate the median. Those details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clinically relevant endpoint and a treatment strategy, but the posted results do not contain the primary outcome estimate. Although the outcome is titled median relapse-free survival time and its dispersion is specified as a 95% confidence interval, neither the median nor the interval is reported. The record therefore does not support a numerical account of relapse timing in the study.
The design matters when interpreting what can be learned. This is a single-group phase II study with allocation listed as NA and masking listed as none. There is no separate control group in the record. Any observed relapse experience, if reported elsewhere, would describe outcomes within the study group; without a concurrent comparator, it would not by itself quantify what would have happened under another management strategy. In this registry entry, even that descriptive endpoint estimate is absent.
The primary outcome combines biochemical and clinical relapse under the specified definition. The biochemical definition uses a PSA level greater than the pre-treatment PSA and requires confirmation through two consecutive increases in the same laboratory. The clinical definition refers to an increase in metastatic sites at an evaluation visit. These criteria help clarify what counts as an event, but the record does not give the number of events, follow-up distribution, or a breakdown by relapse type.
The registry lists enrollment of 74, but does not report the number included in the primary endpoint analysis or the number with adequate follow-up. Nor does it report the median estimate, confidence interval, or sponsor analysis for the endpoint. The record lists one outcome measure and no posted analyses. Consequently, the primary endpoint cannot be assessed for magnitude or precision from these registry results.
The safety record includes a group with 67 at risk for serious adverse events and 5 affected, as well as 67 at risk for other adverse events and 5 affected; deaths are listed as 1. These figures are safety observations, not a comparison against another treatment. The record also names serious adverse event terms with percentages, but does not supply event-level timing, attribution, duration, or a comparison group. The counts alone do not establish whether an event was caused by treatment.
The registry’s stated sample-size assumptions describe a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. The study itself is single group, so those assumptions should not be confused with its design or with observed evidence. The record does not provide numerical planning outputs in the outcome information or a sample-size justification for the trial. A planning illustration is not observed power and cannot replace a reported analysis.
Overall, the record supports a description of the study question, design, endpoint definition, and selected safety counts. It does not provide the primary result needed to judge the observed relapse-free time or its precision. No conclusion about comparative benefit follows from this registry entry.
9. Statistical Methods Explained
Time-to-event methods are designed for outcomes where both whether an event occurs and when it occurs are important. In this trial, the event is biochemical or clinical relapse, and the time origin is treatment initiation. The registry specifies the outcome as a median in months. The methodological description of how the median was estimated is not reported in the registry record.
What does a median time-to-event estimate represent?
In general, the median is a summary of the distribution of times to an event. It is distinct from a mean, which averages observed values, and it does not imply that every participant experiences the event at the median time. In time-to-event data, some participants may not have had the event by the end of their observed follow-up. Their information is usually handled as censored: it contributes information up to the last time they were known to be event-free, without treating that time as if relapse had occurred. This is a general explanation, not a description of the analysis used in this study. The registry does not report its censoring rules or estimation method.
Why does the confidence interval matter?
A confidence interval communicates uncertainty around an estimate. A narrow interval generally indicates greater precision than a wide interval, while an interval spanning a broad range leaves more uncertainty about the underlying value. This is a general statistical interpretation. The registry names a 95% confidence interval as the intended measure of dispersion for the median relapse-free time, but does not report the interval itself. As a result, its precision cannot be evaluated from the posted results.
How should a single-group design be read?
In a single-group study, participants receive the study strategy without a separately listed control group. The resulting outcome can describe the experience of the study group, but it does not create a randomized contrast. General differences between patients, disease course, concurrent care, or other influences may affect outcomes. A randomized comparison is one way to balance such influences across groups; this record does not describe one. Allocation is NA and the study model is single group.
The registry record lists masking as none. Masking can reduce the influence of knowledge of treatment assignment on certain processes, such as outcome assessment, when a design includes treatment assignments to conceal. In a single-group study, the implications differ from those in a blinded comparative trial. The record does not describe procedures intended to limit assessment bias, nor does it give additional operational details.
What does the endpoint definition contribute?
Clear event criteria are important because different definitions can yield different event times. Here, biochemical relapse requires a PSA level greater than the pre-treatment PSA, confirmed by two consecutive increases in the same laboratory. Clinical relapse is defined through an increase in the number of metastatic sites at an evaluation visit. The use of “or” in the outcome description means that either type can meet the composite event definition. The record does not report separate results for the biochemical and clinical components, so their individual contributions cannot be assessed.
The registry lists a 2 years timeframe. A timeframe labels the intended reporting horizon, but does not by itself reveal how long each participant was followed, whether every participant had an event, or how follow-up beyond that horizon was handled. Those details are not reported in the registry record. The timeframe should not be substituted for a median estimate.
What can sample-size planning illustrations tell readers?
Sample-size planning uses assumptions about the effect to detect, the significance threshold, allocation, and statistical model to illustrate the amount of information a future study may require. The registry’s planning assumptions specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. For time-to-event planning, the description says the output concerns total events; for other outcomes it concerns participants per arm. These are planning conventions, not a report of the design actually used in this single-group study.
Such illustrations depend on their assumptions and do not establish that a study had adequate power after the fact. They are not observed power. The registry does not report the study’s own sample-size justification, the assumed event rate or follow-up pattern, or how a planning calculation informed the enrollment of 74. No planning output should be treated as a result for this trial.
Why is over-dispersion relevant in general?
For count outcomes, a simple statistical model may assume that variation is tied closely to the mean. If observed variation is larger than that assumption allows, the data are over-dispersed. Ignoring over-dispersion can make uncertainty appear smaller than it is. This is a general methodological point and does not describe the primary endpoint here, which is time-to-event. The registry does not report an over-dispersion assessment or a count-based primary analysis.
The record indicates no posted analyses and does not report a hazard ratio for the primary endpoint. Hazard ratios compare event rates over time between groups in a specified model; they are not the same quantity as a median time. Since this trial has no separate comparator group listed and no analysis is posted, no comparative hazard-ratio interpretation can be made from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when a study conducts several statistical tests or evaluates several endpoints. The more opportunities there are to identify a result by chance, the more important it is to understand whether the analysis plan addressed that issue. The registry lists one outcome measure, the median relapse-free survival time, and no posted analyses. Whether additional analyses were planned or performed, and whether any multiplicity procedure was used, is not reported in the registry record.
The record does not identify a primary analysis population, such as an intention-to-treat or per-protocol population. It lists enrollment of 74, but does not state how many participants contributed to the primary endpoint analysis or whether anyone was excluded. The definition of the analyzed population is therefore not available for assessing how well the analysis represents the enrolled study group.
Missing outcome data can affect a time-to-event analysis if the timing or reasons for loss to follow-up are related to relapse risk. General methods can account for incomplete observation through censoring, but interpretation depends on when follow-up ended and why. The registry does not report missing-data counts, follow-up completeness, withdrawal information, censoring rules, or sensitivity analyses. It is not possible to determine whether incomplete observation could have affected the endpoint estimate.
The record also does not report an interim-analysis plan, stopping rules, or a statistical analysis plan. These omissions should be treated as unknowns, not evidence that such procedures were or were not used. With no posted primary estimate and no analysis details, neither multiplicity control nor the impact of missing data can be evaluated.
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 |
|---|---|---|---|
| Hight Dose IMRT, ELIGARD | 5 | 67 | 7.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Hight Dose IMRT, ELIGARD | 1 of 67 |
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 |
|---|---|
| Hight Dose IMRT, ELIGARD | 5 of 67 |
Most frequent serious adverse event terms
| Event term | Organ system | Hight Dose IMRT, ELIGARD |
|---|---|---|
| Recto-sigmoid junction stenosis | Gastrointestinal disorders | 1 of 67 |
| post radiation proctatis | Surgical and medical procedures | 1 of 67 |
| sylvian stroke | Nervous system disorders | 1 of 67 |
| urinary retention | Renal and urinary disorders | 1 of 67 |
| incontinence | Renal and urinary disorders | 1 of 67 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Hight Dose IMRT, ELIGARD |
|---|---|---|
| genito-urinary | Renal and urinary disorders | 5 of 67 |
Serious events with the highest arm-level rate: recto-sigmoid junction stenosis (1.5%), post radiation proctatis (1.5%), sylvian stroke (1.5%), urinary retention (1.5%), incontinence (1.5%).
The registry lists one safety group, titled “Hight Dose IMRT, ELIGARD.” It reports 67 at risk for serious adverse events and 5 affected. For other adverse events, it likewise reports 67 at risk and 5 affected. Deaths are listed as 1. These are registry counts; they do not compare the regimen with an alternative group.
The named serious adverse event terms are recto-sigmoid junction stenosis, post radiation proctatis, sylvian stroke, urinary retention, and incontinence. Each is reported with 1.5%. The record does not explain the denominator used for these percentages or whether they represent participants, events, or another reporting basis. The listed terms should therefore be read as registry-reported safety entries, not as a complete account of all possible adverse effects.
Adverse-event summaries depend on definitions, collection periods, attribution rules, and the number of people assessed. Those details, including the relationship of each event to treatment, are not reported in the registry record. A count of affected participants does not establish causation, and a listed death cannot be attributed to the intervention based on this information alone. Without a comparator, the record also cannot quantify excess risk relative to another strategy.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed phase II, single-group study of salvage radiotherapy combined with hormonotherapy for oligometastatic pelvic-node relapse of prostate cancer. It defines a primary time-to-event outcome and lists selected safety counts. These details show what the study set out to assess and what safety information the registry contains.
The record does not report the median relapse-free survival time or its 95% confidence interval. It therefore does not show the observed duration of relapse-free time or how precisely that duration was estimated. The 2 years timeframe is a reporting label, not a result. The absence of an estimate means that the primary outcome cannot be judged from this registry entry.
The single-group design also limits comparative interpretation. Even if an outcome estimate were available, the study would describe the experience of the group rather than establish how the same population would have fared under another approach. The registry does not list a randomized comparator, and it does not report a treatment effect relative to another strategy.
The safety entries describe recorded counts and named serious adverse event terms, but they do not establish that treatment caused those events. The record does not report attribution, event timing, or a comparison group, and the basis for the listed percentages is not explained. These limitations prevent a comparative safety assessment.
Thus, the registry supports a cautious description of the study design, endpoint definition, and selected safety observations. It does not support a conclusion about the magnitude of the primary outcome, its precision, or comparative effectiveness. Any broader interpretation would require outcome and analysis details not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable for the gap between a clearly named time-to-event endpoint and the absence of a posted endpoint estimate. The registry defines relapse using biochemical and clinical criteria and specifies median time as the summary measure. Yet without the median and its confidence interval, readers cannot assess either the observed outcome or its precision. This illustrates why endpoint definitions alone are not enough to interpret a trial.
The single-group design is also central to the statistical reading. It can provide descriptive evidence about a study group, but it does not supply a randomized treatment contrast. This distinction matters especially when the clinical rationale anticipates an effect on the course of disease: a rationale is not an estimate of treatment effect, and a single-group outcome cannot independently establish what would have happened under another strategy.
The registry also makes clear why planning calculations should be kept separate from trial results. Its stated assumptions describe an illustration using equal allocation between two arms, even though the listed study model is single group. A planning illustration can help frame future research, but it is not an account of the actual design and does not represent observed power. The record does not report the trial’s own sample-size justification.
Finally, the safety record shows how counts and percentages can be difficult to interpret without denominators, event definitions, attribution, and comparison data. The entries are useful descriptive signals, but they do not quantify comparative risk. Taken together, these features emphasize the value of complete registry results: an endpoint estimate, uncertainty interval, analysis population, and methods are needed to move from a study description to a statistically interpretable result.
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 principal limitation of this registry entry is that it does not report the primary endpoint result. Although the outcome is defined as median time to biochemical or clinical relapse and the intended dispersion is a 95% confidence interval, neither is available. The registry also lists no posted analyses. This prevents interpretation of the endpoint’s magnitude, uncertainty, and statistical analysis.
The single-group design has no concurrent comparator in the record. It therefore cannot provide a randomized estimate of the difference between this strategy and another approach. Allocation is NA, and masking is listed as none. These features constrain causal and comparative conclusions, independent of the missing outcome result.
Important analysis details are absent. The registry does not report the primary analysis population, the number analyzed, follow-up completeness, censoring rules, handling of missing data, or sensitivity analyses. It also does not report a statistical analysis plan, multiplicity procedures, interim analyses, or stopping rules. These omissions leave uncertainty about how the outcome was analyzed and how robust any unposted result might be.
The safety information is limited to the registry’s group counts and named serious adverse event terms with percentages. The record does not clarify the percentage denominators, event attribution, timing, collection procedures, or comparative safety. The arm description is also incomplete, ending partway through the treatment details, so the full radiotherapy regimen cannot be reconstructed from this entry alone.
Finally, enrollment is listed as 74, but the record does not explain how that figure relates to the endpoint analysis or to the stated planning illustration. The trial’s sample-size justification is not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer — NCT02274779.
- Registry record last updated 2026-02-13; status last verified 2025-09.
- Results first posted 2026-02-13.
- 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
NCT02274779 is a completed phase II, multicentric, single-group study of salvage radiotherapy combined with hormonotherapy for oligometastatic pelvic-node relapse of prostate cancer. Its official title identifies it as OLIGOPELVIS / GETUG P07. The registry lists enrollment of 74, Institut Cancerologie de l'Ouest as sponsor, and dates from 2014-08-20 to primary completion on 2018-07-24.
The primary outcome is median time from treatment initiation to biochemical or clinical relapse, with a 2 years timeframe and a specified 95% confidence interval. The registry does not report the median or interval and lists no posted analyses. Safety entries include 5 affected among 67 at risk for serious adverse events, 5 affected among 67 at risk for other adverse events, and 1 death. The record does not provide a comparator or enough analysis detail for comparative conclusions.