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 Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients (NCT01313273), a randomized phase 3 study. The primary outcome is Progression-free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01313273 |
| Phase | Phase 3 |
| Condition | Prostate Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 3 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ipsen |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with nonmetastatic castration-resistant prostate cancer and elevated chromogranin A levels. The registry record describes early termination due to poor enrollment and gives an enrollment of 3. It does not report further eligibility details or a fuller description of the enrolled population.
Intervention
The intervention was lanreotide added to nonsteroidal antiandrogens and LHRH-a. The study aim describes this as an exploratory comparison of progression-free survival. The registry record does not give further treatment schedules or dose details.
Comparator
The comparator was nonsteroidal antiandrogens and LHRH-a without lanreotide. The study record describes the treatment groups as randomized and parallel, with no masking.
Primary question
The primary question was whether adding lanreotide was associated with a different progression-free survival outcome, assessed at Week 96. The registry record contains no reported primary-outcome estimate or statistical analysis, so it does not establish the direction or size of any difference.
This is a question about a treatment strategy in a narrowly described clinical setting, not about lanreotide in all prostate cancer. The title specifies elevated chromogranin A levels, and the brief summary frames the comparison as exploratory. The record does not report the intended definition of progression, how the endpoint was assessed, or the detailed eligibility criteria. Those omissions limit how precisely the target population and outcome can be reconstructed from the registry entry.
3. Trial Design
The record describes a randomized, phase III, multicenter, open study with a parallel-group design. The two treatment strategies were nonsteroidal antiandrogens plus LHRH-a, with or without lanreotide. The registry lists no masking. Randomization is intended to balance prognostic factors across treatment groups on average, but with very limited enrollment the realized groups may remain imbalanced. The registry does not describe the randomization sequence, allocation concealment, or any stratification factors.
The registered enrollment is 3. The record marks the study as terminated and states that it ended early due to poor enrollment. The start date is 2011-06 and the primary completion date is 2013-06. These registry entries describe the study's status and timing; they do not establish why enrollment was poor or whether any additional reasons contributed to termination.
The primary endpoint is titled Progression-free Survival, with a timeframe of Week 96. The secondary outcomes listed are Prostate Specific Antigen (PSA) Response, Median Time to PSA Response, and Reduction in Chromogranin A Serum Levels. The record lists 4 outcome measures, but it reports 0 analyses. It does not give arm descriptions beyond the intervention names, nor does it provide a detailed statistical analysis plan, recruitment targets, or a sample-size justification. The phase designation and randomized design identify the intended study framework, but they cannot compensate for the absence of outcome analyses. In particular, the record does not permit assessment of whether the planned comparisons were completed or whether the trial's analyses followed an original protocol.
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: Investigators screened 8 subjects. Randomised 3 subjects and 5 were not randomised.
Overall Study
| Stage | Arm A: Non-steroidal Anti Androgens + LHRH-a | Arm B: Lanreotide + Non Steroidal Anti Androgens and LHRH-a |
|---|---|---|
| STARTED | 2 | 1 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 2 | 1 |
Reasons for not completing this period:
| Reason | Arm A: Non-steroidal Anti Androgens + LHRH-a | Arm B: Lanreotide + Non Steroidal Anti Androgens and LHRH-a |
|---|---|---|
| INCLUSION CRITERIA 4 NOT RESPECTED | 1 | 0 |
| Withdrawal by Subject | 1 | 0 |
| Screening Chromogranin A-in normal range | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Study early terminated due to poor enrollment.
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 | Arm A: Non-steroidal Anti Androgens + LHRH-a | Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a | Total |
|---|---|---|---|---|
| Participants analysed | 2 | 1 | 3 | |
| Age, Continuous | years | 72.50 (61.00 to 84.00) | 57.00 (57.00 to 57.00) | 61.00 (57.00 to 84.00) |
| Age, Customized: >=65 years | Participants | 1 | 0 | 1 |
| Age, Customized: Between 18 and 65 years | Participants | 1 | 1 | 2 |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 2 | 1 | 3 |
| Region of Enrollment: Italy | participants | 2 | 1 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival, measured over Week 96.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
Progression-free survival is a time-to-event outcome. In general, such an endpoint measures the time from a defined starting point until a specified event occurs. In oncology studies, progression-free survival commonly concerns progression of disease or death, but the registry record does not state the event definition, assessment schedule, starting point, or rules for censoring in this study. Those details should not be assumed from the endpoint title alone.
The registry names Week 96 as the primary endpoint timeframe. A fixed timeframe can describe the period over which the endpoint is evaluated, but the record does not report a Week 96 estimate, event count, survival curve, confidence interval, or treatment comparison. It also does not explain how disease progression was measured or adjudicated. Consequently, the endpoint's operational definition and the observed outcome cannot be reconstructed from this entry.
In general, progression-free survival is used because it represents the interval before a clinically relevant worsening event, while accounting for the timing of events rather than only a status at a single visit. Interpreting it requires information about event definitions, follow-up, censoring, and the statistical method. Without those details and an outcome analysis, the registry record identifies the endpoint of interest but does not show what the study found.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the registry record does not report a primary-outcome analysis. It names progression-free survival at Week 96, but supplies no estimate, event count, confidence interval, p-value, or analysis population for that endpoint. The record therefore cannot show whether the treatment groups differed, how large any difference might have been, or how precisely an effect was estimated. No direction of effect should be inferred from the study title, its treatment arms, or its intended endpoint.
The study is marked terminated, and the primary-outcome population description says it was terminated early due to poor enrollment. The registered enrollment is 3. This limited enrollment and early termination mean that the record offers no basis for treating the study as a completed, adequately informative comparison. However, the registry does not report a power calculation or a recruitment target, so it is not possible to quantify how far enrollment fell short of an intended target or what precision the investigators expected.
The adverse-event entry gives counts for serious and other adverse events. In the group without lanreotide, 2 were at risk for serious events and 0 were affected; in the group with lanreotide, 1 was at risk and 0 were affected. For other adverse events, the counts at risk are 2 and 1, with affected counts of 0 and 1, respectively. These are descriptive counts, not comparative estimates. They do not establish whether the groups differ in safety, and the record provides no definitions, event details, follow-up duration, or statistical comparison. Death counts are not reported in the registry record.
The secondary outcomes indicate additional intended areas of assessment: PSA response, time to PSA response, and chromogranin A reduction. Their names alone are not results. With 0 analyses reported, the entry supplies no numerical findings for these outcomes. Overall, the registry identifies a randomized comparison and its intended endpoints, but contains too little outcome information to estimate treatment effects or assess their uncertainty. The absence of a reported result is not evidence that the groups had identical outcomes, nor is it evidence for benefit or harm.
9. Statistical Methods Explained
Statistical methods are difficult to assess because the registry record does not provide an analysis plan or any reported analyses. The record identifies randomization, a parallel-group structure, and a time-to-event primary endpoint, but does not describe the statistical test or model used, the handling of censoring, the analysis population, or adjustments for other variables. No method should be attributed to the investigators unless it is documented in the registry record.
What does a time-to-event endpoint require?
In general, time-to-event analysis uses both the timing of events and information from participants whose event has not been observed by the end of their follow-up. Those participants are commonly treated as censored at their last known assessment, but the registry record does not report how censoring was defined or handled in this study. A valid interpretation also depends on consistent event definitions and follow-up procedures across groups. The record does not give these details, so it is not possible to determine how a progression-free survival analysis would have been implemented.
In general, a survival curve can describe the probability of remaining event-free over time, while a treatment comparison may use a model or test that incorporates follow-up time. A hazard ratio, if used, would describe a relative event rate over follow-up under assumptions about the model; an absolute survival estimate at a specified time would answer a different question. The registry record reports neither such estimates nor the method used to obtain them. It would therefore be inappropriate to infer a hazard ratio, a survival probability, or a test result from the endpoint title or the enrollment information.
Why does the missing analysis plan matter?
In general, a prespecified statistical plan clarifies which outcomes and comparisons are primary, how missing measurements and protocol deviations are handled, and which models or tests are intended. It also helps distinguish planned analyses from exploratory ones. Here, the study summary characterizes the efficacy comparison as exploratory, but the registry record does not describe a full plan or report analyses. It does not identify a primary analysis population, an intention-to-treat approach, a per-protocol approach, covariate adjustment, or sensitivity analyses.
The record's sample-size description characterizes planning illustrations as based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. For time-to-event tables, it specifies total events using the Schoenfeld method; for other outcomes, it specifies participants per arm. These are planning assumptions, not evidence of the trial's original design justification and not observed power. The registry does not report an original sample-size justification. It also does not provide the observed primary effect or an endpoint analysis from which the planning illustration could be independently understood.
In general, power is a design-stage probability calculated under specified assumptions about an effect, variability, significance threshold, and sample size. It is not a measure of whether a completed study has demonstrated an effect. Sample-size calculations based on an observed effect are especially dependent on that effect estimate and should be understood as planning illustrations rather than as a substitute for confidence intervals or direct interpretation of trial results. No numerical planning results are reported in the registry record.
How should precision be judged?
In general, a confidence interval describes a range of values compatible with the data and the analysis assumptions. Its width conveys precision: a wider interval indicates greater uncertainty. A p-value addresses compatibility with a null hypothesis under a specified model; it does not give the probability that the null hypothesis is true or measure clinical importance. Neither a confidence interval nor a p-value is reported for the primary endpoint in this record. The enrollment and adverse-event counts cannot be used to reconstruct them, particularly because the record lacks the primary event data and analysis details.
Finally, randomization supports a fair comparison in principle, but does not guarantee balanced groups in a study with very limited enrollment. Statistical methods can account for some features of the data, but cannot create information that was not collected or reported. In this record, the key limitation is not a choice between competing models: it is the absence of the primary outcome analysis and the methods needed to interpret one.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint and secondary outcomes, but does not report a multiplicity strategy. Multiplicity arises when several outcomes, time points, or comparisons are examined: the chance of at least one apparently unusual result can increase when many tests are conducted. In general, investigators may control this risk through prespecified testing sequences, adjusted significance thresholds, or by treating secondary analyses as exploratory. The registry record does not say whether any such approach was planned or used.
The record names Prostate Specific Antigen (PSA) Response, Median Time to PSA Response, and Reduction in Chromogranin A Serum Levels as secondary outcomes. It lists 4 outcome measures and 0 analyses. The primary endpoint description specifies Week 96, but does not provide additional assessment times or outcome categories. No multiplicity-adjusted results, unadjusted results, or corresponding p-values are reported. It is therefore not possible to determine whether any endpoint was tested, whether all planned endpoints were reported, or whether analyses were prespecified.
Missing-data handling and analysis populations are also not reported in the registry record. There is no description of withdrawals, incomplete follow-up, missing biomarker measurements, censoring rules, or imputation. The record does not identify an intention-to-treat, per-protocol, or safety analysis population for efficacy results. These omissions matter because the analysis population and missingness assumptions can influence both estimates and their uncertainty. The early termination for poor enrollment is reported, but the record does not explain how early termination affected endpoint collection or analysis. No conclusions about the handling or impact of missing data can be drawn.
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 |
|---|---|---|---|
| Arm A: Non-steroidal Anti Androgens + LHRH-a | 0 | 2 | 0.0% |
| Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a | 0 | 1 | 0.0% |
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 |
|---|---|
| Arm A: Non-steroidal Anti Androgens + LHRH-a | 0 of 2 |
| Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a | 1 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm A: Non-steroidal Anti Androgens + LHRH-a | Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 0 of 2 | 1 of 1 |
| Transaminases increased | Investigations | 0 of 2 | 1 of 1 |
The registry reports serious and other adverse-event counts by group. For serious adverse events, the group receiving nonsteroidal antiandrogens plus LHRH-a had 2 at risk and 0 affected; the group receiving lanreotide with those treatments had 1 at risk and 0 affected. For other adverse events, the corresponding at-risk counts were 2 and 1, and the affected counts were 0 and 1. These are counts as recorded, not percentages or rates.
The entry does not give event descriptions, definitions, severity grading, timing, follow-up duration, or statistical comparisons. It also does not report death counts. A count of 0 affected in a small group does not establish that an event cannot occur, and a count of 1 in the other-event category does not by itself indicate a difference between treatment strategies. The groups are too limited in reported size for these figures to support a reliable comparative safety conclusion. The counts should be read as registry summaries only, not as estimates of relative risk or proof of safety.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, open, parallel-group phase III study was registered to compare lanreotide plus nonsteroidal antiandrogens and LHRH-a with the latter treatments alone in nonmetastatic castration-resistant prostate cancer patients with elevated chromogranin A levels. It identifies progression-free survival at Week 96 as the primary endpoint and lists additional PSA and chromogranin A outcomes. It also records early termination due to poor enrollment.
It does not establish an efficacy result. There is no reported progression-free survival estimate, treatment contrast, confidence interval, p-value, or analysis population. There are no reported analyses for the secondary outcomes either. Consequently, the record cannot show whether adding lanreotide changed progression-free survival, whether any difference was clinically meaningful, or how uncertain an estimate would be. The absence of an analysis must not be interpreted as evidence of no effect.
The safety figures are similarly limited. They report affected counts in the registry's serious and other adverse-event categories, but do not include event descriptions or comparative estimates. The enrollment was 3, and the record says the study ended early because of poor enrollment. That context makes the available counts particularly unsuitable for broad conclusions about harms or benefits. The entry also does not report the detailed eligibility rules, treatment schedules, endpoint definitions, missing-data procedures, or analysis plan needed for a fuller appraisal.
In general, a trial's design describes the question it set out to answer, while its results determine what the data can support. Here, the design and intended outcomes are identifiable, but a primary analysis is not. The record therefore supports a description of the trial's aims and limitations, not a conclusion about the comparative effects of the treatment strategies.
13. Why This Trial Matters Statistically
This trial matters statistically as an example of the difference between a carefully specified research question and an informative set of reported results. Randomization and a parallel-group design describe an approach intended to compare treatment strategies fairly. Yet a design cannot answer its own question without reported outcome data and analyses. The registry identifies progression-free survival at Week 96 as the primary endpoint, but gives no estimate or analysis for it.
Early termination due to poor enrollment is central to interpreting the record. The registered enrollment is 3, and the entry reports 0 analyses. These details limit the amount of information available for assessing the planned comparison. They also illustrate why enrollment alone is not a substitute for endpoint results: without the event data, follow-up information, and a defined analysis, the treatment effect and its precision cannot be evaluated.
The study also highlights the importance of transparent reporting. Details such as endpoint definitions, censoring rules, analysis populations, missing-data handling, and multiplicity plans help readers distinguish a prespecified analysis from exploratory assessment and understand its assumptions. Those details are not reported in the registry entry. Their absence does not imply that investigators did not have procedures, but it prevents readers from assessing them through this record.
Finally, sparse safety counts require restraint. Descriptive event counts can document what the registry records, but without additional context they do not establish comparative risk. The statistical lesson is not that the intended comparison is unimportant; it is that an intended comparison and a registered endpoint should not be mistaken for evidence of an observed treatment effect.
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 limitations specific to this study record begin with early termination due to poor enrollment. The registered enrollment is 3, and the record reports 0 analyses. It therefore does not present a primary efficacy estimate or secondary-outcome results. Without these, the comparative effect and its precision cannot be evaluated.
The primary endpoint is named Progression-free Survival and has a Week 96 timeframe, but its operational definition is not reported in the registry record. The entry does not specify the starting point for measuring time, which events counted as progression, how progression was assessed, or how censoring was handled. The listed secondary outcomes likewise lack detailed definitions, assessment schedules, and result summaries.
The record identifies the study as randomized, open, multicenter, and parallel, but does not report the randomization method, allocation concealment, stratification, treatment schedules, or masking procedures beyond stating that masking was absent. It does not give detailed eligibility criteria or describe participant characteristics. This limits assessment of how well the enrolled population represents the population named in the title and summary.
There is no reported statistical analysis plan, sample-size justification, analysis population, missing-data approach, or multiplicity strategy. The planning-illustration description does not replace a report of the original design assumptions or an analysis of the observed outcomes. Safety reporting is also limited: event details, definitions, timing, follow-up, and death counts are not reported in the registry record. These gaps should be treated as limits of the available registry information, not as proof that corresponding procedures or data did not exist.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients — NCT01313273.
- Registry record last updated 2019-11-22; status last verified 2019-11.
- Results first posted 2015-08-14.
- 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
NCT01313273 is a randomized, phase III, multicenter, open, parallel study of lanreotide added to nonsteroidal antiandrogens and LHRH-a versus those treatments alone in nonmetastatic castration-resistant prostate cancer patients with elevated chromogranin A levels. The primary endpoint was progression-free survival at Week 96. Listed secondary outcomes include PSA response, median time to PSA response, and reduction in chromogranin A serum levels.
The registry gives an enrollment of 3, a status of terminated, and states that the study ended early due to poor enrollment. It lists 4 outcome measures and 0 analyses. No primary or secondary efficacy estimates are reported. Serious and other adverse-event counts are recorded by group, but the entry provides no event details or comparative safety analysis. The registry record therefore describes the planned comparison but does not provide an outcome analysis from which treatment effects can be judged.