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 A Phase I/II Trial of 2-Deoxyglucose (2DG) for the Treatment of Advanced Cancer and Hormone Refractory Prostate Cancer (NCT00633087), a na phase 1, phase 2 study. The primary outcome is To Determine the Biochemical Response of This Regimen in Patients With HRPC.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00633087 |
| Phase | Phase 1, Phase 2 |
| Condition | Prostate Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Rutgers, The State University of New Jersey |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes a study of people with advanced solid tumors and hormone-refractory prostate cancer. Prostate cancer is the listed condition. The primary endpoint specifically refers to patients with HRPC. The record lists enrollment of 12, but the primary outcome population is marked “No data collected.” Further eligibility details are not reported in the registry record.
Intervention
The intervention was 2-deoxyglucose, abbreviated 2DG. The study description says participants would take an oral solution daily. It frames the study as an examination of safety and biochemical response. The administered dose, dose changes, adherence, and duration actually received are not reported in the registry record.
Comparator
This was a single-group study, with no randomized allocation and no masking. The registry does not list a separate control group or an active comparator. Consequently, the record does not support a like-for-like comparison between 2DG and another treatment or control condition.
Primary question
The primary question was whether the regimen produced a biochemical response in patients with HRPC. The stated response definition was a PSA decrease of 50% from baseline maintained for at least 28 days, with a 5-year timeframe. The registry record reports no primary outcome data, so it does not establish how many participants met that definition.
3. Trial Design
The registry identifies this as a Phase I/II study of 2-deoxyglucose (2DG) for advanced cancer and hormone-refractory prostate cancer. It lists Rutgers, The State University of New Jersey, as sponsor, enrollment of 12, and a single-group model. Allocation is recorded as not applicable, and masking as none. There is no separate randomized control arm in the record.
The study description says participants would take an oral solution of 2DG daily. It describes safety evaluation in people with advanced solid tumors and hormone-refractory prostate cancer, and says information from the study would inform future clinical studies. The planned assessments described include imaging and blood work. The record does not report the dose, the detailed treatment schedule, or which participants received which assessments.
The start is listed as 2006-11, primary completion as 2011-03, and status as terminated. The reason for termination and the circumstances around the end of the study are not reported in the registry record. These dates and status do not, by themselves, explain whether planned enrollment or follow-up was completed.
The registry lists duration of response, progression-free survival, and overall survival as secondary outcomes. It does not provide outcome estimates or analyses for them. The primary endpoint is a PSA-based biochemical response, but its population is explicitly marked “No data collected.” Thus the design and endpoint can be described, while clinical outcome results cannot be interpreted from this record.
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 | 2-deoxyglucose |
|---|---|
| STARTED | 12 |
| COMPLETED | 12 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: No data collected
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 | 2-deoxyglucose |
|---|---|---|
| Participants analysed | 12 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 |
| Age, Categorical: >=65 years | Participants | 9 |
| Age, Continuous | years | 65.3 (SD 12.0) |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 11 |
| Region of Enrollment: United States | participants | 12 |
6. Primary Endpoint
The registry lists the primary outcome as To Determine the Biochemical Response of This Regimen in Patients With HRPC, measured over 5 years.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is biochemical response in patients with HRPC. The registry defines a PSA response as a PSA decrease of 50% from baseline maintained for at least 28 days. PSA is the biomarker named in the endpoint; the record does not report the measurement schedule, assay details, or rules for handling missing measurements.
A response definition turns a continuous biomarker change into a criterion that can be classified as met or not met. Requiring the decrease to be maintained for a specified period distinguishes a sustained change from a transient measurement. This can make the endpoint easier to interpret as a response measure, but it does not make it equivalent to a direct measure of survival, symptoms, or overall health.
The stated timeframe is 5 years. The registry does not explain whether this is the time allowed for response assessment, the total follow-up window, or another endpoint-specific period. Nor does it report how many participants had evaluable baseline and follow-up PSA measurements. Most importantly, the primary outcome population is marked “No data collected.” There is therefore no reported response count, response proportion, estimate of uncertainty, or comparison to interpret.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record describes the question and endpoint, but it does not report primary outcome data. The primary endpoint field identifies a PSA response threshold: a decrease of 50% from baseline maintained for at least 28 days. It also lists a 5-year timeframe. No count of participants meeting the criterion, response estimate, or uncertainty interval appears in the registry record. A response rate cannot be inferred from the enrollment count.
The design is single-group and unmasked, with allocation listed as not applicable. This means the registry does not describe a randomized comparator against which to estimate a treatment contrast. Even if a within-group change had been reported, changes over time in a single group cannot, on their own, separate an intervention effect from other explanations. That is a general limitation of uncontrolled comparisons, not a conclusion about what happened to participants in this study.
The record lists 12 participants as enrolled and describes a terminated study. Enrollment is not interchangeable with the number included in an endpoint analysis. The record does not report how many participants started treatment, completed follow-up, had measurable PSA data, or were included in any analysis. It also does not report the reasons for termination. Those omissions prevent assessment of outcome completeness and the relationship between enrollment and the primary endpoint population.
The secondary outcomes include duration of response, progression-free survival, and overall survival. Their names indicate distinct questions: how long a response lasts, how long participants remain free of progression, and how long they survive. The record provides no estimates, event counts, follow-up summaries, or analysis details for these outcomes. Their inclusion as registered outcomes is not evidence that results were observed or that they favored any direction.
Safety information is reported separately. The registry lists 3 participants affected by serious adverse events and 10 affected by other adverse events, each among 12 at risk. These counts describe reported safety categories; they do not establish causation. The registry also lists three serious-event terms, each with a frequency of 8.3%. The record does not provide enough detail to determine event timing, duration, severity grading beyond the serious classification, or whether one participant could contribute to more than one term.
Overall, the posted record supports a description of a small, single-group Phase I/II study and its planned biochemical endpoint. It does not support a quantitative conclusion about biochemical response or the secondary outcomes. That distinction matters: a defined endpoint is not the same as an observed result, and safety counts are not a substitute for efficacy estimates.
9. Statistical Methods Explained
The record identifies a single-group study with no masking and no randomized allocation. The registry gives no statistical analysis count and does not provide an analysis plan. The concepts below explain how such design features relate to interpretation in general; they do not assert that a particular method was used in this study.
What does a single-group design estimate?
A single-group design can describe outcomes observed among participants who receive an intervention. If baseline and follow-up measurements are collected, investigators may describe within-participant changes or the fraction meeting a response definition. Such summaries do not, by themselves, estimate what would have happened to the same participants without the intervention. A concurrent comparison group can help address that counterfactual question, especially when assignment is randomized. This registry record lists no comparator, so a randomized between-group treatment effect is not available to interpret.
In an uncontrolled study, changes can reflect the intervention, the natural course of disease, other care, measurement variation, or selective availability of follow-up data. This is a general issue of causal inference. It does not show that any particular alternative explanation occurred in this study. The absence of masking can also matter in general when outcomes or decisions involve judgment, although the primary endpoint is defined using a PSA threshold. The record does not describe outcome-assessment procedures or safeguards against bias.
How should a response endpoint be understood?
The registered response rule requires a PSA decrease of 50% from baseline maintained for at least 28 days. This is a threshold-based endpoint: a measured biomarker change is classified against a prespecified rule. Thresholds can make results easier to summarize, but they discard information about the size and pattern of changes beyond the classification. A participant just meeting the threshold and one with a larger decrease would both meet the stated definition. Conversely, a change that does not satisfy the full rule would not count as a response under that definition.
To estimate a response proportion, an analysis needs a clearly defined population and a way to determine which participants meet the rule. It also needs a decision about participants with missing or unevaluable measurements. The registry record reports neither the response count nor those analysis details. Therefore, no response proportion or confidence interval can be interpreted from the registry entry.
What does a confidence interval convey?
In general, a confidence interval expresses uncertainty around an estimate under a statistical model and its assumptions. A narrow interval indicates greater statistical precision than a wide interval, while neither width nor location resolves systematic bias. For an outcome proportion, uncertainty depends in part on how many participants contribute usable outcome data and how many meet the response definition. Since the registry record reports no primary outcome data, there is no posted primary estimate or interval to assess for precision.
What are time-to-event outcomes?
Duration of response, progression-free survival, and overall survival are time-to-event outcomes. In general, these methods account for the time until an event and can include participants whose event has not been observed by the end of follow-up through censoring. Censoring is not the same as an event: it means the event time is not fully observed within the available follow-up. Interpretation depends on clear event definitions, follow-up, censoring rules, and an analysis method. Those details and outcome results are not reported in the registry record.
Kaplan–Meier curves are a common descriptive approach to time-to-event data, and a hazard ratio may be used in some comparative analyses. These are general methods, not methods confirmed for this study. With no listed control group and no registered analysis results, there is no comparative hazard estimate to explain. The record also does not provide enough information to assess whether follow-up was complete or censoring was informative.
How do planning calculations differ from trial results?
Sample-size calculations are planning tools, not observed outcomes and not proof that a study had adequate precision. A planning illustration described for this analysis uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of an observed effect. The registry describes this study as single-group, so the equal-allocation, two-arm assumptions do not describe its registered design. Such an illustration should not be read as the study's original sample-size justification or as observed power. The registry record does not report the trial's sample-size justification, and the primary outcome is marked as having no data collected. Any illustration based on an observed effect cannot substitute for a result estimate from this study.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when several outcomes, comparisons, time points, or subgroup analyses are examined. In general, testing many questions can increase the chance that at least one result appears noteworthy by chance. Statistical plans may address this through a hierarchy of endpoints, adjusted significance thresholds, or other prespecified strategies. Which approach is appropriate depends on the goals and design. The registry record does not report a multiplicity strategy, confirmatory testing hierarchy, or interim analyses.
The primary endpoint is a PSA-based biochemical response, and the registry lists duration of response, progression-free survival, and overall survival as secondary outcomes. Listing multiple outcomes does not show that each was analyzed or that any result was statistically significant. The registry records zero analyses and marks the primary outcome population as “No data collected.” Outcome estimates and inferential tests therefore cannot be assessed for multiplicity from this record.
Missing data are also important because the registered response definition requires baseline and follow-up PSA information, while time-to-event outcomes depend on follow-up. The record does not report the number of missing measurements, loss to follow-up, reasons for missingness, or methods for handling missing data. It does not describe whether participants without evaluable PSA data would be counted as nonresponders, excluded, or handled another way. These are distinct analytical choices and can affect interpretation.
The analysis population is not reported in the registry record. The enrollment count of 12 should not be assumed to be the number included in every endpoint analysis. The record does not state whether analyses would include all enrolled participants, only those who started treatment, or only participants with evaluable outcome data. Consequently, neither the endpoint denominator nor the handling of participants with incomplete follow-up can be reconstructed.
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 |
|---|---|---|---|
| 2-deoxyglucose | 3 | 12 | 25.0% |
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 |
|---|---|
| 2-deoxyglucose | 10 of 12 |
Most frequent serious adverse event terms
| Event term | Organ system | 2-deoxyglucose |
|---|---|---|
| Pain - Back | General disorders | 1 of 12 |
| Fatigue (asthenia, lethargy, malaise) | General disorders | 1 of 12 |
| Pain (right lower quadrant) | General disorders | 1 of 12 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 2-deoxyglucose |
|---|---|---|
| Fatigue (asthenia, lethargy, malaise) | General disorders | 5 of 12 |
| Prolonged QTc interval | Cardiac disorders | 4 of 12 |
| Pain | General disorders | 2 of 12 |
| Conduction abnormality/atrioventricular heart block | Cardiac disorders | 1 of 12 |
| Pain - Back | General disorders | 1 of 12 |
| Pain - Chest wall | General disorders | 1 of 12 |
| Pain - Pelvis | General disorders | 1 of 12 |
| Constipation | Gastrointestinal disorders | 1 of 12 |
| Gastrointestinal - Other | Gastrointestinal disorders | 1 of 12 |
| Platelets | Blood and lymphatic system disorders | 1 of 12 |
Serious events with the highest arm-level rate: pain - back (8.3%), fatigue (asthenia, lethargy, malaise) (8.3%), pain (right lower quadrant) (8.3%).
The registry lists 12 participants at risk for serious adverse events, with 3 affected, and 12 at risk for other adverse events, with 10 affected. These are separate safety categories in the record. They should be read as reported participant counts, not as proof that 2DG caused the events. The entry does not give a comparison group that could help distinguish event frequency during study participation from background risk.
The listed serious adverse-event terms are Pain - Back, Fatigue (asthenia, lethargy, malaise), and Pain (right lower quadrant), each reported as 8.3%. The registry does not provide term-level counts in the entry, event timing, duration, or details about whether the same participant had more than one event. The percentages should therefore be read as the registry's reported frequencies, not treated as mutually exclusive categories or added together.
The deaths field is null. That means deaths are not reported in the registry record; it should not be interpreted as a reported count of zero. The record also does not report attribution, severity grading details beyond the serious-event classification, or the observation period used for these safety counts. These limitations leave the safety information descriptive and incomplete.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a Phase I/II study of 2DG was registered as a single-group investigation in advanced cancer and hormone-refractory prostate cancer. It identifies a PSA response definition and lists several secondary outcomes. It also reports enrollment of 12 and safety counts. These details explain what the study set out to examine and what information was recorded.
The primary outcome field says “No data collected.” Accordingly, the record does not establish whether participants met the PSA response criterion, how often a response occurred, or how precisely a response could be estimated. It also does not provide findings for duration of response, progression-free survival, or overall survival. The absence of outcome data in this registry entry is not evidence of either benefit or lack of benefit; it is a limit on what can be concluded from this record.
Because the study has no listed comparator, the record cannot support a randomized comparison or isolate the effect of 2DG from other influences. That is a design limitation for causal interpretation, separate from the absence of posted results. Even a reported within-group change would need cautious interpretation without a comparison condition.
The serious and other adverse-event counts offer descriptive safety information but do not establish that the intervention caused those events. Event details and a comparator are not reported. The null deaths field is not a zero count. The reason the study was terminated is also not reported, so termination should not be interpreted as evidence about safety, efficacy, feasibility, or any other particular cause.
In short, the record supports a careful account of study design, endpoint definitions, and reported safety counts. It does not provide the outcome evidence needed to quantify biochemical response or assess the registered survival-related outcomes. No treatment conclusion follows from the registry information alone.
13. Why This Trial Matters Statistically
This study is statistically notable because it separates the definition of an endpoint from evidence about that endpoint. A PSA response rule is clearly stated: a decrease of 50% from baseline maintained for at least 28 days. Yet the primary outcome population is marked “No data collected.” A precise endpoint definition can improve consistency in how a response is classified, but it cannot replace observed outcome data.
The single-group structure also highlights the difference between describing what happened during a study and estimating what the intervention caused. A cohort can be followed and outcomes recorded without a randomized control. However, the lack of a comparator leaves changes open to explanations beyond the intervention. This is a general design principle, rather than a claim about any unreported participant outcome.
The registry's safety counts offer another statistical lesson: counts, percentages, and causal conclusions are not interchangeable. The record reports participants affected by serious and other adverse events, along with selected serious-event terms. Without detailed event histories, attribution, or a comparator, those figures remain descriptive. Likewise, the null deaths field must not be read as an observed zero.
Finally, the record shows why completeness of registration results matters. It lists secondary time-to-event outcomes but no analyses, and the primary outcome is marked as not collected. Without outcome estimates, denominators, follow-up information, and analysis details, readers cannot evaluate precision, missingness, or the extent to which results answer the registered questions. The statistical importance lies in recognizing these boundaries rather than filling them with assumptions.
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 gives limited information about eligibility, baseline characteristics, actual treatment exposure, and follow-up. Although it describes daily oral 2DG, it does not report dose, treatment duration actually received, adherence, or dose modifications. The study description mentions planned clinical assessments, but the record does not establish which were completed for enrolled participants.
The listed enrollment is 12, but the number contributing to each outcome is not reported. The primary endpoint population is marked “No data collected,” and the registry records no analyses. As a result, there is no primary outcome estimate, denominator, uncertainty measure, or account of exclusions to evaluate. Reasons for missing data and methods for handling it are not reported in the registry record.
The single-group, unmasked design has no listed randomized comparator. This limits causal interpretation in general and prevents a like-for-like treatment comparison in the registry record. Statistical methods, including any analysis model, multiplicity plan, or interim analysis, are not reported. The record also does not give the sample-size justification.
The study status is terminated, but the reason for termination is not reported. The record does not explain whether the planned follow-up period was completed or how the listed 5-year timeframe was applied. Safety reporting lacks event timing, duration, attribution, and detailed death information; the deaths field is null rather than a reported zero. These trial-specific gaps preclude fuller assessment of outcome completeness, precision, and safety context.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase I/II Trial of 2-Deoxyglucose (2DG) for the Treatment of Advanced Cancer and Hormone Refractory Prostate Cancer — NCT00633087.
- Registry record last updated 2023-12-22; status last verified 2023-12.
- Results first posted 2014-01-07.
- 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, single-group study of 2-deoxyglucose for advanced cancer and hormone-refractory prostate cancer. Rutgers, The State University of New Jersey, is listed as sponsor, and enrollment is 12. The study is marked terminated; the reason is not reported in the registry record.
The primary endpoint is a PSA decrease of 50% from baseline maintained for at least 28 days, with a stated timeframe of 5 years. The primary outcome population is marked “No data collected.” Duration of response, progression-free survival, and overall survival are listed as secondary outcomes, with no analyses reported.
The registry reports 3 participants affected by serious adverse events and 10 affected by other adverse events, each among 12 at risk. The deaths field is null. The record does not provide outcome estimates or enough detail to infer treatment effects or event causation.