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 Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency (NCT03442556), a na phase 2 study. The primary outcome is Radiographic Progression Free Survival Assessed by Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1/Prostate Cancer Working Group 3 (PCWG3) Criteria.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03442556 |
| Phase | Phase 2 |
| Condition | ATM Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 18 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Washington |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with metastatic castration-resistant prostate cancer and homologous recombination DNA repair deficiency. The listed conditions include ATM, BRCA1, and BRCA2 gene mutations, along with other prostate cancer and disease-characteristic terms. The registry record reports enrollment of 18 participants. It does not give further participant-level detail in the information available for this analysis.
Intervention
The treatment strategy began with induction docetaxel and carboplatin. Patients were to receive both drugs intravenously on day 1, with treatment repeating every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. The strategy then included maintenance rucaparib camsylate by mouth twice daily on days 1-28, in repeating 28-day cycles. The maintenance description in the registry record is truncated, so additional conditions for continuing treatment cannot be stated.
Comparator
There was no separate comparison group: the study is recorded as single-group, with allocation listed as NA. The treatment phases are sequential components of the strategy, not randomized or concurrent control arms. Accordingly, the record does not provide a like-for-like estimate comparing this regimen with another treatment.
Primary question
The primary endpoint was radiographic progression-free survival, measured from the first dose of docetaxel and carboplatin until the first objective evidence of radiographic progression or death from any cause, whichever occurred first. Progression assessment was defined using RECIST 1.1 and PCWG3 criteria, with investigator assessment for soft-tissue progression and confirmed bone disease progression. The registry record does not report the endpoint’s median or 95% confidence interval. Therefore, the numerical outcome and its precision cannot be described from the record.
3. Trial Design
This was a phase 2, single-group study sponsored by the University of Washington. The registry lists allocation as NA and masking as none. These design features mean the study was not a masked, randomized comparison between treatment groups. Its stated treatment sequence was induction chemotherapy with docetaxel and carboplatin, followed by maintenance rucaparib camsylate.
During induction, docetaxel and carboplatin were administered intravenously on day 1, with cycles repeating every 21 days for 4 cycles, unless disease progression or unacceptable toxicity occurred. The maintenance description lists rucaparib camsylate by mouth twice daily on days 1-28, with cycles repeating every 28 days. The description ends mid-sentence in the registry record; further details about maintenance continuation are not reported in the registry record.
The registry reports enrollment of 18 participants. The listed conditions identify metastatic castration-resistant prostate cancer and homologous recombination DNA repair deficiency, including ATM, BRCA1, and BRCA2 gene mutations. The record does not provide enough detail to characterize the enrolled cohort beyond its listed conditions and the overall enrollment.
The study start date is 2018-08-24, the primary completion date is 2025-06-04, and the current status is terminated. A reason for termination is not reported in the registry record. The record also does not report the protocol’s sample-size justification, any interim analyses, or a detailed statistical analysis plan. These omissions prevent conclusions about the intended statistical operating characteristics or whether planned analyses were changed.
Because the design has no control group, its results would describe outcomes among participants who received the study strategy. They would not by themselves estimate the difference between that strategy and an alternative. The sequential treatment phases also do not function as independent comparison groups: participants entered maintenance after induction, and the number at risk differs by phase in the posted safety information.
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.
Induction (docetaxel and carboplatin)
| Stage | Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate) |
|---|---|
| STARTED | 18 |
| COMPLETED | 16 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate) |
|---|---|
| Adverse Event | 1 |
| Death | 1 |
Maintenance (rucaparib)
| Stage | Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate) |
|---|---|
| STARTED | 16 |
| COMPLETED | 0 |
| NOT COMPLETED | 16 |
Reasons for not completing this period:
| Reason | Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate) |
|---|---|
| Adverse Event | 2 |
| Death | 1 |
| Disease Progression | 12 |
| Withdrawal by Subject | 1 |
Analysis population for the primary outcome, as defined in the registry: Overall study cohort
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 | Treatment (Docetaxel, Carboplatin, Rucaparib Camsylate) |
|---|---|---|
| Participants analysed | 18 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 6 |
| Age, Categorical: >=65 years | Participants | 12 |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 18 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 16 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 15 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| PSA at Diagnosis: Participant 1 | ng/mL | 16 |
| PSA at Diagnosis: Participant 2 | ng/mL | 5 |
| PSA at Diagnosis: Participant 3 | ng/mL | 42 |
| PSA at Diagnosis: Participant 4 | ng/mL | 129 |
| PSA at Diagnosis: Participant 5 | ng/mL | 156 |
| PSA at Diagnosis: Participant 6 | ng/mL | 540 |
| PSA at Diagnosis: Participant 7 | ng/mL | 6 |
| PSA at Diagnosis: Participant 8 | ng/mL | 588 |
| PSA at Diagnosis: Participant 9 | ng/mL | 132 |
| PSA at Diagnosis: Participant 10 | ng/mL | 7 |
| Primary treatment (radical prostatectomy or radiation): Prostatectomy | Participants | 5 |
| Primary treatment (radical prostatectomy or radiation): Radiation | Participants | 1 |
| Primary treatment (radical prostatectomy or radiation): Neither | Participants | 12 |
| Prior therapies for castration resistant prostate cancer: 1 Therapy | Participants | 4 |
| Prior therapies for castration resistant prostate cancer: 2 Therapies | Participants | 8 |
| Prior therapies for castration resistant prostate cancer: 3 or more Therapies | Participants | 6 |
| BRCA/ATM/other HR gene mutation status: ATM | participants | 7 |
| BRCA/ATM/other HR gene mutation status: BRCA1 | participants | 3 |
| BRCA/ATM/other HR gene mutation status: BRCA2 | participants | 8 |
| BRCA/ATM/other HR gene mutation status: PALB2 | participants | 1 |
| BRCA/ATM/other HR gene mutation status: FANCA | participants | 1 |
| BRCA/ATM/other HR gene mutation status: CHD1 + SPOP | participants | 1 |
| Clinical Stage at Diagnosis: De novo metastatic disease | Participants | 12 |
| Clinical Stage at Diagnosis: Localized disease at diagnosis | Participants | 6 |
| TNM Stage at Diagnosis: pT3aN0 | Participants | 1 |
| TNM Stage at Diagnosis: pT3bpN1 | Participants | 1 |
| TNM Stage at Diagnosis: T3bN0 | Participants | 1 |
| TNM Stage at Diagnosis: pT3aR0N1 | Participants | 1 |
| TNM Stage at Diagnosis: T2aN1M0 | Participants | 1 |
| TNM Stage at Diagnosis: Unknown | Participants | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Radiographic Progression Free Survival Assessed by Assessment Using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1/Prostate Cancer Working Group 3 (PCWG3) Criteria, measured over From first dose of docetaxel/carboplatin to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, assessed up to 3.75 years..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint was radiographic progression-free survival (rPFS). It measures time from the first dose of docetaxel and carboplatin to the first objective evidence of radiographic progression or death from any cause, whichever occurs first. The registry defines radiographic progression to include confirmed bone disease progression and soft-tissue progression assessed by an investigator using RECIST 1.1 and PCWG3 criteria. The listed timeframe extends from the first dose and is assessed up to 3.75 years.
Time-to-event endpoints are useful when the timing of an event matters and participants may have different lengths of follow-up. A median summarizes the time by which half of the observed population has had the event, subject to the analysis method and follow-up available. A confidence interval expresses statistical uncertainty around an estimate; it is not a range guaranteed to contain the true value.
The registry identifies the endpoint’s intended summary as a median with a 95% confidence interval, but gives no numerical median or interval. The record therefore does not report a numerical rPFS result or its precision. The endpoint definition alone cannot establish how long participants remained free of radiographic progression or death.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central limitation for interpreting efficacy is that the registry record does not report a numerical result for the primary endpoint. Although the endpoint is defined as radiographic progression-free survival and its intended summary is a median with a 95% confidence interval, neither value appears in the record. No conclusion about the observed duration of rPFS, or the precision of an estimate, can be drawn from the endpoint definition alone.
The study enrolled 18 participants and was single-group, with no randomized comparator. Even if an outcome estimate were available, a single-group result would describe outcomes in this cohort rather than directly quantify a treatment effect against another strategy. Differences in patient characteristics, follow-up, or other care cannot be separated from the treatment sequence using a concurrent control in this design. This is a design limitation, not evidence that the regimen did or did not affect outcomes.
The treatment strategy involved induction docetaxel and carboplatin followed by maintenance rucaparib. Outcomes associated with the full sequence could not, from this design alone, isolate the contribution of each component. The phases also occur at different times in the treatment course, and entry into maintenance follows induction. The registry lists 18 participants at risk in the induction safety group and 16 in the maintenance safety group, but these safety counts do not supply an efficacy comparison or explain why the group sizes differ.
The record marks the study terminated, but does not report the reason. Termination status alone does not establish whether the study stopped for safety, feasibility, administrative, efficacy, or another reason. The primary completion date is recorded as 2025-06-04, but the available information does not establish the amount or completeness of follow-up for the primary endpoint.
There are no analysis entries reported. Sponsor-reported hazard ratios are not included in the record, and no numerical primary endpoint result is available to interpret. Thus, an effect estimate, its uncertainty, and any comparison to a threshold cannot be discussed. A planning illustration based on an observed effect is not an observed trial outcome or a substitute for the sponsor’s analysis; no numerical planning result is included in the record addressed.
General statistical context: an estimate is more informative when accompanied by an uncertainty interval and a clear account of censoring, follow-up, and analysis population. A confidence interval describes uncertainty under the analysis assumptions; it does not correct for an uncontrolled design or incomplete reporting. Without the endpoint estimate and analysis details, readers cannot assess the magnitude or precision of the primary outcome from the registry record.
9. Statistical Methods Explained
What does a time-to-event endpoint represent?
Radiographic progression-free survival is a time-to-event outcome. Each participant contributes time from the defined starting point—the first dose of docetaxel and carboplatin—until the first qualifying event, radiographic progression or death from any cause. The earlier event determines the endpoint time. Participants who have not had a recorded event by the end of their observed follow-up are generally treated as censored at their last relevant assessment in standard time-to-event methods. That is a general explanation; the specific censoring rules used for this study are not reported in the registry record.
Time-to-event methods can use information from participants whose follow-up ends before an event is observed, rather than treating them as if their event occurred at the end of observation. Their information is partial: it establishes that the event had not been recorded through the last observed time. Interpretation depends on consistent event definitions, adequate follow-up information, and assumptions about censoring. The registry defines progression criteria but does not report the analysis details needed to assess these assumptions.
What would a median and confidence interval tell readers?
A median time-to-event estimate is a descriptive summary of the event-time distribution. It identifies the point at which the estimated share of participants remaining event-free reaches half, when the data and method permit that point to be estimated. It is not the average event time, and it does not describe every participant’s experience. The registry specifies a median and 95% confidence interval as the primary endpoint summary, but reports no numerical estimate or interval.
In general, a confidence interval communicates uncertainty around an estimate under the statistical method and its assumptions. A narrower interval indicates greater statistical precision than a wider interval, but precision is distinct from validity and from clinical importance. The interval does not account automatically for design limitations, measurement errors, or unreported analyses. Since the numerical interval is not reported in the registry record, precision cannot be assessed for this endpoint.
Why does the absence of a control group matter?
General explanation: a concurrent control group helps distinguish outcomes associated with a treatment strategy from outcomes that might also occur under another strategy or usual care. In a single-group study, observed outcomes can be described, but there is no randomized between-group contrast. The study is recorded as single-group, with allocation listed as NA. The record therefore does not support a randomized comparative effect estimate.
The sequential phases also require careful interpretation. Induction preceded maintenance, so the maintenance group represents participants who reached that phase rather than a separate group assigned at the same starting point. Comparisons between phase-specific counts would not be a randomized comparison. The safety groups report different numbers at risk, but the registry does not explain the participant flow between phases in the information.
What statistical analysis is reported?
The record identifies a median-time primary endpoint and a 95% confidence interval, but does not give the numerical endpoint result or details of the method used to estimate it. It reports no analysis entries. The statistical plan, including any prespecified modeling choices, censoring rules, subgroup analyses, or interim looks, is not reported in the registry record. Those details should not be inferred from the endpoint label.
General explanation: hazard ratios, when reported, compare event rates over time under a model and are not the same as a ratio of median times. Their interpretation depends on the model and assumptions, including whether relative hazards are adequately represented over follow-up. No sponsor-reported hazard ratio is included in the record. It is therefore not possible to characterize a relative time-to-event effect from this record.
Over-dispersion is a general concern in count outcomes when variation exceeds what a simple count model expects; accounting for it can affect standard errors and uncertainty. It is not a reported feature of this primary endpoint, which is a time-to-event measure. No count-model analysis details are reported, so this concept should not be treated as a study-specific finding.
How should planning calculations be distinguished from trial results?
General explanation: a sample-size planning calculation asks how many participants or events might be needed under specified assumptions to detect a chosen effect with a chosen statistical threshold and power. It is a design illustration, not an outcome observed in the trial, and it does not establish the probability that a particular study result is true. The record describes planning illustrations based on fractions of an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. For time-to-event illustrations, the stated quantity is total events; other illustrations are participants per arm.
These assumptions do not change the actual study design: this trial is recorded as single-group, not as a two-arm randomized comparison. The record does not report the numerical planning outputs here, and the primary endpoint result needed to identify an observed effect is also absent. Planning figures therefore cannot be used to claim that the completed study had a particular power or that it observed a particular treatment effect. The protocol’s own sample-size justification is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record does not report a statistical analysis plan describing how multiple outcomes or analyses were handled. It lists one primary endpoint and several secondary outcomes, including overall response rate of measurable disease, PSA nadirs after induction and maintenance, PSA response duration, and time to PSA progression. The record reports six secondary outcome measures, but does not provide results for those outcomes in the information available for this analysis. It also reports no analysis entries.
Multiplicity is the general statistical issue that arises when several hypotheses or outcomes are examined: the chance of at least one apparently unusual finding can increase as the number of tests grows. Prespecified testing sequences or other adjustment approaches can address particular multiplicity concerns, but no such approach is reported in the registry record. It is not appropriate to assume that an adjustment was or was not used.
Missing-data handling and analysis populations are also not reported in the registry record. The available information does not specify an intention-to-treat population, a per-protocol population, rules for incomplete assessments, or how participants without a recorded endpoint event were handled. Such details matter because analysis populations and missingness rules can affect estimates and their uncertainty. They cannot be reconstructed from the enrollment figure or endpoint definition.
The record’s terminated status does not establish why the study ended or whether missing observations resulted from termination. No reason for termination or detailed participant-flow account is reported. Consequently, the completeness of outcome follow-up and the potential influence of missing data cannot be evaluated from this 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 |
|---|---|---|---|
| Induction Phase (Docetaxel and Carboplatin) | 2 | 18 | 11.1% |
| Maintenance Phase (Rucaparib Camsylate) | 1 | 16 | 6.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Induction Phase (Docetaxel and Carboplatin) | 1 of 18 |
| Maintenance Phase (Rucaparib Camsylate) | 1 of 16 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Induction Phase (Docetaxel and Carboplatin) | 18 of 18 |
| Maintenance Phase (Rucaparib Camsylate) | 16 of 16 |
Most frequent serious adverse event terms
| Event term | Organ system | Induction Phase (Docetaxel and Carboplatin) | Maintenance Phase (Rucaparib Camsylate) |
|---|---|---|---|
| Starvation Ketoacidosis | Metabolism and nutrition disorders | 1 of 18 | 0 of 16 |
| Acute Ketoacidosis | Metabolism and nutrition disorders | 1 of 18 | 0 of 16 |
| Intractable Vomiting | Gastrointestinal disorders | 0 of 18 | 1 of 16 |
| Cerebral Venous Sinus Thrombosis | Nervous system disorders | 0 of 18 | 1 of 16 |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 0 of 18 | 1 of 16 |
| Skin ulceration, right foot | Skin and subcutaneous tissue disorders | 0 of 18 | 1 of 16 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Induction Phase (Docetaxel and Carboplatin) | Maintenance Phase (Rucaparib Camsylate) |
|---|---|---|---|
| Fatigue | General disorders | 15 of 18 | 12 of 16 |
| Anemia | Blood and lymphatic system disorders | 11 of 18 | 6 of 16 |
| Nausea | Gastrointestinal disorders | 9 of 18 | 6 of 16 |
| Constipation | Gastrointestinal disorders | 8 of 18 | 6 of 16 |
| Anorexia | Metabolism and nutrition disorders | 7 of 18 | 5 of 16 |
| Diarrhea | Gastrointestinal disorders | 8 of 18 | 3 of 16 |
| Thrombocytopenia | Investigations | 5 of 18 | 4 of 16 |
| Hypomagnesemia | Metabolism and nutrition disorders | 5 of 18 | 3 of 16 |
| Weight loss | Investigations | 2 of 18 | 5 of 16 |
| Rash | Skin and subcutaneous tissue disorders | 4 of 18 | 2 of 16 |
Serious events with the highest arm-level rate: intractable vomiting (6.2%), cerebral venous sinus thrombosis (6.2%), respiratory failure (6.2%), skin ulceration, right foot (6.2%), starvation ketoacidosis (5.6%).
The registry reports safety by treatment phase. In the induction phase, 18 participants were listed at risk for serious adverse events, and 2 were listed as affected. In the maintenance phase, 16 were listed at risk and 1 was listed as affected. The record also lists 1 death in each phase. These are phase-specific registry counts; they should not be added to infer a count of unique people, because the record does not explain whether the same participant could contribute across phases.
The listed serious adverse event terms and percentages are Intractable Vomiting, 6.2%; Cerebral Venous Sinus Thrombosis, 6.2%; Respiratory Failure, 6.2%; Skin ulceration, right foot, 6.2%; Starvation Ketoacidosis, 5.6%; and Acute Ketoacidosis, 5.6%. These are the terms identified in the registry’s serious-event listing. The record does not give further event-level detail here, such as timing, duration, outcome, or attribution to a particular drug.
The phase counts describe reported events in this study, not a controlled comparison of safety between treatments. The record lists 18 participants affected by other adverse events during induction and 16 during maintenance, among the corresponding 18 and 16 at risk. Such counts do not by themselves establish cause, severity for each event, or comparative risk. No causal conclusion should be drawn from the phase-specific figures alone.
12. What the Result Does, and Does Not, Mean
The record describes a phase 2 study of a treatment sequence for metastatic castration-resistant prostate cancer with homologous recombination DNA repair deficiency. It identifies induction docetaxel and carboplatin followed by maintenance rucaparib, and defines radiographic progression-free survival as the primary endpoint. It also reports enrollment of 18 participants, a single-group design, and a terminated status.
The record does not report the numerical primary endpoint result. In particular, it gives no median rPFS or 95% confidence interval. It therefore does not establish the observed time-to-event outcome or its statistical precision. A treatment schedule and endpoint definition are not outcome evidence.
The design also does not provide a randomized comparison with another treatment strategy. Any outcomes from a single group would be descriptive for that cohort and could not, on their own, quantify what would have happened to comparable participants under a different strategy. Since the regimen includes sequential induction and maintenance phases, the study does not isolate the effect of each component.
The registry’s safety counts and serious-event terms are descriptive. They do not establish that a particular drug caused an event or allow a controlled comparison of safety. The stated termination status does not explain why the study ended; a reason is not reported in the registry record.
General statistical context: effect estimates should be interpreted alongside their uncertainty, analysis population, follow-up, and design. A confidence interval describes uncertainty under the chosen analysis, while a control group helps support comparative inference. Neither an intended endpoint nor a planning calculation substitutes for a reported outcome. The information in the registry record supports describing the study design and listed safety figures, but not asserting a numerical efficacy result or a causal treatment effect.
13. Why This Trial Matters Statistically
Statistically, this study illustrates why design, outcome reporting, and interpretation must be considered together. The clinical question concerns a specific sequence—docetaxel and carboplatin induction followed by rucaparib maintenance—in a population described as having metastatic castration-resistant prostate cancer with homologous recombination DNA repair deficiency. Yet the design is single-group, so the outcomes cannot be directly contrasted with outcomes under a concurrent control strategy.
The primary endpoint is time-to-event rather than a simple end-of-treatment measurement. Its definition identifies the origin of follow-up and the events that count, including radiographic progression or death. Clear event definitions are important because different rules for progression assessment or censoring can change the analysis. Although the record specifies RECIST 1.1 and PCWG3 criteria, it does not provide the numerical median, confidence interval, or further analysis details.
The record also demonstrates that registration details and outcome evidence are not interchangeable. A study may have a defined endpoint and an intended summary while the registry record does not report the endpoint estimate. Without that estimate and its uncertainty, readers cannot judge the observed rPFS duration or its precision. The terminated status is another relevant record feature, but without a stated reason it cannot explain the missing numerical result.
Finally, planning illustrations and safety summaries answer different questions from an efficacy analysis. Planning calculations concern assumed study characteristics; safety counts describe reported events by phase. Neither supplies a comparative efficacy estimate. Keeping those roles separate prevents design assumptions or descriptive counts from being mistaken for evidence of a 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.
Several limitations are specific to the information reported for this study. First, the registry record does not include the numerical result for the primary endpoint, despite specifying a median and 95% confidence interval. It also does not report sponsor hazard ratios or analysis entries. The efficacy outcome and its precision therefore cannot be evaluated from the record.
Second, the study is single-group and has no randomized comparator. It can describe outcomes among enrolled participants but cannot establish a comparative effect against another treatment. Because the intervention was sequential, outcomes cannot be attributed separately to induction chemotherapy or maintenance rucaparib using this design alone.
Third, the study is listed as terminated, but the reason is not reported in the registry record. The available information does not establish whether termination affected follow-up or outcome reporting. Participant flow, endpoint follow-up completeness, missing-data rules, and analysis populations are not reported in the registry record, limiting assessment of possible selection or missingness effects.
Fourth, the maintenance-treatment description is truncated, and the record does not provide further details about continuation criteria. The protocol’s sample-size justification, interim analyses, and detailed statistical plan are also not reported in the registry record. No assumptions about these features should be made from the treatment description or endpoint label.
Finally, safety summaries are reported by phase, with different numbers at risk. The registry information does not clarify whether participants contributed to both phases or provide event-level context sufficient for causal attribution. The phase-specific counts should therefore be read descriptively rather than as a controlled comparison.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency — NCT03442556.
- Registry record last updated 2026-08-26; status last verified 2026-08.
- Results first posted 2026-08-26.
- 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
NCT03442556 is a phase 2, single-group study sponsored by the University of Washington. It enrolled 18 participants with metastatic castration-resistant prostate cancer and homologous recombination DNA repair deficiency. The treatment strategy was induction docetaxel and carboplatin followed by maintenance rucaparib camsylate. The study started on 2018-08-24, has a primary completion date of 2025-06-04, and is listed as terminated.
The primary endpoint was radiographic progression-free survival, defined from first dose of docetaxel and carboplatin to radiographic progression or death from any cause. The endpoint was to be summarized as a median with a 95% confidence interval, but no numerical result is reported in the registry record. The record includes phase-specific safety counts and serious adverse event terms, but no randomized comparison. The reason for termination, detailed statistical plan, missing-data handling, and analysis populations are not reported in the registry record.