Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy (NCT02903368), a randomized phase 2 study. The primary outcome is Combined pCR or MRD Rate [Part 1].

2. Clinical Question

This is a comparison of the two neoadjuvant regimens in Part 1, not a comparison of neoadjuvant treatment with no treatment. The registry also describes a separate Part 2 randomization involving AAPL adjuvant therapy and observation, but the primary endpoint concerns the Part 1 neoadjuvant comparison. Results for the Part 2 biochemical progression-free survival endpoint are not reported in the registry record.

3. Trial Design

The registry identifies NCT02903368 as a randomized phase II study in intermediate-high risk prostate cancer undergoing prostatectomy. It lists a parallel-group design and no masking. The registry lists 118 participants enrolled and marks the trial as completed. The recorded start date is 2016-10-19, and the primary completion date is 2022-04-05.

Part 1 compared two neoadjuvant regimens over 6 months. Arm 1A, AAPL, combined abiraterone acetate, apalutamide, leuprolide, and prednisone. Arm 1B, APL, combined abiraterone acetate, leuprolide, and prednisone. Both arm descriptions specify radical prostatectomy after the neoadjuvant treatment period. The registry record does not report the randomization sequence, allocation concealment, or the method used to assign participants.

The primary pathology analysis included 114 participants with prostatectomy assessment, comprising 55 in AAPL and 59 in APL. Four participants who withdrew before prostatectomy were excluded from this assessment. The primary endpoint was a combined pathological response measure, assessed from the prostatectomy specimen at 6 months from the initiation of neoadjuvant therapy.

The record also describes Part 2 as an adjuvant comparison between AAPL therapy and observation. The adjuvant AAPL arm description specifies 12 months of therapy. However, the primary comparison and the posted pathology outcomes concern Part 1. The registry record does not report results for the listed 2-year biochemical progression-free survival outcome in Part 2.

Although the trial is labeled phase II and randomized, its original sample-size justification, target power, planned effect size, and prespecified analysis plan are not reported in the registry record. Masking is listed as none; further details about who knew treatment assignment are not reported in the registry 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.

Before assignment: The part 2 of the study is still in progression and the final data has not been collected

Part 1

Reasons for not completing this period:

Part 2

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 114 patients (55 in AAPL Arm and 59 in APL Arm) had RP pathologic assessment, excluding the four who withdrew prior to RP.

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.

6. Primary Endpoint

The registry lists the primary outcome as Combined pCR or MRD Rate [Part 1], measured over Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy..

The primary endpoint counts participants who achieved either pathological complete response, abbreviated pCR, or minimal residual disease, abbreviated MRD, in the radical prostatectomy specimen. The registry defines pCR as the absence of morphologically identifiable carcinoma in the specimen. It defines MRD as residual tumor measuring ≤ 5 mm. The combined endpoint therefore groups absence of identifiable cancer with a specified small residual tumor measurement.

The endpoint was assessed from prostatectomy specimens at 6 months from the initiation of neoadjuvant therapy. The registry reports 12 participants meeting the combined response definition in each arm: 12 of 55 in AAPL and 12 of 59 in APL. The primary comparison is between these two neoadjuvant treatment groups among participants whose pathology was assessed.

As a general statistical concept, a pathological endpoint can provide a direct measure of tissue findings at surgery, rather than relying only on symptoms or later disease events. Combining pCR and MRD creates a broader response category than pCR alone. It does not, by itself, establish how the pathological finding relates to longer-term outcomes. The registry record does not report evidence validating this combined endpoint as a predictor of later clinical outcomes.

7. Results Posted in the Registry

• Arm 1B: APL Neoadjuvant Therapy (Part 1): 20.3% (12/59) versus 21.8% (12/55) on control; risk difference -1.5 percentage points (95% CI -16.5 to 13.5), risk ratio 0.93 (0.46–1.90); unadjusted two-proportion z-test p = 0.847.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Rate of pCR at RP (Part 1)

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Arm 1B: APL Neoadjuvant Therapy (Part 1): 10.2% (6/59) versus 12.7% (7/55) on control; risk difference -2.6 percentage points (95% CI -14.3 to 9.1), risk ratio 0.80 (0.29–2.23); unadjusted two-proportion z-test p = 0.668.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm 1B: APL Neoadjuvant Therapy (Part 1) and the control. The interval gives the range of effects that remain compatible with the data.

Frequency of Presenting Cribriform at RP (Part 1)

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Arm 1B: APL Neoadjuvant Therapy (Part 1): 0.0% (0/59) versus 1.8% (1/55) on control; risk difference -1.8 percentage points (95% CI -5.3 to 1.7); unadjusted two-proportion z-test p = 0.298.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm 1B: APL Neoadjuvant Therapy (Part 1) and the control. The interval gives the range of effects that remain compatible with the data.

Frequency of Presenting Intraductal Carcinoma at RP (Part 1)

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Arm 1B: APL Neoadjuvant Therapy (Part 1): 32.2% (19/59) versus 27.3% (15/55) on control; risk difference 4.9 percentage points (95% CI -11.8 to 21.7), risk ratio 1.18 (0.67–2.09); unadjusted two-proportion z-test p = 0.565.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm 1B: APL Neoadjuvant Therapy (Part 1) and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the description of pathology and perioperative findings beyond the combined primary response. The registry lists pCR separately, along with specimen findings, surgical margins, PSA before prostatectomy, intra-operative complications, and a later biochemical progression-free survival outcome. Only some of these outcomes have posted results in the record.

For the secondary pathology comparisons with posted estimates and intervals, the intervals include no difference. The observed findings do not provide a consistent, precise pattern that resolves the uncertainty in the primary combined endpoint. They also do not establish that the regimens have equivalent effects across pathology outcomes. The outcomes measure distinct features, so an observed pattern for one should not be assumed to apply to another.

The separate pCR outcome is narrower than the combined pCR or MRD primary definition. It is therefore related to the primary question but does not replace it. The other specimen findings address different aspects of tumor pathology and should be considered complementary rather than interchangeable evidence.

Unadjusted secondary results carry less weight because testing several outcomes can increase the chance of seeing an apparently notable result by chance. These findings may be useful for describing the data and generating further questions, but their interpretation depends on prespecified priorities and multiplicity handling. Such details are not reported in the registry record. Results for the listed Part 2 biochemical progression-free survival outcome are not reported in the registry record, so the secondary data do not establish a longer-term disease-control pattern.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Rate of pCR at RP (Part 1)
• Median of Residual Cancer Burden (RCB) at RP (Part 1)
• Frequency of Presenting Cribriform at RP (Part 1)
• Frequency of Presenting Intraductal Carcinoma at RP (Part 1)
• Frequency of Positive Surgical Margins at RP (Part 1)
• Percent of Participants With Nadir PSA < 0.2 ng/mL Prior to RP (Part 1)
• Frequency of Presenting Intra-operative Complications Following RP (Part 1)
• Biochemical Progression Free Survival (bPFS) Rate at 2 Years Post RP [Part 2]

9. Statistical Interpretation

10. Statistical Methods Explained

For a binary endpoint, each participant is classified as either meeting or not meeting the specified outcome. The primary endpoint is a count of participants meeting the combined pCR or MRD definition. Its arm-specific denominators are the participants whose prostatectomy pathology was assessed. The comparison uses the response proportion in AAPL and the response proportion in APL, then expresses their difference as a risk difference.

What the risk difference means

The posted risk difference is for APL relative to AAPL. A negative value means the observed response proportion was lower in APL; a positive value would mean it was higher. The estimate is -0.015. The interval runs from -0.165 to 0.135, spanning values on both sides of no difference. The p-value is 0.847 and is identified as unadjusted. A p-value measures how compatible the observed data are with a specified no-difference model under the assumptions of the test; it is not the probability that the null hypothesis is true, nor does it quantify clinical importance.

What an interval adds

In general, a confidence interval describes the range of effect estimates compatible with the data under a particular statistical procedure. Its width reflects precision: a wider interval indicates less precision. Here, the interval includes no difference and allows for response differences favoring either group. The registry record does not report the confidence level or the detailed method used to calculate the interval, so those details should not be inferred.

Counts, denominators, and analysis population

The primary comparison includes 55 participants in AAPL and 59 in APL, with 12 responses in each arm. The full enrollment is 118, while the pathology assessment population is 114. These are different denominators because four participants withdrew before prostatectomy and were excluded from the pathology assessment. The registry record does not report an intention-to-treat analysis for this endpoint, the reasons for withdrawal, or an imputation approach for missing pathology results.

As a general statistical principle, analyzing only participants with an observed endpoint can change the balance created by randomization if exclusions are related to assigned treatment or outcome. Whether that occurred cannot be determined from the registry record. The listed analysis population should therefore be kept distinct from the full enrolled population when describing the result.

Unadjusted comparisons and secondary outcomes

The registry lists unadjusted p-values for posted comparisons. An unadjusted p-value does not account for the number of outcomes or comparisons tested. When many outcomes are examined, the chance of at least one apparently unusual result can increase. General approaches include prespecifying a primary outcome, adjusting for multiple testing, or treating secondary findings as exploratory. The registry record does not report which approach, if any, was planned for this trial.

The secondary outcomes include a separate pCR count and specimen findings such as cribriform and intraductal carcinoma. These are binary counts, so the observed result is a number of participants with the finding among those assessed. Other listed secondary measures include residual cancer burden, surgical margins, nadir PSA, intra-operative complications, and biochemical progression-free survival. Results for all listed secondary outcomes are not present in the registry record; the posted secondary findings should not be interpreted as if they form a complete prespecified testing family.

General note on over-dispersion

Over-dispersion occurs when observed variability is greater than a statistical model assumes. It matters in outcomes such as clustered counts or repeated measurements because an ordinary model can then understate uncertainty. The primary endpoint is a binary participant count, and no over-dispersion parameter is reported. The registry record does not report a model-based adjustment for over-dispersion, and there is no basis in the posted endpoint description for assuming that such an adjustment was used.

The registry lists no reported analysis entries for the displayed secondary outcomes. The numerical comparisons should therefore be read as posted comparisons, not as evidence that a particular adjustment, covariate model, or planned statistical procedure was used. Details of covariate adjustment, stratification, interim analyses, and handling of protocol deviations are not reported in the registry record.

11. Confidence Intervals and Precision

The primary risk-difference estimate is -0.015, with an interval from -0.165 to 0.135. Because the interval includes zero, the posted data are compatible with no difference as well as with differences favoring either arm. The point estimate alone should not be treated as a precise measure of the underlying contrast.

The same number of participants, 12, met the combined response definition in both arms, but the arm denominators differ: 55 in AAPL and 59 in APL. The interval captures uncertainty in the comparison and is broad enough that small observed differences do not settle the direction or magnitude of the underlying effect. The registry record does not state the confidence level or interval calculation method.

As a general concept, precision depends on both the amount of information in the data and the variability of the outcome. A binary endpoint with relatively few responses can yield substantial uncertainty, particularly when the number of assessed participants is limited. This does not mean the trial has no information; it means its estimate should be read alongside the interval rather than as a definitive point value.

The interval is not a range containing a known fixed percentage of individual outcomes. It describes uncertainty about the group-level contrast under the method used to calculate it. It also does not account for every possible limitation, such as missing pathology assessments, unreported analysis choices, or multiplicity. Those considerations affect how strongly the result can support broader conclusions.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size planning figures are participants per arm, not total participants or total events. They are illustrations based on the observed effect, not the trial's original design justification. The registry record does not report the trial's own original sample-size assumptions.

The planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers the stated fractions of the observed effect: 100%, 75%, and 50%. The 80% power column represents the number of participants per arm that the illustration estimates would be needed to have an 80% chance of detecting the specified effect under those assumptions, if that effect were the true one. The 90% power column describes the corresponding planning target for a 90% chance.

Smaller effects require more participants per arm to detect with the same power under the stated assumptions. This is why the illustrated requirements increase as the assumed effect moves from the full observed effect to smaller fractions. The displayed planning values are illustrations, not observed power.

These calculations do not show that the trial was designed with these assumptions, and they do not turn the observed comparison into a reliable estimate of a future trial's needs. In particular, planning around an effect estimated from a modest trial can be unstable. The original sample-size justification, intended primary comparison assumptions, and any allowance for withdrawals are not reported in the registry record.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.218; treatment proportion p₁ = 0.203; average p̄ = 0.211.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.5768 = 1.1305.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.5767 = 0.4854.
4. n = (1.1305 + 0.4854)² / (-0.0148)² = 11,933.8, rounded up to 11,934 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.218181818181818                          # control proportion
p1 <- 0.203389830508475                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(2903368)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 11,934 (80% power), 15,976 (90% power)
 75% of observed effect: n per arm = 21,353 (80% power), 28,585 (90% power)
 50% of observed effect: n per arm = 48,349 (80% power), 64,725 (90% power)
power.prop.test: 11933.8 
Simulated power at n = 11,934 per arm: 0.801 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary endpoint and multiple secondary outcomes. Testing more than one outcome can increase the chance of at least one result appearing statistically notable by chance. A multiplicity plan may specify which outcome is confirmatory, adjust inference across tests, or identify secondary analyses as exploratory. The registry record does not report a multiplicity adjustment or a hierarchy for interpreting the secondary endpoints. The posted secondary p-values are unadjusted.

The primary endpoint was assessed among 114 participants with prostatectomy pathology, rather than all 118 enrolled participants. The record says four participants withdrew before prostatectomy and were excluded from the pathological assessment. It does not report why they withdrew, whether the withdrawals differed by arm, what their outcomes might have been, or whether sensitivity analyses assessed the effect of their exclusion. The primary result therefore describes the assessed group, and the effect of missing pathology data cannot be evaluated from the registry record.

The registry record does not report whether the primary analysis followed an intention-to-treat principle, how protocol deviations were handled, whether covariates were adjusted for, or whether any interim analyses took place. The original statistical analysis plan and original sample-size justification are not reported in the registry record. These omissions mean that readers cannot verify from the record whether the posted comparisons follow prespecified procedures.

Randomization is listed, but details of sequence generation and allocation concealment are not reported in the registry record. Masking is listed as none. These design details matter when assessing possible sources of bias, but their absence from the record does not establish that a particular procedure was or was not used. Interpretation should remain limited to the information documented for the trial.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hypertension (8.5%), alanine aminotransferase increased (3.4%), aspartate aminotransferase increased (3.4%), acute coronary syndrome (2.7%), cardiac disorders - other, specify (2.7%).

The serious adverse event figures are counts among the participants listed as at risk in each group. In Part 1, the registry records 8 serious adverse events among 59 at risk in the AAPL group and 5 among 59 at risk in the APL group. In Part 2, it records 4 among 37 at risk in the AAPL adjuvant group and 0 among 38 at risk in the observation group. No deaths are listed in any of these groups.

These figures are descriptive counts. The registry record does not report a formal comparative safety analysis, adjustment for differences in exposure, or a complete account of event timing and duration. The Part 1 and Part 2 groups belong to separate portions of the trial and should not be combined into a single treatment comparison. The top listed serious event term is hypertension, recorded as 8.5%; other listed terms include alanine aminotransferase increased and aspartate aminotransferase increased, each recorded as 3.4%.

Serious adverse event counts do not describe all adverse events or establish comparative safety on their own. The registry record's serious-event summary should be interpreted as a report of recorded events, not as a complete assessment of possible harms.

16. What the Result Does, and Does Not, Mean

The primary result describes the proportion of assessed participants whose prostatectomy specimen met the registry's combined pCR or MRD definition. The observed counts were 12 in each arm, among 55 assessed in AAPL and 59 in APL. The estimated risk difference is close to zero, but its interval is wide and spans effects in either direction. The result is therefore inconclusive about the comparative effect of these two neoadjuvant regimens on this pathological endpoint.

It does not demonstrate equivalence. A finding of no statistically significant difference is not the same as evidence that two treatments have the same effect. An equivalence or non-inferiority conclusion requires an appropriate design, a prespecified margin, and a corresponding analysis; these are not reported in the registry record.

The result also does not compare either regimen with no neoadjuvant treatment. Both Part 1 groups received combination therapy. Nor does the pathology outcome alone establish an effect on survival, recurrence, quality of life, or other patient outcomes. The registry lists a biochemical progression-free survival endpoint for Part 2, but results for that endpoint are not reported in the registry record.

The pathology comparison excludes four participants who withdrew before prostatectomy. Without information about their reasons for withdrawal or outcomes, the extent to which this affects the comparison cannot be determined. The findings should therefore be understood as applying to the participants with pathology assessment, not automatically to every participant enrolled.

More broadly, the trial's randomized phase II design and posted results provide a comparison of two regimens on the recorded endpoints. They do not establish how the findings generalize beyond the trial population or whether either regimen should be chosen in practice. The record does not report the full analysis plan or the original design assumptions needed to assess all confirmatory claims.

17. Why This Trial Matters Statistically

This trial illustrates how a randomized clinical comparison can produce a small point estimate while leaving substantial uncertainty. The primary groups had the same number of recorded responses, but the interval around the risk difference extends in both directions. Statistical interpretation therefore requires attention to both the estimate and its precision, rather than treating a p-value alone as a verdict.

It also highlights the difference between a broad combined endpoint and its component outcomes. The primary measure includes both pCR and MRD, while a listed secondary measure counts pCR alone. That distinction affects the clinical and statistical meaning of the result: the broader outcome is not interchangeable with complete response alone. The registry defines both categories, allowing the endpoint to be read in context.

The record also demonstrates why analysis populations matter. The primary pathology result includes 114 assessed participants, while enrollment was 118. Explicitly identifying the four withdrawals prevents the assessed denominator from being mistaken for the full randomized group, while the missing details about those withdrawals leave a genuine limitation.

Finally, the trial has multiple listed endpoints, but the record does not document multiplicity handling or the full analysis plan. The unadjusted secondary findings should consequently be interpreted cautiously. These features are central statistical considerations: endpoint definition, analysis population, precision, and multiplicity all influence what conclusions the results can support.

18. 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 primary assessment excludes four participants who withdrew before prostatectomy. Reasons for withdrawal, allocation-specific withdrawal details, and sensitivity analyses are not reported in the registry record. The result therefore reflects participants with pathological assessment, and the possible influence of missing assessments remains unknown.

The registry reports a randomized, unmasked, parallel phase II design, but does not describe sequence generation, allocation concealment, or the original sample-size justification. The original analysis plan, including any planned adjustment, interim analyses, or handling of deviations, is also not reported in the registry record. This limits assessment of whether the posted comparisons were prespecified and how they were intended to be interpreted.

The primary endpoint is a combined pathology measure at prostatectomy. It captures a specified tissue finding at a fixed assessment point, but the record does not report validation of this endpoint as a surrogate for later clinical outcomes. The listed Part 2 biochemical progression-free survival outcome has no results reported in the registry record, leaving the posted pathology findings without a corresponding longer-term result in this record.

Several secondary outcomes are listed, while only some have posted results. The available secondary comparisons use unadjusted p-values, and the record does not report how multiplicity was handled. Safety information is also presented descriptively; no formal comparative analysis is reported. These limitations restrict conclusions about both secondary efficacy findings and comparative safety.

The trial compares two active neoadjuvant combinations, so its primary comparison cannot answer how either regimen compares with no neoadjuvant therapy. Generalizability beyond the enrolled population is not established by the registry record.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy — NCT02903368.
• Registry record last updated 2025-06-13; status last verified 2025-06.
• Results first posted 2021-09-05.
• 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.

22. Record Summary

NCT02903368 is a completed randomized, unmasked, parallel phase II trial in intermediate-high risk prostate cancer undergoing prostatectomy. The registry lists 118 enrolled participants and a primary pathology assessment at 6 months from initiation of neoadjuvant therapy.

The primary endpoint combined pathological complete response and minimal residual disease in the prostatectomy specimen. The record reports 12 responses among 55 assessed participants in AAPL and 12 among 59 in APL. The risk-difference interval includes no difference, and the unadjusted p-value is 0.847.

The record also lists secondary pathology, perioperative, and progression outcomes, but results are not posted for every listed endpoint. Four participants withdrew before prostatectomy and were excluded from the primary pathology assessment. The original sample-size justification, full statistical analysis plan, and multiplicity approach are not reported in the registry record.