Median Progression-Free Survival (PFS) in Intent-to-treat (ITT) Population
| Group | Value (months) |
|---|---|
| Docetaxel+Leuprolide+Bicalutamide | 25.4 |
| Leuprolide+Bicalutamide | 23.3 |
Trial · Interventional
TerminatedPhase 3Results postedRegistry dataShort name Rising PSA
This trial was stopped early.
Reason given at the registry: Company decision to discontinue the study, not due to any safety or efficacy concerns
Results were posted for this trial.
United States, Belgium, Canada, Czechia, Germany, Lithuania, Poland, Slovakia, Spain
1 trial · 1 stopped early · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The primary objective was to evaluate and compare the efficacy of androgen deprivation with or without docetaxel as determined by the median progression free survival (PFS) over the period of 18-month therapy and at least 18-month follow-up. The secondary objectives were: * To assess cancer specific survival; * To compare overall survival between the 2 treatment groups; * To evaluate patient-reported outcomes including quality of life, fatigue, and sexual functioning as measured by 3 different assessments.
Experimental
Docetaxel+Leuprolide+Bicalutamide
Participants received docetaxel 75 milligram per square meter (mg/m\^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
Active comparator
Leuprolide+Bicalutamide
Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
Outcomes the sponsor listed as primary.
Median Progression-Free Survival (PFS) in Intent-to-treat (ITT) Population
Time frame · Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60
PFS was the time from randomization to the date of first documented prostate specific antigen (PSA) progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. PSA progression was determined as: a) During treatment period: a 50 percent (%) increase from baseline, which was confirmed by a second value; b) During follow-up: detectable PSA (defined as PSA greater than or equal to 0.05 nanogram per millimeter \[ng/mL\]), which was confirmed by consecutive observation (not less than 2 weeks apart). Median PFS was estimated using the Kaplan-Meier method.
Progression-Free Survival (PFS) Rate at Month 36 in ITT Population
Time frame · Month 36
PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method.
Median Progression-Free Survival (PFS) in Testosterone Specific Evaluable Population
Time frame · Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60
PFS was the time from randomization to the date of first documented PSA progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.
Progression-Free Survival (PFS) Rate at Month 36 in Testosterone Specific Evaluable Population
Time frame · Month 36
PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method.
Overall Survival (OS): Number of Participants Who Died (All Cause)
Time frame · Randomization until death due to any cause, assessed up to Month 60
The OS was the time interval from the date of randomization to the date of death due to any cause. OS was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from any cause.
Cancer-Specific Survival: Number of Participants Who Died (Cancer-Specific)
Time frame · Randomization until death due to prostate cancer, assessed up to Month 60
The cancer-specific survival was the time from the date of randomization to the date of death due to prostate cancer. Cancer-specific survival was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from prostate cancer.
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at End of Treatment (EOT)
Time frame · Baseline, EOT (up to Month 18)
FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms. A score of 156 represents the best outcome.
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index (TOI) Score at EOT
Time frame · Baseline, EOT (up to Month 18)
Physical well-being, functional well-being, and prostate cancer concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Index Score at EOT
Time frame · Baseline, EOT (up to Month 18)
MAF scale consists of 16-items to measure 4 dimensions of fatigue during past week: severity (Item 1-2), distress (Item 3), degree of interference in activities of daily living (Item 4-14), and timing (Item 15-16). Item 1-14 are scored on a numeric rating scale from 1 to 10, where higher score indicate more severity/distress/interference. Item 15-16 had multiple choice responses (4 responses each). Scale Index was calculated using Item 1-15, in following steps: 1) Item 15 score converted to 1-10 scale by multiplying the score with 2.5; 2) Average score was calculated from Item 4-14; 3) Finally scale index was calculated by adding Items 1, 2, 3 scores with average score from step 2 and converted score of Item 15 from step 1. Total MAF scale index score ranges 1 (no fatigue) to 50 (severe fatigue).
Change From Baseline in Erectile Function Domain of International Index of Erectile Function (EF-IIEF) Total Score at EOT
Time frame · Baseline, EOT (up to Month 18)
EF-IIEF is a 6-item erectile function domain of IIEF. It consists of Question 1, 2, 3, 4, 5, and 15 of IIEF questionnaire. 5 questions are scored from 0 (no activity) to 5 (very high activity) and 1 question is scored from 1 (very low activity) to 5 (very high activity). Total EF-IIEF score ranges from 1 to 30, where higher score indicates high activity.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (months) |
|---|---|
| Docetaxel+Leuprolide+Bicalutamide | 25.4 |
| Leuprolide+Bicalutamide | 23.3 |
| Group | Value (percent chance of being progression-free) |
|---|---|
| Docetaxel+Leuprolide+Bicalutamide | 15.5 |
| Leuprolide+Bicalutamide | 8.6 |
| Group | Value (months) |
|---|---|
| Docetaxel+Leuprolide+Bicalutamide | 25.7 |
| Leuprolide+Bicalutamide | 24.7 |
| Group | Value (participants) |
|---|---|
| Docetaxel+Leuprolide+Bicalutamide | 4 |
| Leuprolide+Bicalutamide | 11 |
| Group | Value (participants) |
|---|---|
| Docetaxel+Leuprolide+Bicalutamide | 2 |
| Leuprolide+Bicalutamide | 3 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Docetaxel+Leuprolide+Bicalutamide | 121.4 | 18.32 |
| Leuprolide+Bicalutamide | 119.6 | 17.95 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Docetaxel+Leuprolide+Bicalutamide | 82.1 | 12.58 |
| Leuprolide+Bicalutamide | 80.4 | 12.52 |
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Docetaxel+Leuprolide+Bicalutamide | 16.4 | 7.33 |
| Leuprolide+Bicalutamide | 16.6 | 7.93 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Docetaxel+Leuprolide+BicalutamideParticipants received docetaxel 75 milligram per square meter (mg/m\^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. | – | 49 / 196 | 185 / 196 |
| Leuprolide+BicalutamideParticipants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. | – | 20 / 204 | 139 / 204 |
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