Prostatic Neoplasms
Conditions
Brief summary
This is a prospective, multicenter, open-label, randomized phase III study in participants at high risk of recurrent prostate cancer after radical prostatectomy. The study will investigate * Treatment with docetaxel (TAXOTERE®) every three weeks (q3w) plus leuprolide acetate (ELIGARD®) versus leuprolide acetate alone (ELIGARD®) * Immediate treatment following prostatectomy versus deferred treatment at the time of relapse Using a 2x2 factorial design participants will therefore be randomized to * Immediate adjuvant treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) * Immediate adjuvant treatment with leuprolide acetate alone (hormonal therapy) * Deferred treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) * Deferred treatment with leuprolide acetate alone (hormonal therapy) Primary Objective: * The primary objective of the study is to compare progression-free survival using a 2x2 factorial design Secondary Objectives: * To compare the 5-year overall, cancer-specific and metastasis-free survival after systemic treatment between the groups * To compare the safety and tolerability between Docetaxel in combination with leuprolide acetate and leuprolide acetate alone. * To evaluate quality of life as measured by the FACT-P questionnaire. Originally, 1696 participants were planned in the study (with 424 participants randomized to each arm). However, only a total of 211 participants completed the randomization procedure as of 26 September 2007. Thus, sanofi-aventis, in accordance with the Steering Committee, decided to stop the participant recruitment as of 26 September 2007. Participants who had already signed their Informed Consent (IC) before September 26, 2007 were allowed to enter the randomization if they met eligibility criteria. The final revised number of planned participants to be randomly assigned to the 4 treatment arms was 250, and 228 participants were actually randomized. The final sample size did not allow all the statistical analyses to be conducted on efficacy data. Therefore, the protocol was amended to reflect the change in the plans for statistical analysis. The study was underpowered to serve as the basis for drawing conclusions regarding efficacy and quality of life (QoL) endpoints.
Detailed description
The study consisted of the following: * Randomization of eligible participants within 120 days of prostatectomy * For participants assigned to immediate therapy, a treatment period up to 18 months within 8 days of randomization * For participants assigned to deferred treatment, a treatment period up to 18 months after evidence of progression prior to December 2010. Participants who did not progress before December 2010 were withdrawn from the study.
Interventions
DRUGDocetaxel (TAXOTERE®) Chemotherapy
75 mg/m\^2 docetaxel administered intravenously over 1 hour on Day 1 every three weeks (q3w) for 6 cycles. The first cycle was to be administered within 8 days after randomization. Corticosteroid pre-medication was mandatory. The following schedule was recommended - 8 mg Dexamethasone orally for 6 doses given - the night before chemotherapy, the morning of chemotherapy, 1 hour before docetaxel infusion, the night of chemotherapy, the morning of the day after chemotherapy and the night of the day after chemotherapy.
DRUGLeuprolide acetate ( ELIGARD®) Hormonal Therapy
22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 8 days after randomization.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants who met all of the following criteria were considered for enrollment into the study. * Pathologically confirmed adenocarcinoma of the prostate based on central pathology review. All other variants are excluded * Randomization should occur less than 120 days after prostatectomy AND lymphadenectomy. * A predicted probability of 5-year freedom from progression ≤ 60%, as determined by the postoperative nomogram developed by M. Kattan. * Bone-scan without evidence of metastasis (within 6 months of randomization) * Chest x-ray without evidence of metastasis (within 6 months of randomization) * Abdominal computed tomography (CT) Scan without evidence of metastasis (within 6 months of randomization) * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * Hematology evaluation within 2 weeks prior to randomization: * Neutrophils ≥ 2,000/mm3 * Hemoglobin ≥ 10 g/dL * Platelets ≥ 100,000/mm3 * Hepatic and renal function evaluation within 2 weeks prior to randomization: * Serum creatinine ≤1.5 × Upper normal limit (UNL) for the institution. If serum creatinine is \> 1.5 × UNL, calculate creatinine clearance (should be ≥ 60ml/minute). * Total serum bilirubin ≤ UNL for the institution. Participants with Gilbert's syndrome may be eligible if indirect serum bilirubin levels at the time of randomization and, at least 6 month prior to randomization, confirm this condition (i.e. elevated indirect serum bilirubin). * Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamic pyruvic transaminase (SGPT) ≤ 1.5 × institutional UNL if alkaline phosphatase is ≤ UNL OR * alkaline phosphatase ≤ 5 × UNL if SGOT and SGPT are ≤ UNL * Prostate Specific Antigen (PSA) evaluation within 9 months prior to prostatectomy. However, a 120-day timeframe is recommended * Post operative PSA necessary for eligibility is defined as a level ≤ 0.2ng/mL using a standard assay at least 30 days after radical prostatectomy and within 7 days prior to randomization. Note that randomization should occur within 120 days after radical prostatectomy * Serum testosterone ≥ 150ng/dL within 6 months prior to randomization.
Exclusion criteria
Participants presenting with any of the following will not be included in the study. * Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy. * Prior radiation therapy. * Participants who received, are receiving or scheduled to receive post-operative radiotherapy. * Participants taking alternative therapies for cancer must stop taking these therapies prior to randomization. Alternative therapies are not allowed during the treatment or follow-up portions of the study. This includes (but is not limited to) alternative therapies such as : * PC-SPES (all types) * 5-alpha reductase inhibitors * Bisphosphonates are to be stopped prior to randomization and are not allowed during the study. * Chronic treatment with corticosteroids unless initiated \> 6 months prior to study entry and at low dose ( ≤ 20 mg methylprednisolone per day or equivalent). * History of a malignancy other than prostate cancer. Exceptions to these criteria include: * participants with adequately treated non-melanoma skin cancers, and * participants with a history of another malignancy that was curatively treated (including participants with superficial bladder cancer) and who have not had evidence of disease for a minimum of 5 years. * Peripheral neuropathy ≥ Grade 2. * Electrocardiogram (ECG) with significant abnormalities (as determined by the investigator) within 90 days prior to randomization. * Participants who are medically unstable, including but not limited to active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, interstitial lung disease, inflammatory bowel disease, uncontrolled angina, uncontrolled hypercalcemia, uncompensated congestive heart failure, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome. * Participants with history of hypersensitivity to polysorbate 80. * Participants with a known history of viral hepatitis (B, C). The above information was not intended to contain all considerations relevant to potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression | from the date of surgery up to 3 years after randomization of the last participant | PFS is the interval from the date of surgery to date of progression. The date of progression was the earlier of * first PSA increase to ≥ 0.4 ng/mL confirmed within two weeks * date of the nadir, if PSA nadir did not reach \< 0.4 ng/mL (for deferred arm) * first radiological/ histological evidence of tumor progression * death. Median PFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Median PFS could not be estimated. Reported is the number of participants with disease progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Overall Survival (OS) | from the date of surgery up to 3 years after randomization of the last participant | Overall survival (OS) was the time interval from the date of surgery to the date of death due to any cause. Median OS was to be estimated using Kaplan-Meier Curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Moreover, median OS could not be estimated. Reported is the number of participants who died from any cause. |
| Median Cancer-specific Survival (CSS) | from the date of surgery up to 3 years after randomization of the last participant | The CSS was the time from the date of surgery to the date of death due to prostate cancer. Median CSS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median CSS was not estimated. |
| Median Metastasis-free Survival (MFS) | from the date of surgery up to 3 years after randomization of the last participant | MFS was the interval from the date of surgery to the date of the first clinical evidence of metastasis after treatment initiation. Metastasis was evaluated by a physical exam or radiologically on bone scan or CT scan. Local (palpable) progression, documented histologically or by imaging techniques was considered evidence of progression. Median MFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median MFS was not estimated. |
| To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire | from 30 days before randomization (baseline) and 18 months after treatment initiation (for change from baseline) | The 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 QoL with fewer symptoms. A score of 156 represents the best outcome. Note: Enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn due to the low sample size. |
| Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | from treatment initiation up to 19 months after treatment initiation | Number of participants with treatment-emergent adverse events (TEAE). A TEAE was as any adverse event that occurred or worsened during the on-treatment period, which was the period from the day of first infusion of study treatment until 30 days after the last infusion of study treatment. |
Countries
Australia, Austria, Brazil, Canada, France, Germany, India, Israel, Italy, Mexico, Netherlands, Poland, Russia, South Africa, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
Originally, the study was planned for 1696 participants to be randomized. However, enrollment was not met and in September 2007, the Steering Committee decided to stop recruitment. Only participants who had signed Informed Consent by then and met eligibility criteria were randomized. 228 participants were randomized to this study.
Participants by arm
| Arm | Count |
|---|---|
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) Participants administered 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy. | 55 |
| Leuprolide Acetate - Immediate Treatment (I-HT) Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy. | 55 |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m\^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months. | 56 |
| Leuprolide Acetate - Deferred Treatment (D-HT) Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months. | 62 |
| Total | 228 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 1 | 0 |
| Overall Study | chemotherapy not completed (cycle 6) | 1 | 0 | 0 | 0 |
| Overall Study | Did not receive any study medication | 5 | 4 | 36 | 45 |
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 0 |
| Overall Study | Participant did not wish to continue | 3 | 2 | 1 | 0 |
| Overall Study | Progressive disease | 0 | 0 | 1 | 0 |
| Overall Study | Undefined | 0 | 1 | 1 | 4 |
Baseline characteristics
| Characteristic | Total | Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | Leuprolide Acetate - Immediate Treatment (I-HT) | Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | Leuprolide Acetate - Deferred Treatment (D-HT) |
|---|---|---|---|---|---|
| Age Continuous | 61.9 years STANDARD_DEVIATION 7.2 | 61.2 years STANDARD_DEVIATION 7.4 | 61.6 years STANDARD_DEVIATION 7 | 62.1 years STANDARD_DEVIATION 7 | 62.9 years STANDARD_DEVIATION 7.5 |
| Age, Customized <65 years | 141 participants | 37 participants | 34 participants | 35 participants | 35 participants |
| Age, Customized >=65 years | 87 participants | 18 participants | 21 participants | 21 participants | 27 participants |
| Race/Ethnicity, Customized Asian/Oriental | 5 participants | 0 participants | 1 participants | 4 participants | 0 participants |
| Race/Ethnicity, Customized Black | 18 participants | 6 participants | 3 participants | 7 participants | 2 participants |
| Race/Ethnicity, Customized Multiracial | 2 participants | 0 participants | 0 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Other | 4 participants | 1 participants | 2 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 199 participants | 48 participants | 49 participants | 43 participants | 59 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 228 Participants | 55 Participants | 55 Participants | 56 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 47 / 50 | 48 / 51 | 19 / 20 | 13 / 17 |
| serious Total, serious adverse events | 12 / 50 | 8 / 51 | 5 / 20 | 2 / 17 |
Outcome results
Primary
Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression
PFS is the interval from the date of surgery to date of progression. The date of progression was the earlier of * first PSA increase to ≥ 0.4 ng/mL confirmed within two weeks * date of the nadir, if PSA nadir did not reach \< 0.4 ng/mL (for deferred arm) * first radiological/ histological evidence of tumor progression * death. Median PFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Median PFS could not be estimated. Reported is the number of participants with disease progression.
Time frame: from the date of surgery up to 3 years after randomization of the last participant
Population: Intent-to-treat (ITT) population: all randomized participants, regardless of whether or not they received any study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression | 10 participants |
| Leuprolide Acetate - Immediate Treatment (I-HT) | Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression | 14 participants |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression | 9 participants |
| Leuprolide Acetate - Deferred Treatment (D-HT) | Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression | 8 participants |
Secondary
Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)
Number of participants with treatment-emergent adverse events (TEAE). A TEAE was as any adverse event that occurred or worsened during the on-treatment period, which was the period from the day of first infusion of study treatment until 30 days after the last infusion of study treatment.
Time frame: from treatment initiation up to 19 months after treatment initiation
Population: Safety population: all randomized participants who received any study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with a drug-related AE | 47 participants |
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with any adverse event (AE) | 47 participants |
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with any serious adverse event (SAE) | 12 participants |
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with an SAE resulting in death | 0 participants |
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with a drug-related SAE | 6 participants |
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with AE leading to discontinue all study therapy | 2 participants |
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with AE leading to chemotherapy discontinuation | 1 participants |
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with AE leading to chemotherapy dose reduction | 5 participants |
| Leuprolide Acetate - Immediate Treatment (I-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with AE leading to discontinue all study therapy | 0 participants |
| Leuprolide Acetate - Immediate Treatment (I-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with a drug-related SAE | 0 participants |
| Leuprolide Acetate - Immediate Treatment (I-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with any serious adverse event (SAE) | 8 participants |
| Leuprolide Acetate - Immediate Treatment (I-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with AE leading to chemotherapy dose reduction | NA participants |
| Leuprolide Acetate - Immediate Treatment (I-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with any adverse event (AE) | 48 participants |
| Leuprolide Acetate - Immediate Treatment (I-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with a drug-related AE | 43 participants |
| Leuprolide Acetate - Immediate Treatment (I-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with an SAE resulting in death | 0 participants |
| Leuprolide Acetate - Immediate Treatment (I-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with AE leading to chemotherapy discontinuation | NA participants |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with any serious adverse event (SAE) | 5 participants |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with an SAE resulting in death | 0 participants |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with a drug-related AE | 18 participants |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with a drug-related SAE | 2 participants |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with AE leading to discontinue all study therapy | 1 participants |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with AE leading to chemotherapy dose reduction | 2 participants |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with any adverse event (AE) | 19 participants |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with AE leading to chemotherapy discontinuation | 1 participants |
| Leuprolide Acetate - Deferred Treatment (D-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with any serious adverse event (SAE) | 2 participants |
| Leuprolide Acetate - Deferred Treatment (D-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with a drug-related AE | 10 participants |
| Leuprolide Acetate - Deferred Treatment (D-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with an SAE resulting in death | 0 participants |
| Leuprolide Acetate - Deferred Treatment (D-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with AE leading to chemotherapy discontinuation | NA participants |
| Leuprolide Acetate - Deferred Treatment (D-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with a drug-related SAE | 0 participants |
| Leuprolide Acetate - Deferred Treatment (D-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with AE leading to chemotherapy dose reduction | NA participants |
| Leuprolide Acetate - Deferred Treatment (D-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with any adverse event (AE) | 14 participants |
| Leuprolide Acetate - Deferred Treatment (D-HT) | Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE) | with AE leading to discontinue all study therapy | 0 participants |
Secondary
Median Cancer-specific Survival (CSS)
The CSS was the time from the date of surgery to the date of death due to prostate cancer. Median CSS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median CSS was not estimated.
Time frame: from the date of surgery up to 3 years after randomization of the last participant
Population: Based on a protocol amendment, analysis for Median CSS was not to be performed as the study was underpowered.
Secondary
Median Metastasis-free Survival (MFS)
MFS was the interval from the date of surgery to the date of the first clinical evidence of metastasis after treatment initiation. Metastasis was evaluated by a physical exam or radiologically on bone scan or CT scan. Local (palpable) progression, documented histologically or by imaging techniques was considered evidence of progression. Median MFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Therefore, based on a protocol amendment, median MFS was not estimated.
Time frame: from the date of surgery up to 3 years after randomization of the last participant
Population: Based on a protocol amendment, analysis for Median MFS was not to be performed as the study was underpowered.
Secondary
Median Overall Survival (OS)
Overall survival (OS) was the time interval from the date of surgery to the date of death due to any cause. Median OS was to be estimated using Kaplan-Meier Curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Moreover, median OS could not be estimated. Reported is the number of participants who died from any cause.
Time frame: from the date of surgery up to 3 years after randomization of the last participant
Population: Intent-to-treat (ITT) population: all randomized participants, regardless of whether or not they received any drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | Median Overall Survival (OS) | 0 participants |
| Leuprolide Acetate - Immediate Treatment (I-HT) | Median Overall Survival (OS) | 2 participants |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | Median Overall Survival (OS) | 1 participants |
| Leuprolide Acetate - Deferred Treatment (D-HT) | Median Overall Survival (OS) | 1 participants |
Secondary
To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire
The 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 QoL with fewer symptoms. A score of 156 represents the best outcome. Note: Enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn due to the low sample size.
Time frame: from 30 days before randomization (baseline) and 18 months after treatment initiation (for change from baseline)
Population: QoL population: The subset of randomized participants who had an evaluable baseline questionnaire and at least one evaluable post-baseline questionnaire. A baseline QoL questionnaire was considered evaluable if it was filled out within 30 days prior to randomization, and no later than the date of randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire | Baseline | 124.0 score on a scale | Standard Deviation 6 |
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire | Change from Baseline (N=33, N=41, N=12, N=10) | 0.7 score on a scale | Standard Deviation 12.6 |
| Leuprolide Acetate - Immediate Treatment (I-HT) | To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire | Change from Baseline (N=33, N=41, N=12, N=10) | 1.7 score on a scale | Standard Deviation 17.2 |
| Leuprolide Acetate - Immediate Treatment (I-HT) | To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire | Baseline | 121.5 score on a scale | Standard Deviation 17.8 |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire | Baseline | 114.7 score on a scale | Standard Deviation 13.9 |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire | Change from Baseline (N=33, N=41, N=12, N=10) | 6.7 score on a scale | Standard Deviation 15.9 |
| Leuprolide Acetate - Deferred Treatment (D-HT) | To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire | Baseline | 119.7 score on a scale | Standard Deviation 15.8 |
| Leuprolide Acetate - Deferred Treatment (D-HT) | To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire | Change from Baseline (N=33, N=41, N=12, N=10) | 6.1 score on a scale | Standard Deviation 18.9 |