Prostatic NeoplasmsPhase 3Rising PSANCT00514917
A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)
A Phase 3 study testing Docetaxel, Leuprolide and Bicalutamide in people with Prostatic Neoplasms, run by Sanofi at 9 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Docetaxel, Leuprolide and Bicalutamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 9 sitesin 9 countries
- Study dates
- Jul 2007to Sep 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of prostate adenocarcinoma pathologically confirmed
- History of radical prostatectomy (pre-operative radiation therapy to the prostate or pelvis or salvage radiation after radical prostatectomy was allowed)
- Demonstration of biochemical progression of disease based on prostate specific antigen (PSA) doubling time. The minimum PSA value for eligibility was greater than or equal to (>=) 1. PSA doubling time over three values must be equal to (=) 9 months with a minimum of 3 weeks between assessments
- Serum testosterone >=100 nanogram per deciliter (ng/dL)
- Karnofsky performance status (KPS) >=70 percent (%)
- Adequate organ function as defined by the following laboratory criteria:
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- White blood cells >=3500 per cubic millimeter (mm^3)
- Absolute neutrophil count (ANC) >=1500 per mm^3
- Platelet count >=100,000 per mm^3
- Hemoglobin >= 10.0 gram per deciliter (g/dL)
- Total Bilirubin less than or equal to (<=) upper limit of normal (ULN) unless due to Gilbert's disease
- Creatinine l <= 1.5 milligram per deciliter (mg/dL) or creatinine clearance >=60 cubic centimeters per minute
- Aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase within pre-defined ranges
- Previous hormonal therapy was allowed provided that the total duration of therapy did not exceed 6 months
- Man of childbearing potential who was willing to consent to use effective contraception while on treatment and for at least 3 months thereafter
- Participant who was willing and was able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Who cannot join
- Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease
- Uncontrolled serious active infection
- Anticipated duration of life < 2 years
- Less than 5-year history of successful treatment for other cancers or concurrent active nonprostate cancer other than nonmelanoma dermatologic tumor
- Peripheral neuropathy >=Grade 2
- History of hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80, leuprolide, or bicalutamide
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- Prior chemotherapy within the past 10 years (except non-taxane based chemotherapy for treatment of other cancers); concurrent treatment on another clinical trial or with any other cancer therapy including chemotherapy, immunotherapy, radiotherapy (except salvage radiation therapy), chemoembolization therapy, cryotherapy
- Other severe acute or chronic medical conditions including psychiatric disease, or significant laboratory abnormality requiring further investigation that may cause undue risk for the participant's safety, delay or prohibit protocol participation, or interfere with the interpretation of study results, and in the judgment of the investigator would make the participant inappropriate for entry into this study
- Radiographic findings suspicious for metastatic disease in the treating physician's clinical judgment. Participant who had radiographically suspicious pelvic lymph nodes prior to radial prostatectomy, but who, at the time of enrollment did not have suspicious adenopathy was eligible. Participant was eligible even if he/she had tumor-containing pelvic adenopathy at the time of surgery as long as at the time of enrollment there was no radiographically evident nodal disease in the clinician's opinion
- Participant was the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- Participant unlikely to comply with protocol or research tests, for example, uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- Participant who participated in another clinical study/received investigational product within 30 days of screening
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
9 sites in 9 countries.
9 sites in 9 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects With a Rising PSA Following Definitive Local Therapy
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.
Read the detailed description
The duration of the study per participant was to be at least 36 months, of which the treatment period was 18 months for all participants, followed by at least 18 months follow-up period.
Participants received study treatment for up to 18 months from the time of study therapy initiation or less if one of the following occurred: disease progression, unacceptable toxicity, death, participant refusal or treatment delay beyond the time frame that is permitted for each treatment.
- Conditions
- Prostatic Neoplasms
- Being tested
- Docetaxel, Leuprolide, Bicalutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called TAXOTERE®, XRP6976
75 mg/m^2 intravenous infusion over 1 hour every 3 weeks up to 10 cycles.
LeuprolideDrug
Also called Eligard®
22.5 mg injection subcutaneously every 12 weeks up to 18 months.
BicalutamideDrug
50 mg tablet orally once daily for first 4 weeks of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel+Leuprolide+Bicalutamide | Experimental | 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. Receives: Drug: Docetaxel; Drug: Leuprolide; Drug: Bicalutamide |
| Leuprolide+Bicalutamide | Active comparator | 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. Receives: Drug: Leuprolide; Drug: Bicalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression-Free Survival (PFS) in Intent-to-treat (ITT) Population
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.
Measured: Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60
Progression-Free Survival (PFS) Rate at Month 36 in ITT Population
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.
Measured: Month 36
Median Progression-Free Survival (PFS) in Testosterone Specific Evaluable Population
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.
Measured: Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60
Progression-Free Survival (PFS) Rate at Month 36 in Testosterone Specific Evaluable Population
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.
Measured: Month 36
Secondary outcomes (6)
Overall Survival (OS): Number of Participants Who Died (All Cause)
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.
Measured: Randomization until death due to any cause, assessed up to Month 60
Cancer-Specific Survival: Number of Participants Who Died (Cancer-Specific)
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.
Measured: Randomization until death due to prostate cancer, assessed up to Month 60
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at End of Treatment (EOT)
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.
Measured: Baseline, EOT (up to Month 18)
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index (TOI) Score at EOT
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.
Measured: Baseline, EOT (up to Month 18)
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Index Score at EOT
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).
Measured: Baseline, EOT (up to Month 18)
Change From Baseline in Erectile Function Domain of International Index of Erectile Function (EF-IIEF) Total Score at EOT
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.
Measured: Baseline, EOT (up to Month 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Company decision to discontinue the study, not due to any safety or efficacy concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barrett Childs, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514917
- Sponsor's protocol ID
- XRP6976J_3503
- Other IDs
- 2007-000323-17
- Acronym
- Rising PSA
- Status last verified
- Aug 2013
- First submitted
- 2 Aug 2007
- Last updated
- 4 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects With a Rising PSA Following Definitive Local Therapy
- ClinicalTrials.gov ID
- NCT00514917
- Acronym / sponsor ID
- Rising PSA / XRP6976J_3503
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision to discontinue the study, not due to any safety or efficacy concerns
- Enrolment
- 413 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Posted 4 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The duration of the study per participant was to be at least 36 months, of which the treatment period was 18 months for all participants, followed by at least 18 months follow-up period.
Participants received study treatment for up to 18 months from the time of study therapy initiation or less if one of the following occurred: disease progression, unacceptable toxicity, death, participant refusal or treatment delay beyond the time frame that is permitted for each treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel+Leuprolide+Bicalutamide | Experimental | Drug: Docetaxel, Drug: Leuprolide, Drug: 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. |
| Leuprolide+Bicalutamide | Active comparator | Drug: Leuprolide, Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of prostate adenocarcinoma pathologically confirmed
- History of radical prostatectomy (pre-operative radiation therapy to the prostate or pelvis or salvage radiation after radical prostatectomy was allowed)
- Demonstration of biochemical progression of disease based on prostate specific antigen (PSA) doubling time. The minimum PSA value for eligibility was greater than or equal to (>=) 1. PSA doubling time over three values must be equal to (=) 9 months with a minimum of 3 weeks between assessments
- Serum testosterone >=100 nanogram per deciliter (ng/dL)
- Karnofsky performance status (KPS) >=70 percent (%)
Key exclusion criteria (13 listed)
- Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease
- Uncontrolled serious active infection
- Anticipated duration of life < 2 years
- Less than 5-year history of successful treatment for other cancers or concurrent active nonprostate cancer other than nonmelanoma dermatologic tumor
- Peripheral neuropathy >=Grade 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: TAXOTERE®, XRP697675 mg/m^2 intravenous infusion over 1 hour every 3 weeks up to 10 cycles. | Drug | Docetaxel+Leuprolide+Bicalutamide |
| LeuprolideAlso: Eligard®22.5 mg injection subcutaneously every 12 weeks up to 18 months. | Drug | Docetaxel+Leuprolide+Bicalutamide, Leuprolide+Bicalutamide |
| Bicalutamide50 mg tablet orally once daily for first 4 weeks of treatment. | Drug | Docetaxel+Leuprolide+Bicalutamide, Leuprolide+Bicalutamide |
Primary outcome
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.
6 secondary outcomes
Overall Survival (OS): Number of Participants Who Died (All Cause)
Time frame: Randomization until death due to any cause, assessed up to Month 60
Cancer-Specific Survival: Number of Participants Who Died (Cancer-Specific)
Time frame: Randomization until death due to prostate cancer, assessed up to Month 60
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)
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)
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Index Score at EOT
Time frame: Baseline, EOT (up to Month 18)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barrett Childs, MD study director
Sanofi
9 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel, Leuprolide and Bicalutamide in people with Prostatic Neoplasms, run by Sanofi at 9 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Belgium, Canada, Czechia, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2013.